Investigation of Novel Surgical Imaging for Tumor Excision (INSITE)

• ClinicalTrials.gov Identifier: NCT03686215
• Recruitment Status: Completed
• First Posted: September 26, 2018
• Results First Posted: August 24, 2023
• Last Update Posted: August 24, 2023
• Sponsor: Lumicell, Inc.
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Lumicell, Inc.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Breast Cancer
• Intervention: Combination Product: Study Device Arm
• Enrollment: 406

Participant Flow

Recruitment Details	406 injected with LUM015 (LUMISIGHT), 14 withdrawn before randomization.
Pre-assignment Details

Arm/Group Title	Device Intervention: Lum Imaging Device Used During Surgery	Standard of Care Arm	Withdrawn Before Randomization
Arm/Group Description	The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015. Study Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.	The LUM Imaging Device was not used to guide additional tissue removal. Patients in this arm received the study drug, LUM015.	All the patients injected with LUM015 but withdrawn before randomization after standard of care.
Period Title: Overall Study
Started	357	35	14
Completed	356	35	0
Not Completed	1	0	14
Reason Not Completed
Adverse Event	0	0	7
Physician Decision	0	0	1
Protocol Violation	0	0	4
Device issue	1	0	2

Baseline Characteristics

Arm/Group Title		Device Intervention: LUM Imaging System Used During Surgery	Standard of Care Arm	Withdrawn Before Randomization	Total
Arm/Group Description		The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015. Study Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.	The LUM Imaging Device was not used to guide additional tissue removal. Patients in this arm received the study drug, LUM015.	All the patients injected with LUM015 but withdrawn before randomization.	Total of all reporting groups
Overall Number of Baseline Participants		357	35	14	406
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	357 participants	35 participants	14 participants	406 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	184 51.5%	19 54.3%	8 57.1%	211 52.0%
	>=65 years	173 48.5%	16 45.7%	6 42.9%	195 48.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	357 participants	35 participants	14 participants	406 participants
		62.4 (9.6)	61.6 (9.9)	61.6 (11.6)	62.3 (9.7)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	357 participants	35 participants	14 participants	406 participants
	Female	357 100.0%	35 100.0%	14 100.0%	406 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	357 participants	35 participants	14 participants	406 participants
	Hispanic or Latino	11 3.1%	1 2.9%	0 0.0%	12 3.0%
	Not Hispanic or Latino	336 94.1%	34 97.1%	13 92.9%	383 94.3%
	Unknown or Not Reported	10 2.8%	0 0.0%	1 7.1%	11 2.7%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	357 participants	35 participants	14 participants	406 participants
	American Indian or Alaska Native	0 0.0%	1 2.9%	0 0.0%	1 0.2%
	Asian	21 5.9%	1 2.9%	0 0.0%	22 5.4%
	Native Hawaiian or Other Pacific Islander	1 0.3%	0 0.0%	0 0.0%	1 0.2%
	Black or African American	22 6.2%	4 11.4%	0 0.0%	26 6.4%
	White	297 83.2%	27 77.1%	13 92.9%	337 83.0%
	More than one race	4 1.1%	0 0.0%	0 0.0%	4 1.0%
	Unknown or Not Reported	12 3.4%	2 5.7%	1 7.1%	15 3.7%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	357 participants	35 participants	14 participants	406 participants
		357	35	14	406
Body Mass Index; Mean (Standard Deviation); Unit of measure: Kg/m^2
	Number Analyzed	357 participants	35 participants	14 participants	406 participants
		29.8 (6.7)	31.0 (5.9)	29.8 (6.8)	29.9 (6.6)
Menopausal Status; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	357 participants	35 participants	14 participants	406 participants
	Post	299 83.8%	28 80.0%	12 85.7%	339 83.5%
	Pre/Peri	58 16.2%	7 20.0%	2 14.3%	67 16.5%
Mammographic breast density; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	357 participants	35 participants	14 participants	406 participants
	Almost Entirely Fatty	5 1.4%	0 0.0%	0 0.0%	5 1.2%
	Scattered Areas of Fibroglandular Density	196 54.9%	20 57.1%	4 28.6%	220 54.2%
	Heterogeneously Dense	140 39.2%	13 37.1%	10 71.4%	163 40.1%
	Extremely Dense	11 3.1%	2 5.7%	0 0.0%	13 3.2%
	Unknown	5 1.4%	0 0.0%	0 0.0%	5 1.2%
Palpability; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	357 participants	35 participants	14 participants	406 participants
	Palpable Mass	85 23.8%	11 31.4%	4 28.6%	100 24.6%
	Not palpable Mass	272 76.2%	24 68.6%	10 71.4%	306 75.4%
Tumor Histology From Biopsy; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	357 participants	35 participants	14 participants	406 participants
	DCIS only	70 19.6%	6 17.1%	2 14.3%	78 19.2%
	IDC +/- DCIS	249 69.7%	25 71.4%	10 71.4%	284 70.0%
	ILC +/- DCIS	35 9.8%	4 11.4%	2 14.3%	41 10.1%
	IDC + ILC	3 0.8%	0 0.0%	0 0.0%	3 0.7%
Estrogen Receptor (ER) (+) Genetic Marker from Biopsy; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	357 participants	35 participants	14 participants	406 participants
	ER (+)	335 93.8%	30 85.7%	13 92.9%	378 93.1%
	ER (-)	19 5.3%	5 14.3%	1 7.1%	25 6.2%
	Not available	3 0.8%	0 0.0%	0 0.0%	3 0.7%
Progesterone Receptor (PR) (+) Genetic Marker from Biopsy; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	357 participants	35 participants	14 participants	406 participants
	PR (+)	272 76.2%	28 80.0%	11 78.6%	311 76.6%
	PR (-)	48 13.4%	5 14.3%	1 7.1%	54 13.3%
	Unknown	37 10.4%	2 5.7%	2 14.3%	41 10.1%
Human Epidermal growth factor Receptor 2 (HER2) (+) Genetic Marker from Biopsy; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	357 participants	35 participants	14 participants	406 participants
	HER2 (+)	20 5.6%	3 8.6%	0 0.0%	23 5.7%
	HER2 (-)	280 78.4%	26 74.3%	13 92.9%	319 78.6%
	Unknown	57 16.0%	6 17.1%	1 7.1%	64 15.8%
Triple Negatives Genetic Marker from Biopsy; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	357 participants	35 participants	14 participants	406 participants
	Triple Negatives - Yes	11 3.1%	3 8.6%	1 7.1%	15 3.7%
	Triple Negatives - No	346 96.9%	32 91.4%	13 92.9%	391 96.3%
Lymph Nodes Biopsy; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	357 participants	35 participants	14 participants	406 participants
	Lymph Node (+)	9 2.5%	1 2.9%	0 0.0%	10 2.5%
	Lymph Node (-)	51 14.3%	7 20.0%	2 14.3%	60 14.8%
	No Lymph Node Biopsy	297 83.2%	27 77.1%	12 85.7%	336 82.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients Who Had Residual Cancer Found in at Least One LUM Imaging System Guided Shave Among All Patients.
Description	Residual cancer was defined as tumor found by pathology in a therapeutic shave after the SOC surgical procedure was completed; that is, tumor that current Standard of Care (SOC) surgery failed to remove. LUM Imaging System was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available.
Time Frame	Day 1, during surgery

Outcome Measure Data

Analysis Population Description

modified intent to treat population (mITT) includes subjects injected with LUM015 and LUM Imaging was performed

Arm/Group Title	Device Intervention: LUM Imaging System Used
Arm/Group Description:	The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015. Study Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.
Overall Number of Participants Analyzed	357
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	7.6; (5.0 to 10.8)

2. Primary Outcome

Title	Sensitivity of LUM Imaging System on Cancer in the Lumpectomy Cavity
Description	Sensitivity of LUM Imaging System on cancer was calculated as percentage of tissues with cancer that was removed from lumpectomy cavity due to positive detection by LUM Imaging System. The estimates of the instrument diagnostic sensitivity used Generalized Estimating Equations (GEE) approach. This method was used to analyze correlated data which was modeled with generalized linear model having binomial link function and including correlation cluster and matrix information (here within each subject). LUM Imaging System was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available.
Time Frame	Day 1, during surgery

Outcome Measure Data

Analysis Population Description

modified intent to treat population (mITT) includes subjects injected with LUM015 and LUM Imaging was performed

Arm/Group Title	Device Intervention: LUM Imaging System Used During Surgery
Arm/Group Description:	The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015. Study Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.
Overall Number of Participants Analyzed	357
Overall Number of Units Analyzed; Type of Units Analyzed: Tissue with cancer	69
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of tissues with cancer
	49.1; (36.4 to 61.9)

3. Primary Outcome

Title	Specificity of LUM Imaging System Detection on Cancer in the Lumpectomy Cavity
Description	Specificity of LUM Imaging System Detection on Cancer in the Lumpectomy Cavity was measured as percentage of the negative margins without cancer, that were tested negative by LUM Imaging System. The estimate of the instrument diagnostic specificity used Generalized Estimating Equations (GEE) approach with random effects from intraclass correlation within subjects.
Time Frame	Day 1, during surgery

Outcome Measure Data

Analysis Population Description

modified intent to treat population (mITT) includes subjects injected with LUM015 and LUM Imaging was performed

Arm/Group Title	Device Intervention: LUM Imaging System Used During Surgery
Arm/Group Description:	The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015. Study Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.
Overall Number of Participants Analyzed	357
Overall Number of Units Analyzed; Type of Units Analyzed: Negative margins without cancer	2277
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of negative margins w/o ca
	86.5; (84.5 to 88.3)

4. Secondary Outcome

Title	Detection and Conversion of Positive Margins.
Description	Detection of positive margins: Percentage of patients with positive margins after standard of care breast-conserving surgery, all had LUM Imaging System signals above the threshold in the cavity as defined by the tumor detection algorithm. Conversion of positive margins: Percentage of patients with positive margins after standard of care breast-conserving surgery resulted in the negative margin after LUM Imaging System was used. The system was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available.
Time Frame	Day 1, during surgery

Outcome Measure Data

Analysis Population Description

modified intent to treat population (mITT) includes subjects injected with LUM015 and LUM Imaging was performed

Arm/Group Title		Device Intervention: LUM Imaging System Used During Surgery
Arm/Group Description:		The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015. Study Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.
Overall Number of Participants Analyzed		357
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Percentage among participants having positive margins after SoC all detected by LUM Imaging System	Number Analyzed	62 participants
		16.1; (8.0 to 27.7)
Percentage of participants with positive SOC margins converted to negative with LUM Imaging System	Number Analyzed	62 participants
		14.5; (6.9 to 25.8)

5. Secondary Outcome

Title	Removal of Residual Cancer Guided by the LUM Imaging System in Participants With Negative Margins After Standard-of-Care Surgery
Description	Percentage of participants having residual tumor removed within subpopulation of having negative margins after Standard of Care surgery. The system was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available.
Time Frame	Day 1, during surgery

Outcome Measure Data

Analysis Population Description

Participants having negative margin after standard of care procedure of lumpectomy.

Arm/Group Title	Device Intervention: LUM Imaging System Used During Surgery
Arm/Group Description:	The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015. Study Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.
Overall Number of Participants Analyzed	295
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	6.4; (3.9 to 9.9)

6. Secondary Outcome

Title	Removal of Residual Cancer Guided by the LUM Imaging System in Subjects With Positive Margins After Standard-of-Care Surgery
Description	Percentage of participants having residual tumor removed within subpopulation of having positive margins after Standard of Care surgery. The system was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available.
Time Frame	Day 1, during surgery

Outcome Measure Data

Analysis Population Description

Participants with positive margins after standard of care procedure of lumpectomy.

Arm/Group Title	Device Intervention: LUM Imaging System Used During Surgery
Arm/Group Description:	The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015. Study Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.
Overall Number of Participants Analyzed	62
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	12.9; (5.7 to 23.9)

7. Secondary Outcome

Title	Volume of Therapeutic Shaves Removed During Lumpectomy.
Description	The median volumes of Lumicell Imaging System - guided shaves (therapeutic shaves) were measured and the median total volume removed during lumpectomy was presented as well. The system was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available.
Time Frame	Day 1, during surgery

Outcome Measure Data

Analysis Population Description

mITT and control populations

Arm/Group Title	Device Intervention: LUM Imaging System Used During Surgery	Standard of Care Arm
Arm/Group Description:	The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015. Study Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.	The LUM Imaging Device was not used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015.
Overall Number of Participants Analyzed	357	35
Median (95% Confidence Interval); Unit of Measure: cm^3
Lumpectomy volume	54; (9.7 to 267.2)	66.8; (10.5 to 308.0)
SOC shave volume	7.5; (0 to 71.2)	7.7; (0 to 71.9)
SOC total volume	66.4; (15.1 to 308.7)	76.7; (21.9 to 308)
Therapeutic shave volume	0; (0 to 61.1)	0; (0 to 0)
Total volume	77.5; (15.2 to 348.1)	76.7; (21.9 to 308.0)

8. Secondary Outcome

Title	Contribution of Therapeutic Shaves to Total Volume Removed During Lumpectomy.
Description	Median of the percentages of the volumes of Lumicell Imaging System - guided shaves (therapeutic shaves) out of total volume removed during lumpectomy for each participant were measured. The system was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available.
Time Frame	Day 1, during surgery

Outcome Measure Data

Analysis Population Description

mITT and Control arm populations

Arm/Group Title	Device Intervention: LUM Imaging System Used During Surgery	Standard of Care Arm
Arm/Group Description:	The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015. Study Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.	The LUM Imaging Device was not used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015.
Overall Number of Participants Analyzed	357	35
Median (95% Confidence Interval); Unit of Measure: Percent
	0; (0 to 44.7)	0; (0 to 0)

Adverse Events

Time Frame	All adverse events and adverse device effects, both serious and non-serious, and deaths that are encountered from initiation of study intervention, throughout the study, and within the first post-operative follow-up visit should be followed to their resolution, or until the principal investigator assesses them as stable, or the principal investigator determines the event to be irreversible, or the subject is lost to follow-up. Adverse events were assessed up to 30 days after enrollment.
Adverse Event Reporting Description	Serious adverse events should be reported within 24 hours of learning of the occurrence. Non-serious adverse events and non-serious adverse device effects will be reported to Lumicell on the adverse events Case Report Forms during the study.
Arm/Group Title	Device Intervention: LUM Imaging System Used During Surgery		Standard of Care Arm		Withdrawn Before Randomization
Arm/Group Description	The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015. Study Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.		The LUM Imaging Device was not used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015.		All the patients injected with LUM015 but withdrawn before randomization.
All-Cause Mortality
	Device Intervention: LUM Imaging System Used During Surgery		Standard of Care Arm		Withdrawn Before Randomization
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/357 (0.00%)		0/35 (0.00%)		0/14 (0.00%)
Serious Adverse Events
	Device Intervention: LUM Imaging System Used During Surgery		Standard of Care Arm		Withdrawn Before Randomization
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/357 (0.84%)		0/35 (0.00%)		2/14 (14.29%)
Immune system disorders
Hypersensitivity † 1	0/357 (0.00%)	0	0/35 (0.00%)	0	1/14 (7.14%)	1
Anaphylactic reaction † 1	0/357 (0.00%)	0	0/35 (0.00%)	0	1/14 (7.14%)	1
Infections and infestations
Breast cellulitis † 1	1/357 (0.28%)	1	0/35 (0.00%)	0	0/14 (0.00%)	0
Injury, poisoning and procedural complications
Vascular pseudoaneurysm † 1	1/357 (0.28%)	1	0/35 (0.00%)	0	0/14 (0.00%)	0
Nervous system disorders
Somnolence † 1	1/357 (0.28%)	1	0/35 (0.00%)	0	0/14 (0.00%)	0
Renal and urinary disorders
Acute kidney injury † 1	1/357 (0.28%)	1	0/35 (0.00%)	0	0/14 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure † 1	1/357 (0.28%)	1	0/35 (0.00%)	0	0/14 (0.00%)	0
1 Term from vocabulary, MedDRA version 22.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	Device Intervention: LUM Imaging System Used During Surgery		Standard of Care Arm		Withdrawn Before Randomization
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	334/357 (93.56%)		32/35 (91.43%)		13/14 (92.86%)
Gastrointestinal disorders
Nausea † 1	11/357 (3.08%)	11	1/35 (2.86%)	1	2/14 (14.29%)	2
Constipation † 1	2/357 (0.56%)	2	2/35 (5.71%)	2	0/14 (0.00%)	0
General disorders
Fatigue † 1	6/357 (1.68%)	6	0/35 (0.00%)	0	0/14 (0.00%)	0
Extravasation † 1	1/357 (0.28%)	2	0/35 (0.00%)	0	2/14 (14.29%)	2
Injury, poisoning and procedural complications
Procedural pain † 1	10/357 (2.80%)	10	0/35 (0.00%)	0	0/14 (0.00%)	0
Contusion † 1	5/357 (1.40%)	5	0/35 (0.00%)	0	0/14 (0.00%)	0
Seroma † 1	22/357 (6.16%)	22	3/35 (8.57%)	3	0/14 (0.00%)	0
Investigations
Blood creatinine decreased † 1	3/357 (0.84%)	3	0/35 (0.00%)	0	1/14 (7.14%)	1
Renal and urinary disorders
Chromaturia † 1	325/357 (91.04%)	325	30/35 (85.71%)	30	13/14 (92.86%)	13
Reproductive system and breast disorders
Breast pain † 1	20/357 (5.60%)	22	1/35 (2.86%)	1	1/14 (7.14%)	2
Skin and subcutaneous tissue disorders
Erythema † 1	6/357 (1.68%)	6	0/35 (0.00%)	0	0/14 (0.00%)	0
Ecchymosis † 1	5/357 (1.40%)	5	0/35 (0.00%)	0	0/14 (0.00%)	0
Rash † 1	4/357 (1.12%)	5	1/35 (2.86%)	1	0/14 (0.00%)	0
Pruritus † 1	4/357 (1.12%)	4	0/35 (0.00%)	0	0/14 (0.00%)	0
Vascular disorders
Haematoma † 1	4/357 (1.12%)	4	0/35 (0.00%)	0	0/14 (0.00%)	0
1 Term from vocabulary, MedDRA version 22.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

Our trial did not take additional margin specimens from cavity orientations with negative Pegulicianine fluorescence-guided (pFGS) readings but scored the pFGS cavity reading as falsely negative if the corresponding lumpectomy margin was positive.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Jorge Ferrer, PhD
• Organization: Lumicell
• Phone: 617-571-0592
• EMail: jmferrer@lumicell.com

• Responsible Party: Lumicell, Inc.
• ClinicalTrials.gov Identifier: NCT03686215
• Other Study ID Numbers: CL0007; 5R44CA211013-02 ( U.S. NIH Grant/Contract )
• First Submitted: September 25, 2018
• First Posted: September 26, 2018
• Results First Submitted: May 5, 2023
• Results First Posted: August 24, 2023
• Last Update Posted: August 24, 2023