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

Study acronym: EpCam-Scan
StatusEnrolling by Invitation
PhasePhase 1
Started
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Record History

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  1. Notable Primary endpoint(s) modified
    • Secondary endpoints revised (4)
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07784660
Lead Sponsor Tomsk National Research Medical Center of the Russian Academy of Sciences
Conditions
(from sponsor)
Primary Breast Cancer
Related terms Breast Neoplasms
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov