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

Primary Purpose

Breast Cancer Female

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
[99mTc]Tc-G3-(G3S)3C
Sponsored by
Tomsk National Research Medical Center of the Russian Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer Female

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Subject is > 18 years of age 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 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 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 Subject is capable to undergo the diagnostic investigations to be performed in the study Informed consent Exclusion Criteria: Any system therapy (chemo-/targeted therapy) Second, non-breast malignancy Active current autoimmune disease or history of autoimmune disease 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 Administration of other investigational medicinal product within 30 days of screening Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's

Sites / Locations

  • Olga

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The tested injected doses of [99mTc]Tc-G3-(G3S)3C 3000 μg

Arm Description

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.

Outcomes

Primary Outcome Measures

Gamma camera-based whole-body [99mTc]Tc-G3-(G3S)3C uptake value (%)
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
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
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
SPECT-based [99mTc]Tc-G3-(G3S)3C background uptake value (counts)
Focal uptake of [99mTc]Tc-G3-(G3S)3C in the regions without pathological findings will be assessed with SPECT and measured in counts
Tumor-to-background ratio (SPECT)
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

Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (vital signs) (% of cases with abnormal findings relative to baseline)
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)
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (physical examination) (% of cases with abnormal findings relative to baseline)
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)
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (laboratory tests) (% of cases with abnormal findings relative to baseline)
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)
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (% of incidence and severity of adverse events)
The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the rate of adverse events (%)
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (ECG ) (% of cases with abnormal findings relative to baseline)
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)
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (% concomitant medication)
The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the rate of administration of concomitant medication (%)

Full Information

First Posted
June 19, 2023
Last Updated
July 28, 2023
Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05923268
Brief Title
Molecular Imaging of HER2 Expression in Breast Cancer Using [99mTc]Tc-G3-(G3S)3C Before Chemo/Targeted Therapy
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 4, 2023 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The tested injected doses of [99mTc]Tc-G3-(G3S)3C 3000 μg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
[99mTc]Tc-G3-(G3S)3C
Intervention Description
One single injection of [99mTc]Tc-G3-(G3S)3C, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours
Primary Outcome Measure Information:
Title
Gamma camera-based whole-body [99mTc]Tc-G3-(G3S)3C uptake value (%)
Description
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
Time Frame
6 hours
Title
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
Description
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
Title
SPECT-based [99mTc]Tc-G3-(G3S)3C background uptake value (counts)
Description
Focal uptake of [99mTc]Tc-G3-(G3S)3C in the regions without pathological findings will be assessed with SPECT and measured in counts
Time Frame
6 hours
Title
Tumor-to-background ratio (SPECT)
Description
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)
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (vital signs) (% of cases with abnormal findings relative to baseline)
Description
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)
Time Frame
24 hors
Title
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (physical examination) (% of cases with abnormal findings relative to baseline)
Description
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)
Time Frame
24 hours
Title
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (laboratory tests) (% of cases with abnormal findings relative to baseline)
Description
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)
Time Frame
Time Frame: 24 hours
Title
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (% of incidence and severity of adverse events)
Description
The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the rate of adverse events (%)
Time Frame
24 hours
Title
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (ECG ) (% of cases with abnormal findings relative to baseline)
Description
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)
Time Frame
24 hours
Title
Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (% concomitant medication)
Description
The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the rate of administration of concomitant medication (%)
Time Frame
24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is > 18 years of age 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 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 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 Subject is capable to undergo the diagnostic investigations to be performed in the study Informed consent Exclusion Criteria: Any system therapy (chemo-/targeted therapy) Second, non-breast malignancy Active current autoimmune disease or history of autoimmune disease 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 Administration of other investigational medicinal product within 30 days of screening Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Bragina, Dsc
Organizational Affiliation
Tomsk NRMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Olga
City
Tomsk
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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