68-Ga-FAPI PET Imaging in Malignancy

August 9, 2024 updated by: Stanford University

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Withdrawn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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 24 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Carina A Mari, MD, Stanford Universiy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe