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

24. august 2026 opdateret af: Tomsk National Research Medical Center of the Russian Academy of Sciences

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)

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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

10

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Rusland
    • Tomsk Reg
      • Tomsk, Tomsk Reg, Rusland, 634050
        • Russia Tomsk NRMC

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Subject is > 18 years of age
  2. Morphological verification of Breast Cancer T2-4N0-3M0-1
  3. Negative HER2 expression in primary tumour tissue according ASCO/CAP 2023 recommendation
  4. ECOG 0-2.
  5. 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
  6. Subject is capable to undergo the diagnostic investigations to be performed in the study
  7. Informed consent

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: One single injection of [99mTc]Tc-DARPinEc1-G3C

A single injected dose of 3000 µg of [99mTc]Tc-DARPinEc1-G3C will be evaluated. The study requires enrollment of at least five (5) evaluable subjects per pathology cohort (Triple negative breast cancer and Luminal breast cancer).

Subjects withdrawn from the study for any reason will be replaced.
Medicin: [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.
Andre navne:
  • SPECT

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
SPECT-based [99mTc]Tc-DARPinEc1-G3C uptake value in tumor lesions (counts)
Tidsramme: 6 hours
[99mTc]Tc-DARPinEc1-G3C uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts.
6 hours
SPECT-based [99mTc]Tc-DARPinEc1-G3C background uptake value (counts)
Tidsramme: 6 hours
Focal uptake of [99mTc]Tc-DARPinEc1-G3C in the regions without pathological findings will be assessed with SPECT and measured in counts
6 hours
Tumor-to-background ratio (SPECT)
Tidsramme: 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)
6 hours
Gamma camera-based whole-body [99mTc]Tc-DARPinEc1-G3C uptake value (percent)
Tidsramme: 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.
6 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent of cases with abnormal findings based on the assessments of physical examination relative to baseline
Tidsramme: 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)
48 hours
Percent of cases with abnormal findings based on the assessments of vital signs relative to baseline
Tidsramme: 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)
48 hours
Rate of adverse events (percent)
Tidsramme: 48 hours
The safety attributable to [99mTc]Tc-DARPinEc1-G3C injections will be evaluated based on the rate of adverse events (percent)
48 hours
Rate of administration of concomitant medication (percent)
Tidsramme: 48 hours
The safety attributable to [99mTc]Tc-DARPinEc1-G3C injections will be evaluated based on the rate of administration of concomitant medication (percent)
48 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Efterforskere

  • Ledende efterforsker: Vladimir I. Chernov, Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. juni 2026

Primær færdiggørelse (Anslået)

1. august 2028

Studieafslutning (Anslået)

1. august 2028

Datoer for studieregistrering

Først indsendt

20. august 2026

Først indsendt, der opfyldte QC-kriterier

20. august 2026

Først opslået (Faktiske)

25. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. august 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ORI-2026.09.06

Plan for individuelle deltagerdata (IPD)

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