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

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05923268
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12.4
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated 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: Jun 4, 2023
• Anticipated Primary Completion Date: Jun 15, 2024
• Anticipated Study Completion Date: Jun 15, 2024

Arms and Interventions

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 Subjects withdrawn from the study for any reason will be replaced.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

Primary Outcome Measures

1. Gamma camera-based whole-body [99mTc]Tc-G3-(G3S)3C uptake value (%) [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 [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) [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) [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) [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) [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) [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 (incidence and severity of adverse events) [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 ) [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) [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

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

1. 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

2. Subject is capable to undergo the diagnostic investigations to be performed in the study

3. 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

Locations

	Site	City	State	Country	Postal Code
1	Olga	Tomsk		Russian Federation

Sponsors and Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences

Investigators

• Principal Investigator: Olga Bragina, Dsc, Tomsk NRMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Jun 28, 2023
• Last Update Posted: Jun 28, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jun 28, 2023