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68-Ga-FAPI PET Imaging in Malignancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04023240
Recruitment Status : Not yet recruiting
First Posted : July 17, 2019
Last Update Posted : May 25, 2023
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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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
Cancer 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : July 2023
Estimated Primary Completion Date : July 14, 2023
Estimated Study Completion Date : December 14, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023240


Contacts
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Contact: Risa Jiron 650-736-1598 rjiron@stanford.edu

Locations
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United States, California
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Carina A Mari, MD Stanford Universiy
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04023240    
Other Study ID Numbers: IRB-52129
VAR0195 ( Other Identifier: OnCore )
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: May 25, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Neoplasms