Study on Using [18F]FAPI-74 PET Imaging for Detecting Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT06503146

Provider View

This clinical trial is testing a new imaging tracer, [18F]FAPI-74, to see if it can better detect certain cancers compared to current methods. The study involves patients with specific types of cancer who are already part of an NIH treatment study.

Patient Parameters

Program Overview

The study aims to find out if a new imaging tracer, [18F]FAPI-74, can highlight cancer cells more effectively than current tracers. This tracer is injected into the body before a scan and may help identify tumors that have high levels of a specific enzyme. The goal is to see if [18F]FAPI-74 PET scans are as good or better than other imaging methods for detecting certain cancers.

Description

This study focuses on a new imaging technique using [18F]FAPI-74, a tracer that targets a specific enzyme found in many cancer cells. This enzyme, called fibroblast-activation protein (FAP), is often present in high amounts in cancerous tissues. The tracer is injected into the body and helps highlight these areas during a PET scan, potentially making it easier to detect tumors.

Participants will undergo two initial scans: one with the new [18F]FAPI-74 tracer and another with a standard tracer. If the new tracer shows the tumors, it will be used again during future scans as part of the participant's regular treatment schedule. If the standard tracer also shows tumors, it will be repeated alongside the [18F]FAPI-74 scans. If neither scan shows tumors, they will not be repeated unless the cancer progresses within two years.

The study will follow participants for two years, with regular check-ins to monitor their health and any changes in their cancer. This research could lead to better imaging techniques for detecting and monitoring cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of specific types of cancer, such as pancreatic, liver, stomach, bladder, ovarian, or certain other cancers.
  • Must be part of an NIH cancer treatment study.
  • Must be 18 years or older.
  • Must be in relatively good health, with a performance status score of 2 or less.
  • Must agree to use effective birth control during the study and for two months after each imaging session.
  • Must be willing to stop breastfeeding for two months after each imaging session.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • History of allergic reactions to similar compounds as [18F]FAPI-74.
  • Severe claustrophobia or other conditions that prevent lying still for up to 45 minutes during a scan.
  • Weight over 350 lbs or inability to fit in the imaging machine.
  • Positive pregnancy test.
  • Uncontrolled medical conditions that could interfere with the study or increase risk.
  • High levels of creatinine or liver enzymes in the blood.

Locations

FACILITYZIPCITYSTATE
National Institutes of Health Clinical Center20892BethesdaMaryland

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