Molecular Imaging of EpCam Expression in Breast Cancer Using [99mTc]Tc-DARPinEc1-G3C (EpCam-Scan)
24 augusti 2026 uppdaterad av: 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:
- To assess distribution of [99mTc]Tc-DARPinEc1-G3C in normal tissues and in tumors over time;
- To evaluate dosimetry of [99mTc]Tc-DARPinEc1-G3C in breast cancer patients;
- 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.
Studieöversikt
Status
Anmälan via inbjudan
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
10
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Tomsk Reg
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Tomsk, Tomsk Reg, Ryssland, 634050
- Russia Tomsk NRMC
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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. |
One single injection of [99mTc]Tc-DARPinEc1-G3C, followed by gamma camera imaging directly postinjection and after 2, 4, 6, 24 and 48 hours.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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SPECT-based [99mTc]Tc-DARPinEc1-G3C uptake value in tumor lesions (counts)
Tidsram: 6 hours
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[99mTc]Tc-DARPinEc1-G3C uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts.
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6 hours
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SPECT-based [99mTc]Tc-DARPinEc1-G3C background uptake value (counts)
Tidsram: 6 hours
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Focal uptake of [99mTc]Tc-DARPinEc1-G3C in the regions without pathological findings will be assessed with SPECT and measured in counts
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6 hours
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Tumor-to-background ratio (SPECT)
Tidsram: 6 hours
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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)
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6 hours
|
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Gamma camera-based whole-body [99mTc]Tc-DARPinEc1-G3C uptake value (percent)
Tidsram: 6 hours
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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.
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6 hours
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percent of cases with abnormal findings based on the assessments of physical examination relative to baseline
Tidsram: 48 hours
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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)
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48 hours
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Percent of cases with abnormal findings based on the assessments of vital signs relative to baseline
Tidsram: 48 hours
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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)
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48 hours
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Rate of adverse events (percent)
Tidsram: 48 hours
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The safety attributable to [99mTc]Tc-DARPinEc1-G3C injections will be evaluated based on the rate of adverse events (percent)
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48 hours
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Rate of administration of concomitant medication (percent)
Tidsram: 48 hours
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The safety attributable to [99mTc]Tc-DARPinEc1-G3C injections will be evaluated based on the rate of administration of concomitant medication (percent)
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48 hours
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Vladimir I. Chernov, Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
22 juni 2026
Primärt slutförande (Beräknad)
1 augusti 2028
Avslutad studie (Beräknad)
1 augusti 2028
Studieregistreringsdatum
Först inskickad
20 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
20 augusti 2026
Första postat (Faktisk)
25 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 augusti 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ORI-2026.09.06
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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Nej
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Nej
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