68-Ga-FAPI PET Imaging in Malignancy

68Ga-FAPI PET Imaging in Malignancy

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.

Study Overview

• Status: Withdrawn
• Conditions: Cancer
• Intervention / Treatment: Drug: 68Ga-FAPI; Procedure: Computed Tomography (CT) scan; Procedure: Positron Emission Tomography (PET) scan

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 68Ga-FAPI PET/CT; Patients receive 68Ga-FAPI IV and then undergo PET/CT approximately 1 hour later.

Drug: 68Ga-FAPI; 68Ga-FAPI is quinoline based PET radiopharmaceutical. 68Ga-FAPI is administered intravenously (IV); Other Names: 68-Ga-Fibroblast activation protein inhibitor (FAPI); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Carina A Mari, MD, Stanford Universiy

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): July 14, 2023
• Study Completion (Estimated): December 14, 2023

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IRB-52129; VAR0195 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No