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ENROLLING BY INVITATION
NCT07784660
PHASE1

Molecular Imaging of EpCam Expression in Breast Cancer Using [99mTc]Tc-DARPinEc1-G3C

Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

View on ClinicalTrials.gov

Summary

The study should evaluate distribution of \[99mTc\]Tc-DARPinEc1-G3C in patients with primary Triple negative and Luminal breast cancer. The primary objective are: 1. To assess distribution of \[99mTc\]Tc-DARPinEc1-G3C in normal tissues and in tumors over time; 2. To evaluate dosimetry of \[99mTc\]Tc-DARPinEc1-G3C in breast cancer patients; 3. To obtain initial information concerning safety and tolerability of \[99mTc\]Tc-DARPinEc1-G3C in breast cancer patients after single intravenous injection: The secondary objective are: 1\. To compare the tumour imaging data with \[99mTc\]Tc-DARPinEc1-G3C in breast cancer patients with Triple negative and Luminal subtypes.

Official title: SPECT/CT Imaging of Epithelial Cell Adhesion Molecule (EpCam) Expression in Triple Negative and Luminal Breast Cancer Using Technicium-99m-labelled Designed Ankyrin Repeat Proteins Ec1-G3C ([99mTc]Tc-DARPinEc1-G3C)

Key Details

Gender

FEMALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-06-22

Completion Date

2028-08-01

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

DRUG

[99mTc]Tc-DARPinEc1-G3C

One single injection of \[99mTc\]Tc-DARPinEc1-G3C, followed by gamma camera imaging directly postinjection and after 2, 4, 6, 24 and 48 hours.

Locations (1)

Russia Tomsk NRMC

Tomsk, Tomsk Reg, Russia