99mTc-ADAPT6 SPECT-based Non-invasive Quantification of HER2-expression in Breast Cancer With Metastatic Lymph Nodes

NCT05412446 | Completed Phase 2

• 1 other identifier: ORI-04/03/2022-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

An open-label, single center study with 99mTc-ADAPT6 SPECT and biopsies of primary tumour and metastatic lymph nodes in breast cancer patients, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 99mTc-ADAPT6 SPECT and standard histopathology from relevant tumor and lymph node biopsies.

Conditions

Breast Cancer; Female

Keywords

99mTc-ADAPT6; Breast Cancer; metastatic lymph nodes; HER2 expression

Outcome Measures

Primary Outcomes (4)

• SPECT/CT-based 99mTc-ADAPT6 uptake value in tumor lesions (SUV)

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

  2 hours

• SPECT/CT-based 99mTc-ADAPT6 uptake value in metastatic lymph nodes (SUV)

  SPECT/CT-based 99mTc-ADAPT6 uptake value in metastatic lymph nodes SUV measured as 99mTc-ADAPT6 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2 hours after injection and measured in SUV

  2 hours

• 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 (SUV) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (SUV)

  2 hours

• LN-to-background LN ratio (SPECT)

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

  2 hours

Secondary Outcomes (1)

• Matching test rate (percentage)

  2 hours

Study Arms (2)

HER2-positive 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 Subjects withdrawn from the study for any reason will be replaced.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: ADAPT6-SPECT

HER2-negative patients

EXPERIMENTAL

Maximum 15 evaluable subjects with HER2-negative 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: ADAPT6-SPECT

Interventions

ADAPT6-SPECT DRUG

Diagnostic SPECT for HER2 expression in primary tumour and metastatic lymph nodes

Also known as: Diagnostic ADAPT6-SPECT injection

HER2-negative patients; HER2-positive patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Women with 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 lymph node metastases
• 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 8. Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Tomsk NRMC

Tomsk, 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

• Vladimir I Chernov, MD, PhD

  Caencer Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Diagnostic Test: ADAPT6-SPECT Diagnostic SPECT for HER2 expression in primary tumour and metastatic lymph nodes

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 9, 2022
• Study Start: May 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

RU (1)