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

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

• Sarcoma
• Small Cell Lung Cancer or Extrapulmonary Neuroendocrine Cancer (EP-NEC)
• Mesothelioma
• Pheochromocytoma/Paraganglioma (PPGL)
• Pancreatic Ductal Adenocarcinoma
• Ovarian Cancer
• Hepatocellular Carcinoma
• Gastric Cancer
• Cholangiocarcinoma
• Bladder Cancer

Interventions

DRUG

[18F]FAPI-74

Participants will receive a single intravenous (IV) dose of \[18F\]FAPI-74 prior to PET/CT imaging.

DRUG

[18F]FDG

18F-FDG PET/CT or PET/MRI imaging will be done per standard of care.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Esther Mena Gonzalez, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-09

Primary Completion

2028-06-01

Completion

2030-06-01

FDA Drug

Yes

Countries

• United States

Study Locations