[99mTc]Tc-DB8 Accumulation in Primary Tumor in Breast Cancer With Positive and Negative Estrogen Receptor Expression

NCT07275463 | Enrolling By Invitation Phase 2

• 1 other identifier: Molecular imaging of GRPR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study should evaluate the \[99mTc\]Tc-DB8 accumulation in primary tumour of breast cancer patients with positive and negative estrogen receptor expression.

Conditions

Primary Breast Cancer

Keywords

[99mTc]Tc-DB8; Breast Cancer; Gastrin-releasing peptide receptor expression

Outcome Measures

Primary Outcomes (3)

• [99mTc]Tc-DB8 uptake in primary breast tumor

  SPECT/СT-based \[99mTc\]Tc-DB8 uptake in primary breast tumor with positive and negative estrogen receptor expression (SUVmax)

  2 hours

• [99mTc]Tc-DB8 background uptake value

  SPECT/CT-based \[99mTc\]Tc-DB8 background uptake value (SUVmax)

  2 hours

• Tumor-to-background ratio (SPECT/CT)

  The SPECT/CT-based tumor-to-background ratio will be calculated as follows: the value of \[99mTc\]Tc-DB8 uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc-DB8 uptake coinciding with the regions without pathological findings (SUVmax)

  2 hours

Secondary Outcomes (1)

• Estrogen receptor positive vs estrogen receptor negative [99mTc]Tc-DB8 uptake

  2 hours

Study Arms (2)

Breast cancer patients with positive estrogen receptor expression

EXPERIMENTAL

Assessment of \[99mTc\]Tc-DB8 accumulation in primary tumour of breast cancer patients with positive estrogen receptor expression.

Drug: [99mTc]Tc-DB8

Breast cancer patients with negative estrogen receptor expression

EXPERIMENTAL

Assessment of \[99mTc\]Tc-DB8 accumulation in primary tumour of breast cancer patients with negative estrogen receptor expression.

Drug: [99mTc]Tc-DB8

Interventions

[99mTc]Tc-DB8 DRUG

One single injection of \[99mTc\]Tc-DB8, followed by SPECT/CT imaging 2 hours after the injection

Also known as: Technetium-99m-labelled DB8

Breast cancer patients with negative estrogen receptor expression; Breast cancer patients with positive estrogen receptor expression

Eligibility Criteria

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

You may qualify if:

• Subject is \> 18 years of age
• Availability of results from estrogen receptor status by Immunohistochemistry previously determined on material from the primary tumor
• 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

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, Prof

  Tomsk NRMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Diagnostic SPECT for GRPR expression in primary tumour

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.
• Access Criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.

Locations

RU (1)