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

SPECT/CT Imaging of Gastrin-releasing Peptide Receptor Expression in Breast Cancer With Different Estrogen Receptor Expression Using Technetium-99m-labelled DB8 [99mTc]Tc-DB8

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Primary Breast Cancer
• Intervention / Treatment: Drug: [99mTc]Tc-DB8

Detailed Description

The aim of the study is to determine gastrin-releasing peptide receptor expression in primary breast cancer patients with positive and negative estrogen receptor expression before any systemic or local treatment.

Phase II. Assessment of [99mTc]Tc-DB8 accumulation in primary tumors with positive and negative estrogen receptor expression in breast cancer patients.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russia
  • Tomsk, Russia
    • Russia Tomsk NRMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

3. 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
4. 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
5. Subject is capable to undergo the diagnostic investigations to be performed in the study
6. Informed consent

Exclusion Criteria:

1. Any system therapy (chemo-/targeted therapy)
2. Second, non-breast malignancy
3. Active current autoimmune disease or history of autoimmune disease
4. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breast cancer patients with positive estrogen receptor expression; Assessment of [99mTc]Tc-DB8 accumulation in primary tumour of breast cancer patients with positive estrogen receptor expression.	Drug: [99mTc]Tc-DB8; One single injection of [99mTc]Tc-DB8, followed by SPECT/CT imaging 2 hours after the injection; Other Names: Technetium-99m-labelled DB8
Experimental: Breast cancer patients with negative estrogen receptor expression; Assessment of [99mTc]Tc-DB8 accumulation in primary tumour of breast cancer patients with negative estrogen receptor expression.	Drug: [99mTc]Tc-DB8; One single injection of [99mTc]Tc-DB8, followed by SPECT/CT imaging 2 hours after the injection; Other Names: Technetium-99m-labelled DB8

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
[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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estrogen receptor positive vs estrogen receptor negative [99mTc]Tc-DB8 uptake	To evaluate the threshold values of [99mTc]Tc-DB8 accumulation for differentiation of estrogen receptor status in primary tumors in breast cancer patients	2 hours

Collaborators and Investigators

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Collaborators: Uppsala University
• Investigators: Principal Investigator: Vladimir I Chernov, MD, Prof, Tomsk NRMC

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Estimated): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Breast Cancer; [99mTc]Tc-DB8; Gastrin-releasing peptide receptor expression
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: Molecular imaging of GRPR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No