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

NCT05376644 | Completed

• 1 other identifier: ORI-04/03/2022-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Keywords

99mTc-ADAPT6; 99mTc-DARPinG3; Breast Cancer; HER2 expression

Outcome Measures

Primary Outcomes (6)

• 99mTc-ADAPT6 uptake (counts)/SUV

  SPECT/CT-based 99mTc-ADAPT6 uptake value in primary tumor lesions (counts)/SUV of 99mTc-ADAPT6 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2 hours after injection and measured in counts and SUV.

  2 hours

• 99mTc-ADAPT6 tumor-to-background ratio (SPECT)

  The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-ADAPT6 uptake coinciding with tumor lesions (counts/SUV) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (counts)

  2 hours

• 99mTc-DARPinG3 uptake (counts)/SUV

  SPECT/CT-based 99mTc-DARPinG3 uptake value in primary tumor lesions (counts)/SUV of 99mTc-DARPinG3 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 4 hours after injection and measured in counts and SUV

  4 hours

• 99mTc-DARPinG3 tumor-to-background ratio (SPECT)

  The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-DARPinG3 uptake coinciding with tumor lesions (counts) will be divided by the value of 99mTc-DARPinG3 uptake coinciding with the regions without pathological findings (counts/the value of 99mTc-ADAPT6 and 99mTc-DARPinG3 uptake coinciding with tumor lesions (counts) will be divided by the value of 99mTc-ADAPT6 and 99mTc-DARPinG3 uptake coinciding with the regions without pathological findings (counts/SUV)

  4 hours

• 99mTc-ADAPT6 vs 99mTc-DARPinG3 uptake (counts)/SUV

  Comparison of SPECT/CT-based 99mTc-ADAPT6 versus 99mTc-DARPinG3 uptake value in primary tumor lesions (counts)/SUV of 99mTc-ADAPT6 and 99mTc-DARPinG3 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2 and 4 hours after injection and measured in counts and SUV.

  2 and 4 hours

• 99mTc-ADAPT6 vs 99mTc-DARPinG3 tumor-to-background ratio (SPECT)

  Comparison of the value of 99mTc-ADAPT6 versus 99mTc-DARPinG3 uptake coinciding with tumor lesions (counts/SUV) divided by the value of 99mTc-ADAPT6 and 99mTc-DARPinG3 uptake coinciding with the regions without pathological findings (counts/SUV)

  2 and 4 hours

Secondary Outcomes (2)

• 99mTc-ADAPT6 vs immunohistochemical studies (percent)

  2 hours

• 99mTc-DARPinG3 vs immunohistochemical studies (percent)

  4 hours

Study Arms (1)

HER2 positive breast cancer patients

EXPERIMENTAL

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

Drug: 99mTc-ADAPT6; Drug: 99mTc-DARPinG3

Interventions

99mTc-ADAPT6 DRUG

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

Also known as: SPECT

HER2 positive breast cancer patients

99mTc-DARPinG3 DRUG

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

Also known as: SPECT

HER2 positive breast cancer patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Women with primary HER2-positive breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is \> 18 years of age;
• Diagnosis of primary breast cancer with possible lymph node metastases before system (chemo+targeted therapy);
• 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;
• Sequential injection of 99mTc-ADAPT6 and 99mTc-DARPinG3 in the interval of 3-4 days in each HER2-positive breast cancer patient;
• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead
• Uppsala University: collaborator

Study Sites (1)

Tomsk NRMC

Tomsk, 634005, Russia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Olga Bragina, MD, Dsc

  Tomsk NRMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Diagnostic Test: ADAPT6-SPECT and DARPinG3-SPECT Diagnostic SPECT for HER2-positive Breast Cancer primary tumour

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 17, 2022
• Study Start: May 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 21, 2023
• Last Updated: June 29, 2026

Record last verified: 2023-04

Locations

RU (1)