Actively Recruiting
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
Led by Blue Earth Diagnostics · Updated on 2026-03-27
71
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
Sponsors
B
Blue Earth Diagnostics
Lead Sponsor
M
Medpace, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of \[18F\]FPyQCP in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).
CONDITIONS
Official Title
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must give informed consent and agree to follow all study procedures.
- Age between 18 and 79 years and able to provide informed consent.
- Eastern Cooperative Oncology Group performance status of 2 or less.
- Diagnosis of colorectal, gastric, pancreatic ductal adenocarcinoma, invasive lobular breast, or epithelial ovarian cancer confirmed or suspected by pathology.
- Women of childbearing potential must have a negative pregnancy test before imaging.
- Women of childbearing potential and sexually active men must use effective contraception during the study.
- Cohort A: Stage I-III or oligometastatic stage IV disease confirmed by imaging within 8 weeks prior to imaging.
- Cohort B: Recent conventional imaging including contrast-enhanced CT of abdomen and pelvis within 8 weeks before and 24 hours prior to imaging.
- Participants must be treatment-naive with at least stage IIB disease and have a biopsy or scheduled surgery within 42 days, or have completed neoadjuvant therapy with scheduled biopsy or surgery within 42 days, or have suspected recurrence after definitive therapy.
You will not qualify if you...
- Received any radioisotope within 5 physical half-lives before study imaging.
- Received any other investigational medicinal product within 2 weeks or 5 half-lives before study imaging.
- Received any contrast agent within 24 hours (intravenous) or 5 days (oral) before study imaging.
- History of severe claustrophobia or panic attacks in confined spaces.
- Known allergy to [18F]FPyQCP or its components.
- Any medical condition or history that may interfere with study data or completion.
- Diagnosed autoimmune or inflammatory disorders that could affect image interpretation, except those related to the index cancer.
- Abdomino-pelvic or breast radiation therapy within the last 3 months.
- Presence of implanted foreign materials that may affect image interpretation.
- Significant kidney or liver impairment.
- Breastfeeding women who do not commit to pumping and discarding breast milk for at least 24 hours after study imaging.
- For Cohort A: any prior history of other cancers.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
J
Jamie MacKay, MD, PhD
CONTACT
E
Evgenia Perkins
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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