68-Ga-FAPI PET Imaging in Malignancy
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|ClinicalTrials.gov Identifier: NCT04023240|
Recruitment Status : Not yet recruiting
First Posted : July 17, 2019
Last Update Posted : May 25, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: 68Ga-FAPI Procedure: Computed Tomography (CT) scan Procedure: Positron Emission Tomography (PET) scan||Phase 2|
To assess feasibility and biodistribution of PET imaging in malignancy using 68Ga-FAPI.
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: 68Ga-FAPI PET/CT
Patients receive 68Ga-FAPI IV and then undergo PET/CT approximately 1 hour later.
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.
- 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
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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|
- 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
- Pregnant or breastfeeding
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
|Contact: Risa Jironfirstname.lastname@example.org|
|United States, California|
|Stanford University Hospitals and Clinics|
|Stanford, California, United States, 94305|
|Principal Investigator:||Carina A Mari, MD||Stanford Universiy|
|Responsible Party:||Stanford University|
|Other Study ID Numbers:||
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|
|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|