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Molecular Imaging of HER2 Expression in Breast Cancer Using [99mTc]Tc-G3-(G3S)3C Before Chemo/Targeted Therapy

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ClinicalTrials.gov Identifier: NCT05923268
Recruitment Status : Enrolling by invitation
First Posted : June 28, 2023
Last Update Posted : August 1, 2023
Sponsor:
Information provided by (Responsible Party):
Tomsk National Research Medical Center of the Russian Academy of Sciences

Study Description
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Brief Summary:
The study should evaluate distribution of [99mTc]Tc-G3-(G3S)3C in patients with primary HER2-positive and HER2-negative breast cancer

Condition or disease Intervention/treatment Phase
Breast Cancer Female Drug: [99mTc]Tc-G3-(G3S)3C Not Applicable

Detailed Description:

Overall goal of the project: To determine HER2 expression level in primary breast cancer before neoadjuvant system therapy (chemotherapy or/and targeted therapy).

Phase I. Distribution of [99mTc]Tc-G3-(G3S)3C in patients with primary breast cancer. The study should evaluate distribution of [99mTc]Tc-G3-(G3S)3C in patients with primary HER2-positive and HER2-negative breast cancer.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Using Technetium-99m-labelled Designed Ankyrin Repeat Proteins ([99mTc]Tc-G3-(G3S)3C)
Actual Study Start Date : June 4, 2023
Estimated Primary Completion Date : June 15, 2024
Estimated Study Completion Date : June 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: The tested injected doses of [99mTc]Tc-G3-(G3S)3C 3000 μg

At least five (5) evaluable subjects with HER2-positive status and at least five (5) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose 3000 μg.

Subjects withdrawn from the study for any reason will be replaced.

 Drug: [99mTc]Tc-G3-(G3S)3C
One single injection of [99mTc]Tc-G3-(G3S)3C, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours


Outcome Measures
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Primary Outcome Measures :
  1. Gamma camera-based whole-body [99mTc]Tc-G3-(G3S)3C uptake value (%) [ Time Frame: 6 hours ]
    Whole-body [99mTc]Tc-G3-(G3S)3C uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical

  2. SPECT-based [99mTc]Tc-G3-(G3S)3C uptake value in tumor lesions (counts) [99mTc]Tc-G3-(G3S)3C uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts [ Time Frame: 6 hours ]
    SPECT-based [99mTc]Tc-G3-(G3S)3C uptake value in tumor lesions (counts) [99mTc]Tc-G3-(G3S)3C uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts

  3. SPECT-based [99mTc]Tc-G3-(G3S)3C background uptake value (counts) [ Time Frame: 6 hours ]
    Focal uptake of [99mTc]Tc-G3-(G3S)3C in the regions without pathological findings will be assessed with SPECT and measured in counts

  4. Tumor-to-background ratio (SPECT) [ Time Frame: 6 hours ]
    The SPECT-based tumor-to-background ratio will be calculated as follows: the value of [99mTc]Tc-G3-(G3S)3C uptake coinciding with tumor lesions (counts) will be divided by the value of [99mTc]Tc-G3-(G3S)3C uptake coinciding with the regions without pathological findings (counts)


Secondary Outcome Measures :
  1. Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (vital signs) (% of cases with abnormal findings relative to baseline) [ Time Frame: 24 hors ]
    The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the assessments of vital signs (% of cases with abnormal findings relative to baseline)

  2. Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (physical examination) (% of cases with abnormal findings relative to baseline) [ Time Frame: 24 hours ]
    The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the assessments of physical examination (% of cases with abnormal findings relative to baseline)

  3. Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (laboratory tests) (% of cases with abnormal findings relative to baseline) [ Time Frame: Time Frame: 24 hours ]
    The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the blood and urine laboratory tests (% of cases with abnormal findings relative to baseline)

  4. Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (% of incidence and severity of adverse events) [ Time Frame: 24 hours ]
    The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the rate of adverse events (%)

  5. Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (ECG ) (% of cases with abnormal findings relative to baseline) [ Time Frame: 24 hours ]
    The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the assessments of ECG (% of cases with abnormal findings relative to baseline)

  6. Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (% concomitant medication) [ Time Frame: 24 hours ]
    The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the rate of administration of concomitant medication (%)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is > 18 years of age
  2. Availability of results from HER2 status previously determined on material from the primary tumor and metastatic LN, either a. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative

  3. Hematological, liver and renal function test results within the following limits:

    • White blood cell count: > 2.0 x 109/L
    • Hemoglobin: > 80 g/L
    • Platelets: > 50.0 x 109/L
    • ALT, ALP, AST: =< 5.0 times Upper Limit of Normal
    • Bilirubin =< 2.0 times Upper Limit of Normal
    • Serum creatinine: Within Normal Limits
  4. A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination
  5. Subject is capable to undergo the diagnostic investigations to be performed in the study
  6. Informed consent

Exclusion Criteria:

  1. Any system therapy (chemo-/targeted therapy)
  2. Second, non-breast malignancy
  3. Active current autoimmune disease or history of autoimmune disease
  4. Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C
  5. Administration of other investigational medicinal product within 30 days of screening
  6. Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05923268


Locations
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Russian Federation
Olga
Tomsk, Russian Federation
Sponsors and Collaborators
Tomsk National Research Medical Center of the Russian Academy of Sciences
Investigators
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Principal Investigator: Olga Bragina, Dsc Tomsk NRMC
More Information
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Responsible Party: Tomsk National Research Medical Center of the Russian Academy of Sciences
ClinicalTrials.gov Identifier: NCT05923268    
Other Study ID Numbers: [99mTc]Tc-G3-(G3S)3C
First Posted: June 28, 2023    Key Record Dates
Last Update Posted: August 1, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases