Recruiting
Phase 1
Phase 2

\[18F\]FPyQCP

Sponsor:

Blue Earth Diagnostics

Code:

NCT07432633

Conditions

Colorectal Cancer

Epithelial Ovarian Cancer

Gastric Cancer

Invasive Lobular Breast Carcinoma

Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

[18F]FPyQCP

Study Details

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).

Conditions

Colorectal Cancer

Epithelial Ovarian Cancer

Gastric Cancer

Invasive Lobular Breast Carcinoma

Pancreatic Ductal Adenocarcinoma

Study ID

NCT07432633

Start date

Feb 19, 2026

Status verified date

Jun, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

71 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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)

Interventions

[18F]FPyQCP

positron emission tomography (PET)/computed tomography (CT) imaging

Primary outcome measure

  • Assess radiation dosimetry of [18F]FPyQCP (Cohort A) [ Time Frame: 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 ]

Central Contacts and Locations

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

More Information

Sponsor

Blue Earth Diagnostics

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Positron emission tomography
  • Fibroblast activation protein

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Blue Earth Diagnostics on 2026-06-23.