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68-Ga-FAPI PET Imaging in Malignancy

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04023240
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
9.5
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 68Ga-FAPI
  • Procedure: Computed Tomography (CT) scan
  • Procedure: Positron Emission Tomography (PET) scan
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
68Ga-FAPI PET Imaging in Malignancy
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Jul 14, 2022
Anticipated Study Completion Date :
Dec 14, 2022

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of 68Ga-FAPI PET [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Hospitals and Clinics Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stanford University
    ClinicalTrials.gov Identifier:
    NCT04023240
    Other Study ID Numbers:
    • IRB-52129
    • VAR0195
    First Posted:
    Jul 17, 2019
    Last Update Posted:
    Jan 25, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Jan 25, 2022