Actively Recruiting
A Phase 1/2 Study of [18F]FPyQCP for 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
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 studying a new imaging agent called [18F]FPyQCP in a Phase 1/2 trial to evaluate its safety, radiation exposure, and how well it detects several cancers: colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, invasive lobular breast cancer, and epithelial ovarian cancer. This study involves multiple centers and aims to provide preliminary diagnostic information on these conditions using advanced imaging techniques. Participants in this study will receive an injection of [18F]FPyQCP followed by a positron emission tomography (PET)/computed tomography (CT) scan during a designated imaging visit. The study includes two groups: Cohort A focuses on radiation dosimetry up to 360 minutes post-injection, and Cohort B evaluates diagnostic performance over a follow-up period of up to 42 days. Women of childbearing potential and sexually active men must use effective contraception during the study. During the trial, participants will undergo various assessments including imaging scans, safety monitoring for adverse events from screening through 48 hours after injection, and follow-up procedures to assess diagnostic accuracy. Researchers will carefully measure radiation exposure and imaging results to determine how well [18F]FPyQCP identifies cancer presence. The study runs until January 2028, with participants monitored closely to ensure safety and gather comprehensive data.
CONDITIONS
Brief Title
[18F]FPyQCP 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 protocol
- Aged 18 years or older and younger than 80 years
- Eastern Cooperative Oncology Group performance status of 2 or less
- Diagnosed with colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, invasive lobular breast cancer, or epithelial ovarian cancer (confirmed or suspected)
- Women of childbearing potential must have negative pregnancy tests at screening and before imaging
- Women of childbearing potential and sexually active men agree to use effective contraception during the study
- Cohort A: Stage I-III cancer or stage IV with five or fewer known metastases confirmed by imaging within 8 weeks before imaging
- Cohort B: Recent conventional imaging including contrast-enhanced CT of abdomen and pelvis within 8 weeks before screening and 24 hours before imaging
- Treatment-na�ve with at least stage IIB disease or post-neoadjuvant therapy with scheduled biopsy or surgery within 42 days, or suspected recurrence after therapy
You will not qualify if you...
- Received any radioisotope within five physical half-lives prior to imaging
- Received any other investigational medicinal product within two weeks or five half-lives before imaging
- Recent use of contrast agents within 24 hours (intravenous) or 5 days (oral) before imaging day
- History of severe claustrophobia or panic attacks in confined spaces
- Known allergy to [18F]FPyQCP or its components
- Medical conditions or history that may affect data reliability or study completion
- Autoimmune or inflammatory disorders that could interfere with imaging interpretation
- Abdomino-pelvic or breast radiation therapy within the last 3 months
- Current implanted foreign materials that may affect imaging
- Significant kidney or liver impairment
- Breastfeeding women unless willing to discard milk for at least 24 hours after imaging
- Cohort A: Prior history of any other cancer not allowed during screening period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 360 minutes post injection for Cohort A; up to 42 days post injection for Cohort B
Participants receive the [18F]FPyQCP injection followed by PET/CT imaging to assess fibroblast activation protein in selected oncology indications.
1 imaging visit (in-person)
Duration - Up to 42 days post injection
Participants are monitored for safety and diagnostic performance after imaging, including assessment of adverse events.
Safety follow-up visit within 48 hours post injection and additional assessments up to 42 days
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
E
Evgenia Perkins
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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