RecruitingPhase 2interventionalRules rewrite

Phase 2: testing [18F]FAPI-74 for Sarcoma

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.

Official registry: https://clinicaltrials.gov/study/NCT06503146 · National Cancer Institute (NCI) · enrollment listed as 320

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are [18F]FAPI-74, or [18F]FDG. The registry lists allocation as na. Background: Fibroblast-activation protein (FAP) is an enzyme that appears in high numbers in cancer-associated fibroblasts of certain cancer types.

They plan to enroll about 320 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection

Interventions: [18F]FAPI-74, [18F]FDG

Primary outcome (registry wording): Mean number of lesions

Who it is for (from inclusion criteria)

Ages 18 Years to 120 Years
Participants must be scheduled or intended to receive treatment for their cancer
Eastern Cooperative Oncology Group (ECOG) performance score \<= 2
Must be willing to discontinue breastfeeding for 2 months after each study imaging

Who the registry excludes

History of allergic reactions attributed to compounds of similar chemical or biologic composition to \[18F\]FAPI-74 or other agents used in the study
History of severe claustrophobia unresponsive to oral anxiolytics or history of any other condition preventing the ability to lie on the imaging scanner for up to 45 minutes
Weight \> 350 lbs., or inability to fit within the imaging gantry
Positive Beta-human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in IOCBP at screening
Serum creatinine \> 2 times the upper limit of normal
Liver transaminases (ALT, AST) greater than 3 times the upper limit of normal

Public study contact (from the registry)

Yolanda L McKinney, R.N.

(240) 760-6095

ymckinney@mail.nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

National Institutes of Health Clinical Center — Bethesda, Maryland (recruiting)

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FAQ about this NCT record

Is NCT06503146 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06503146?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06503146?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary