TheranosticTrials.org
Blue Earth Diagnostics, LTD

Clinical Trial · NCT07702292

[68Ga]BED003 PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

Overview

This is a multi-centre, open-label, single-arm, Phase 2 study designed to evaluate the diagnostic performance of \[68Ga\]BED003 in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).

Sponsor

Blue Earth Diagnostics, LTD

Phase

Phase 2

Contacts

Jamie MacKay (CONTACT)

contact@blueearthdx.com

44 (0)1865 507300

Jason Kane (CONTACT)

contact@blueearthdx.com

44 (0)1865 507300

ClinicalTrials.gov

NCT07702292

Drug / Compound

BED003

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Chelator: DOTAGA

Eligibility

Inclusion

  • Treatment-naïve with at least stage IIB disease. Available biopsy sample or scheduled biopsy or surgical resection no later than Day 42. Cytology of the primary lesion is acceptable for participants with PDAC who are not surgical candidates.
  • Following neoadjuvant therapy (with at least stage IIB disease at initial presentation) with scheduled biopsy or surgical resection no later than Day 42.
  • Diagnosis of either CRC (confirmed by histopathology), GC (confirmed by histopathology), PDAC (confirmed by cytology or histopathology), ILC (confirmed by histopathology), or EOC (suspected or confirmed by cytology or histopathology). Note: Invasive breast cancer with mixed ductal/lobular histology is permitted.
  • Suspected recurrence after definitive therapy.

Exclusion

Exclusion criteria not yet provided.

Patient Education

Patient education not yet provided.

Publications

Publications not yet provided.

Locations

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