PET scan using [18F]FPyQCP to image fibroblast activation protein in several cancers

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

This test tries a new PET imaging tracer, [18F]FPyQCP, to see if it helps detect colorectal, gastric, pancreatic ductal adenocarcinoma, invasive lobular breast, and epithelial ovarian cancers in adults.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 71 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Blue Earth Diagnostics (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT07432633 on ClinicalTrials.gov

What this trial studies

This is an open-label, single-arm Phase 1/2 imaging protocol that administers the investigational PET tracer [18F]FPyQCP to adults with selected solid tumors to collect safety data, radiation dosimetry, and preliminary diagnostic performance. Participants will undergo PET/CT imaging following tracer administration, with enrollment targeting patients with confirmed colorectal, gastric, pancreatic ductal adenocarcinoma, invasive lobular breast, or epithelial ovarian cancer. The trial emphasizes safety monitoring and image-based detection metrics rather than therapeutic interventions. Initial cohorts include earlier-stage disease (stage I-III) for certain indications to characterize tracer uptake across disease stages.

Who should consider this trial

Good fit: Adults aged 18–79 with confirmed colorectal, gastric, pancreatic ductal adenocarcinoma, invasive lobular breast, or epithelial ovarian cancer, ECOG performance status ≤2, able to give informed consent, and meeting pregnancy/contraception requirements are the intended candidates.

Not a fit: People who are pregnant, under 18 or over 79, have poor performance status, have cancer types outside the listed indications, or are unable/unwilling to undergo PET/CT imaging are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the tracer could improve tumor detection and localization by highlighting fibroblast activation protein, potentially improving staging and treatment planning.

How similar studies have performed: Other FAP-targeted PET tracers (FAPI agents) have shown promising tumor uptake and diagnostic performance in multiple cancers, so this approach builds on encouraging early results though [18F]FPyQCP itself is a newer compound.

Eligibility criteria

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.

Where this trial is running

Dallas, Texas

• University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Steven Rowe, MD — University of Texas Southwestern Medical Center
• Study coordinator: Jamie MacKay, MD, PhD

Conditions Colorectal Cancer; Epithelial Ovarian Cancer; Gastric Cancer; Invasive Lobular Breast Carcinoma; Pancreatic Ductal Adenocarcinoma; Positron emission tomography; Fibroblast activation protein