Actively Recruiting
Phase 2 Study Evaluating 68GaBED003 PET Imaging for Detecting Fibroblast Activation Protein in Colorectal, Gastric, Pancreatic, Breast, and Ovarian Cancers
Led by Blue Earth Diagnostics · Updated on 2026-07-15
65
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Blue Earth Diagnostics
Lead Sponsor
M
Medpace, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of 68GaBED003, a diagnostic imaging agent, in detecting multiple types of cancer including colorectal, gastric, pancreatic ductal adenocarcinoma, invasive lobular breast carcinoma, and epithelial ovarian cancer. This Phase 2, open-label, single-arm study aims to assess how well 68GaBED003 performs in identifying these cancers through imaging techniques. Each participant will receive an injection of 68GaBED003 followed by positron emission tomography PETcomputed tomography CT scans during the imaging visit. The study includes a screening period, the imaging procedure, and a brief safety follow-up. The main focus is on the diagnostic accuracy of 68GaBED003, including tumor uptake and optimal imaging timing and dosage. Participants will undergo screening to confirm eligibility, including performance status and pregnancy testing for women of childbearing potential. They will receive the imaging agent and have PETCT scans at the imaging visit. Safety and tolerability are monitored up to 48 hours after injection, with follow-up assessments up to 42 days. The study measures how well 68GaBED003 detects cancer in the peritoneum and other sites, with the entire participation lasting a few weeks around the imaging and follow-up visits.
CONDITIONS
Brief Title
[68Ga]BED003 PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants provide informed consent and agree to follow the study requirements.
- Participants are aged 18 to less than 80 years and able to give informed consent.
- Eastern Cooperative Oncology Group performance status of 2 or less.
- Women of childbearing potential must have negative serum and urine pregnancy tests as required.
- Women of childbearing potential and men with partners in this group must agree to use effective contraception during the study period.
- Diagnosis of colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, invasive lobular breast carcinoma, or epithelial ovarian cancer.
- Conventional imaging including contrast-enhanced CT of abdomen and pelvis performed within 8 weeks before screening and within 24 hours before imaging agent administration.
- Either treatment-naïve with at least stage IIB disease and available biopsy or scheduled surgery by Day 42, post-neoadjuvant therapy with scheduled biopsy or surgery by Day 42, or suspected recurrence after definitive therapy.
You will not qualify if you...
- Participants who received any radioisotope within 5 physical half-lives before imaging agent administration.
- Participants who received any other investigational medical product within 2 weeks or 5 half-lives before imaging agent administration.
- Recent use of contrast agents within 24 hours for IV agents or 5 days for oral agents before imaging agent administration.
- History of severe claustrophobia or panic attacks in confined spaces.
- Known allergy to [68Ga]BED003 or its components.
- Medical conditions or history that may affect data reliability or study completion, including other primary cancers, recent major surgery within 3 months, serious wounds or fractures, active hepatitis, significant recent cardiac disorders.
- Diagnosed autoimmune or inflammatory disorders expected to interfere with image interpretation, excluding those related to the cancer.
- Medical history of abdomino-pelvic or breast radiation in the last 3 months.
- Presence of implanted foreign material that may interfere with imaging.
- Significant kidney impairment defined by specific laboratory criteria.
- Breastfeeding women unless committed to discard breast milk from imaging visit to safety follow-up.
Research Team
J
Jamie MacKay
J
Jason Kane
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