68-Ga-FAPI PET Imaging in Malignancy

Cancer Clinical Trial

Official title:

68Ga-FAPI PET Imaging in Malignancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04023240
• Other study ID #: IRB-52129
• Secondary ID: VAR0195
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2023
• Est. completion date: December 14, 2023

Study information

• Verified date: May 2023
• Source: Stanford University
• Contact: Risa Jiron
• Phone: 650-736-1598
• Email: rjiron[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 14, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patient with current malignancy confirmed via pathology or imaging

• Patient must be > 18 years old

• Patient must be willing and able to provide written informed consent for the trial

• Patient of reproductive potential will have a pregnancy test

Exclusion Criteria:

• Pregnant or breastfeeding

Related Conditions & MeSH terms

• Cancer
• Neoplasms

Intervention

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.
• Positron Emission Tomography (PET) scan
PET images will be acquired.

Locations

Country	Name	City	State
United States	Stanford University Hospitals and Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of 68Ga-FAPI PET	Feasibility of 68Ga-FAPI PET/CT imaging will be done to assess patients with malignancy. Feasibility will be measured using Likert scale (1-non diagnostic; 5-excellent; anything 3 or more is diagnostic). The study will be feasible if > 50% of scans will have a score of 3 or more	24 months