Molecular Imaging of HER2 Expression in HER2-positive Breast Cancer Using 99mTc-ADAPT6 vs 99mTc-DARPinG3

NCT ID: NCT05376644

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-01-21

Brief Summary

An open-label, single center study with 99mTc-ADAPT6 and 99mTc-DARPinG3 SPECT and biopsies of primary tumour in HER2-positive Breast Cancer before system (chemo/targeted) therapy, where the primary endpoint of the study is to compare imaging properties of 99mTc-ADAPT6 and 99mTc-DARPin G3 SPECT in HER2-positive breast cancer patients.

Detailed Description

The primary objectives are:

Compare SPECT/CT imaging properties of 99mTc-ADAPT6 and 99mTc-DARPin G3 in HER2-positive primary tumour of breast cancer patients before system (chemo/targeted) therapy.

The secondary objectives are:

To compare the SPECT/CT tumor imaging data with the data concerning HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples.

Conditions

Breast Cancer Female

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

HER2 positive breast cancer patients

Maximum (15) evaluable subjects with HER2-positive status in primary tumour before chemo/targeted therapy have to be enrolled in the study. Subjects withdrawn from the study for any reason will be replaced

Group Type: EXPERIMENTAL

99mTc-ADAPT6

Intervention Type: DRUG

One single injection of 99mTc-ADAPT6, followed by gamma camera imaging 2 hours after injection.

99mTc-DARPinG3

Intervention Type: DRUG

One single injection of 99mTc-DARPinG3, followed by gamma camera imaging 4 hours after injection.

Interventions

99mTc-ADAPT6

One single injection of 99mTc-ADAPT6, followed by gamma camera imaging 2 hours after injection.

Intervention Type: DRUG

99mTc-DARPinG3

One single injection of 99mTc-DARPinG3, followed by gamma camera imaging 4 hours after injection.

Intervention Type: DRUG

Other Intervention Names

SPECT; SPECT

Eligibility Criteria

Inclusion Criteria

1. Subject is > 18 years of age;

2. Diagnosis of primary breast cancer with possible lymph node metastases before system (chemo+targeted therapy);

3. Availability of results from HER2 status previously determined on material from the primary tumor: HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive;

4. Sequential injection of 99mTc-ADAPT6 and 99mTc-DARPinG3 in the interval of 3-4 days in each HER2-positive breast cancer patient;

5. 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

6. 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;

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

8. Informed consent

Exclusion Criteria

1. Second, non-breast malignancy 2. Active current autoimmune disease or history of autoimmune disease 3. 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

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: collaborator

Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olga Bragina, MD, Dsc

Role: PRINCIPAL_INVESTIGATOR

Tomsk NRMC

Locations

Tomsk NRMC

Tomsk, , Russia

Countries

Russia

Other Identifiers

99mTc-ADAPT6 vs 99mTc-DARPinG3

Identifier Type: -

Identifier Source: org_study_id