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NCT06503146 · ClinicalTrials.gov registry record · Phase 2
18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection
A Phase 2 study of Ovarian Cancer and Bladder Cancer, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 320
- Enrollment target
- 1
- Study location
NCT06503146 is a Phase 2 study of Ovarian Cancer and Bladder Cancer that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 320 participants, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06503146, a Phase 2 study of Ovarian Cancer and Bladder Cancer, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 320 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Fibroblast-activation protein (FAP) is an enzyme that appears in high numbers in cancer-associated fibroblasts of certain cancer types. \[18F\]FAPI-74 is a new PET (positron emission tomography) tracer, a substance that is injected into a person s body before an imaging scan. Researchers believe that \[18F\]FAPI-74 PET imaging may be able to visualize cancer more effectively than the approved tracers. If so, the new tracer would make it easier to find FAP-positive tumors in the body. Objective: To see if \[18F\]FAPI-74 PET scan is as good or better than other imaging methods for detecting certain cancers. Eligibility: People aged 18 years or older with one of these cancer types: pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, hepatocellular carcinoma (HCC), gastric cancer, bladder cancer, ovarian cancer, pheochromocytoma/paraganglioma (PPGL), small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancer (EP-NEC), mesothelioma or sarcoma. Participants must be scheduled or intended to receive treatment for cancer. Design: Participants will have 2 baseline scans: an \[18F\]FAPI-74, and the approved tracer \[18F\]-FDG. The \[18F\]FAPI-74 will be infused through a needle inserted into a vein. About 1 hour later, the participant will undergo imaging. Within 1 week, participants will undergo the same scanning procedures with the approved tracer. If the baseline scan with \[18F\]FAPI-74 shows the tumor(s), scans with this tracer will be repeated when their regular treatment regimen calls for scans again. If the scan with the regular FDG also show tumors, this scan will be repeated within the same week as the repeated \[18F\]FAPI-74 scan. If \[18F\]-FAPi PET scan shows no tumor(s), scans will not be repeated. If the participant's cancer progresses within 2 years, scans may be repeated. Follow-up calls will continue for 2 years.
Conditions Studied
Interventions
- DRUG [18F]FAPI-74
- DRUG [18F]FDG
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2025-09-09 |
| Est. Completion | 2030-06-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06503146
The ClinicalTrials.gov registry entry for NCT06503146 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (56% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions - of which [18F]FAPI-74 is the first listed.
NCT06503146 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06503146 about?
NCT06503146 is a clinical study titled "18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection". Background: Fibroblast-activation protein (FAP) is an enzyme that appears in high numbers in cancer-associated fibroblasts of certain cancer types. \[18F\]FAPI-74 is a new PET (positron emission tomography) tracer, a substance that is injected into a person s body before an imaging scan. Researcher...
What is the current status of trial NCT06503146?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 320 participants. The study started on 2025-09-09. Estimated completion is 2030-06-01.
What conditions does trial NCT06503146 study?
This clinical trial studies the following conditions: Ovarian Cancer, Bladder Cancer, Gastric Cancer, Hepatocellular Carcinoma, Sarcoma.
What interventions are being tested in trial NCT06503146?
The interventions under investigation include: [18F]FAPI-74 (DRUG), [18F]FDG (DRUG).
Who is sponsoring clinical trial NCT06503146?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06503146 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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