[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

March 25, 2026 updated by: Blue Earth Diagnostics

A Phase 1/2 Study of [18F]FPyQCP for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

71

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Contact:
          • Steven Rowe, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.
  2. Participants must be ≥ 18 years and < 80 years of age and competent to give informed consent.
  3. Eastern Cooperative Oncology Group performance status ≤ 2.
  4. 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).
  5. Women of childbearing potential (WOCBP) should have a negative serum test at screening (Visit 1) and a negative urine pregnancy test at the PET/CT imaging visit (Visit 2) prior to [18F]FPyQCP administration.
  6. WOCBP, and men who are sexually active with WOCBP, must agree to use a highly effective method(s) of contraception for the duration of the study
  7. Cohort A specific: Participants with stage I-III (see Appendix 3) CRC, GC, PDAC, ILC, or EOC (stage IV disease is allowed in the setting of oligometastatic disease [5 or fewer known metastases) as assessed by conventional imaging within 8 weeks of [18F]FPyQCP administration.
  8. Cohort B specific: Conventional imaging performed within 8 weeks of screening and no later than 24 hours before [18F]FPyQCP administration and available for upload to the central imaging vendor, including, at a minimum, a contrast-enhanced CT that includes the abdomen and pelvis.

  9. Either:

    1. Treatment-naïve with at least stage IIB disease. Available biopsy sample or scheduled biopsy or surgical resection no later than Day 42.
    2. Following neoadjuvant therapy (with at least stage IIB disease at initial presentation) with scheduled biopsy or surgical resection no later than Day 42. [18F]FPyQCP PET/CT imaging should be performed as close to scheduled procedure as clinically feasible.
    3. Suspected recurrence after definitive therapy

Exclusion Criteria:

  1. Participants administered any radioisotope within 5 physical half-lives prior to [18F]FPyQCP administration.
  2. Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to [18F]FPyQCP administration.
  3. Participants who have recently received any other contrast agent (< 24 hours for intravenous agents and < 5 days for oral agents) before the day of [18F]FPyQCP administration.
  4. Participants with a history of severe claustrophobia or panic attacks when in confined spaces.
  5. Known hypersensitivity to [18F]FPyQCP or any of its constituents.
  6. Participants with any medical condition or other circumstances at screening or in their past medical history that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or study completion.
  7. Known diagnosis of an autoimmune or inflammatory disorder that is expected to confound image interpretation per investigator judgment, excluding disorders directly related to the index cancer (e.g. tumor-associated pancreatitis or biliary stasis for PDAC).
  8. Medical history of abdomino-pelvic or breast irradiation in the last 3 months.
  9. Presence of any current implanted foreign material (e.g. stents, surgical clips) that may confound image interpretation per investigator judgment.
  10. Significant renal or hepatic impairment.
  11. Female participants who are breastfeeding, unless the participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the [18F]FPyQCP administration.
  12. Cohort A Specific Exclusion Criteria: No prior history of any other cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [18F]FPyQCP PET/CT
Each participant will receive [18F]FPyQCP followed by positron emission tomography (PET)/computed tomography (CT) imaging at the PET/CT imaging visit (Visit 2)
Drug: [18F]FPyQCP
positron emission tomography (PET)/computed tomography (CT) imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess radiation dosimetry of [18F]FPyQCP (Cohort A)
Time Frame: Up to 360 minutes post injection
Whole body effective dose of a single dose of [18F]FPyQCP
Up to 360 minutes post injection
Assess the diagnostic performance of [18F]FPyQCP in the peritoneum (Cohort B)
Time Frame: Until completion of follow-up procedures, up to 42 days post injection
Sensitivity and specificity of [18F]FPyQCP PET/CT compared to composite standard of truth
Until completion of follow-up procedures, up to 42 days post injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of adverse events using CTCAE version 5.0 (Both Cohorts)
Time Frame: From screening until safety follow-up (48 hours post injection)
Purpose is to evaluate the safety and tolerability of [18F]FPyQCP
From screening until safety follow-up (48 hours post injection)
Further assess the diagnostic performance of [18F]FPyQCP (Cohort B).
Time Frame: Until completion of follow-up procedures, up to 42 days post injection
Participant and region level diagnostic performance (where calculable: sensitivity, specificity, positive predictive value, and negative predictive value) with [18F]FPyQCP PET/CT compared to composite SOT and participant and region level detection rates.
Until completion of follow-up procedures, up to 42 days post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blue Earth Diagnostics

Collaborators

Medpace, Inc.

Investigators

  • Principal Investigator: Steven Rowe, MD, University of Texas Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BED-FAP-121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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