NCT04023240

68-Ga-FAPI PET Imaging in Malignancy

68Ga-FAPI PET Imaging in Malignancy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 19 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This feasibility trial studies the use of gallium-68 (68Ga)-FAPI as the imaging agent for positron emission tomography (PET)/computed tomography (CT), collectively PET/CT, in patients with various cancers. PET uses a radioactive substance called 68Ga-FAPI, which attaches to cancer activated fibroblasts. The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy tissue. CT uses X-rays to make a picture of areas inside the body. Using 68Ga-FAPI in diagnostic procedures, such as PET/CT, may allow doctors to identify smaller tumors than standard imaging.

Detailed description

PRIMARY OBJECTIVE: To assess feasibility and biodistribution of PET imaging in malignancy using 68Ga-FAPI. OUTLINE: Patients receive 68Ga-FAPI intravenously (IV) and then undergo PET/CT approximately 1 hour later. After completion of study, patients are followed up at 24-72 hours.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	68Ga-FAPI	68Ga-FAPI is quinoline based PET radiopharmaceutical. 68Ga-FAPI is administered intravenously (IV)
PROCEDURE	Computed Tomography (CT) scan	Participants will have a CT scan for attenuation correction and anatomic localization of PET data.
PROCEDURE	Positron Emission Tomography (PET) scan	PET images will be acquired.

Timeline

• Start date: 2023-07-01
• Primary completion: 2023-07-14
• Completion: 2023-12-14
• First posted: 2019-07-17
• Last updated: 2024-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study