99mTc-DARPinG3 SPECT/CT for Non-invasive HER2-AX in Breast Cancer With Metastatic Lymph Nodes Before Targeted Therapy

NCT05695859 | Completed

• 1 other identifier: ORI-15/12/2022-1
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

An open-label, single center study with 99mTc-DARPinG3 SPECT/CT 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-DARPinG3 SPECT/CT and standard histopathology from relevant tumor and lymph node biopsies.

Conditions

Breast Cancer Female

Keywords

99mTc-DARPinG3; breast cancer; metastatic lymph nodes; HER2

Outcome Measures

Primary Outcomes (4)

• SPECT/CT-based 99mTc-DARPinG3 uptake in tumor lesions

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

  4 hours

• SPECT/CT-based 99mTc-DARPinG3 uptake value in metastatic lymph nodes

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

  4 hours

• 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/SUV) will be divided by the value of 99mTc-DARPinG3 uptake coinciding with the regions without pathological findings (counts/SUV)

  4 hours

• LN-to-background LN ratio (SPECT)

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

  4 hours

Secondary Outcomes (1)

• Morphological and immunohistochemical verification of 99mTc-DARPinG3 accumulation

  4 hours

Interventions

99mTc-DARPinG3 SPECT/CT DRUG

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

Also known as: SPECT/CT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer female patients

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
• 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)

Russia Tomsk NRMC

Tomsk, Russia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumour biopsy

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Vladimir Chernov, MD

  Tomsk NRMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: December 20, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

RU (1)