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

Sponsor
Blue Earth Diagnostics
Study ID
NCT07702292
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • [68Ga]BED003 — DRUG
    Positron emission tomography (PET)/computed tomography (CT) imaging

Study Details

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).

Key Dates

First listed
Jul 14, 2026
Start date
Jun 30, 2026
Status verified
Jul 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: [68Ga]BED003
    Each participant will receive \[68Ga\]BED003 followed by positron emission tomography (PET)/computed tomography (CT) imaging at the PET/CT imaging visit (Visit 2).

Primary Outcome Measure

Assess the diagnostic performance of [68Ga]BED003 in the peritoneum. [ Time Frame: Until completion of follow-up procedures, up to 42 days post injection. ]

Central Contacts

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