18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection
NCT Number: NCT06503146
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pancreatic Ductal Adenocarcinoma|Cholangiocarcinoma|Gastric Cancer|Bladder Cancer|Hepatocellular Carcinoma|Pheochromocytoma|Ovarian Cancer
Interventions: DRUG: [18F]FAPI-74|DRUG: [18F]FDG
Sponsor: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Allocation: NA|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-10
Completion Date: 2030-06-01
Locations: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States

Summary:
Background:

Fibroblast-activation protein (FAP) is an enzyme that appears in high numbers in certain cancer cells. \[18F\]FAPI-74 is a new tracer-a substance that is injected into a person s body before an imaging scan. Researchers believe that \[18F\]FAPI-74 may be able to highlight FAP enzymes more effectively than 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 scans are as good or better than other methods for detecting certain cancers.

Eligibility:

People aged 18 years or older with cancer in 1 of these places: the ducts of the pancreas, liver, gallbladder, or small intestine; stomach; bladder; ovaries; or adrenal glands. They must be enrolled in an NIH treatment study for their cancer.

Design:

Participants will have 2 baseline scans: 1 with \[18F\]FAPI-74; 1 with an approved tracer.

The \[18F\]FAPI-74 will be infused through a tube attached to a needle inserted into a vein. About 1 hour later, the participant will undergo 1 or more imaging scans.

Within 1 week, participants will undergo the same scanning procedures with the approved tracer.

If the baseline scan with \[18F\]FAPI-74 shows the tumors, scans with this tracer will be repeated when their regular treatment regimen calls for scans again. If the scans with the regular tracer also showed tumors, this scan will be repeated within the same week as the repeated \[18F\]FAPI-74 scans. If either type of scan showed no tumors, that scan will not be repeated.

If the participant s cancer progresses within 2 years, both types of scan may be repeated.

Follow-up calls will continue for 2 years.

Primary Outcome Measures: Mean number of lesions, The mean number of lesions detected will be compared between the different scan modalities for each cancer type., Baseline, post-treatment and recurrence
Secondary Outcome Measures: Standardized uptake value, For \[18F\]FAPI-74 PET imaging positive participants who undergo treatment, the change in \[18F\]FAPI-74 PET imaging uptake (SUV) between treatment will be compared by paired signed-rank Wilcoxon test. Response to treatment evaluated by \[18F\]FAPI-74 PET imaging will be compared with a response based on RECIST 1.1 and 18F-FDG PET by Fisher s exact test., Baseline, post-treatment and recurrence|Safety of [18F]FAPI 74 PET imaging, Safety will be evaluated by determining the frequency of adverse events among participants and reporting the results, by maximum grade of event and type of toxicity noted., [18F]FAPI-74 injection through 3 business days post injection.