Feasibility of the LUM Imaging System for Detection of Cancer to the Brain
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ClinicalTrials.gov Identifier: NCT03717142 |
Recruitment Status :
Suspended
(Protocol requires amendment prior to continuing enrollment)
First Posted : October 24, 2018
Last Update Posted : March 12, 2024
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Tracking Information | |||||||
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First Submitted Date ICMJE | October 22, 2018 | ||||||
First Posted Date ICMJE | October 24, 2018 | ||||||
Last Update Posted Date | March 12, 2024 | ||||||
Actual Study Start Date ICMJE | May 3, 2019 | ||||||
Estimated Primary Completion Date | June 2025 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Correlation of fluorescence levels in normal and tumor tissue by dose of LUM015 [ Time Frame: Day 1 ] Correlate the fluorescence levels in normal and tumor tissue from specimen imaging to the dose of LUM015 injected, or if not injected. Determine initial efficacy of LUM015 in labeling primary and metastatic cancer in the Brain by molecular imaging compared with imaging results in pathology.
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Original Primary Outcome Measures ICMJE |
Determine initial efficacy of LUM015 in labeling primary and metastatic cancer in the Brain by molecular imaging compared with imaging results in pathology [ Time Frame: Day 1 ] Correlate the fluorescence levels in normal and tumor tissue from specimen imaging to the dose of LUM015 injected, or if not injected.
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Current Secondary Outcome Measures ICMJE |
Number of reported safety events [ Time Frame: up to 14 days post surgery ] Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity
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Original Secondary Outcome Measures ICMJE |
Collect safety data of LUM015 in subjects [ Time Frame: up to 14 days post surgery ] Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Feasibility of the LUM Imaging System for Detection of Cancer to the Brain | ||||||
Official Title ICMJE | Feasibility of the LUM Imaging System for In Vivo and Ex Vivo Detection of Cancer in Subjects With Low Grade Gliomas, Glioblastomas, and Cancer Metastases to the Brain | ||||||
Brief Summary | The overall objective of this study is to assess the safety and efficacy of the LUM Imaging System in imaging primary and metastatic cancer in the brain. This includes selecting a dose to determine the initial efficacy of LUM015 for the molecular imaging of low-grade gliomas, glioblastomas and cancer masses that have metastasized to the brain. | ||||||
Detailed Description | The primary objective of this feasibility study is to identify an effective dose of LUM015 for imaging low grade gliomas, glioblastomas and cancer metastases to the brain. The optimal dose will be used for future studies. Both normal brain tissue and tumor tissue will be imaged and analyzed using the LUM Imaging device. The LUM Imaging System is a combination product consisting of the LUM Imaging Device and the imaging agent LUM015. Subjects with a possible diagnosis of low grade glioma, glioblastoma and metastases to the brain, and scheduled for surgical resection, will be screened, recruited. On day of scheduled surgery, the subject will be administered with LUM015 4 ± 2 hours prior to using LUM Imaging System during surgery. LUM015 will be administered via peripheral intravenous (IV) injection as a single dose between 1.0 - 3.0 mg/kg. Before the tumor mass is resected, the LUM Imaging Device will be used to scan images of distinct areas of grossly normal appearing brain tissue and, separately, images of distinct areas of grossly appearing tumor. Following tumor mass resection, the tumor bed is scanned to record in vivo images. The resected tissue will also be imaged ex vivo. All subjects will continue to be monitored until hospital discharge and followed through their first standard of care post-surgical visit. Subjects with adverse events that are determined to be possibly related to the investigational product will continue to be followed until resolution or stabilization of the adverse event. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Intervention Model Description: Dose Escalation Masking: None (Open Label)Primary Purpose: Other |
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Condition ICMJE |
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Intervention ICMJE | Combination Product: LUM Imaging System
Patients will be injected with one of 3 study doses of LUM015, or have no LUM015 intervention, and tissue will be imaged in vivo and ex vivo with the LUM imaging device.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Suspended | ||||||
Estimated Enrollment ICMJE |
36 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | September 2025 | ||||||
Estimated Primary Completion Date | June 2025 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03717142 | ||||||
Other Study ID Numbers ICMJE | CL0004 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Lumicell, Inc. | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Lumicell, Inc. | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Lumicell, Inc. | ||||||
Verification Date | March 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |