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Enrolling by invitation

NCT Number: NCT07784660

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

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.

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Key information

Conditions

Primary Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Russia Tomsk NRMC

Tomsk, Tomsk Reg, 634050, Russia

About this study

Overall goal of the project: To determine EpCam expression in primary breast cancer before any system therapy.

Phase I. Distribution of [99mTc]Tc-DARPinEc1-G3C in patients with primary breast cancer. The study should evaluate distribution of [99mTc]Tc-DARPinEc1-G3C in patients with primary Triple negative and Luminal breast cancer before treatment.

Methodology: Open-label, exploratory, single center study. The subjects will receive a single injection of the labelled tracer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is > 18 years of age
  • Morphological verification of Breast Cancer T2-4N0-3M0-1
  • Negative HER2 expression in primary tumour tissue according ASCO/CAP 2023 recommendation
  • ECOG 0-2.
  • 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

Exclusion criteria

  • Refusal from the study
  • Any system/local treatment
  • Second, non-breast malignancy
  • Active current autoimmune/infection disease or history of autoimmune disease. Known HIV positive or chronically active hepatitis B or C
  • Administration of other investigational medicinal product within 30 days of screening
  • Pregnancy
  • Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's

Treatment and study plan

[99mTc]Tc-DARPinEc1-G3C

Drug

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

Other names: SPECT

Primary outcomes

  1. Gamma camera-based whole-body [99mTc]Tc-DARPinEc1-G3C uptake value (percent)

    Time frame: 6 hours

    Whole-body [99mTc]Tc-DARPinEc1-G3C uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical.

  2. SPECT-based [99mTc]Tc-DARPinEc1-G3C uptake value in tumor lesions (counts)

    Time frame: 6 hours

    [99mTc]Tc-DARPinEc1-G3C uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts.

  3. SPECT-based [99mTc]Tc-DARPinEc1-G3C background uptake value (counts)

    Time frame: 6 hours

    Focal uptake of [99mTc]Tc-DARPinEc1-G3C in the regions without pathological findings will be assessed with SPECT and measured in counts

  4. Tumor-to-background ratio (SPECT)

    Time frame: 6 hours

    The SPECT-based tumor-to-background ratio will be calculated as follows: the value of [99mTc]Tc-DARPinEc1-G3C uptake coinciding with tumor lesions (counts) will be divided by the value of [99mTc]Tc-DARPinEc1-G3C uptake coinciding with the regions without pathological findings (counts)

Secondary outcomes

  1. Percent of cases with abnormal findings based on the assessments of physical examination relative to baseline

    Time frame: 48 hours

    The safety attributable to [99mTc]Tc-DARPinEc1-G3C injections will be evaluated based on the assessments of physical examination (percent of cases with abnormal findings relative to baseline)

  2. Percent of cases with abnormal findings based on the assessments of vital signs relative to baseline

    Time frame: 48 hours

    The safety attributable to [99mTc]Tc-DARPinEc1-G3C injections will be evaluated based on the assessments of vital signs (percent of cases with abnormal findings relative to baseline)

  3. Rate of adverse events (percent)

    Time frame: 48 hours

    The safety attributable to [99mTc]Tc-DARPinEc1-G3C injections will be evaluated based on the rate of adverse events (percent)

  4. Rate of administration of concomitant medication (percent)

    Time frame: 48 hours

    The safety attributable to [99mTc]Tc-DARPinEc1-G3C injections will be evaluated based on the rate of administration of concomitant medication (percent)

Sponsors and collaborators

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Other

Registry information

Official study 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)

Acronym: EpCam-Scan

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 25, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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