NCT07432633 [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
| NCT ID | NCT07432633 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Blue Earth Diagnostics |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 71 participants |
| Start Date | 2026-02-19 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 71 participants in total. It began in 2026-02-19 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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: 12. No prior history of any other cancer, unless treated with curative-intent and disease-free for at least 5 years before Visit 1 (at least 1 year before Visit 1 for basal cell carcinoma, localized squamous cell carcinoma of the skin and in situ carcinoma of cervix).
Contact & Investigator
Steven Rowe, MD
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT07432633 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07432633 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07432633 currently recruiting?
Yes, NCT07432633 is actively recruiting participants. Contact the research team at jamie.mackay@blueearthdx.com for enrollment information.
Where is the NCT07432633 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT07432633 clinical trial?
NCT07432633 is sponsored by Blue Earth Diagnostics. The principal investigator is Steven Rowe, MD at University of Texas Southwestern Medical Center. The trial plans to enroll 71 participants.
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