68-Ga-FAPI PET Imaging in Malignancy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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68Ga-FAPI PET Imaging in Malignancy

Conditions
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Cancer

Intervention / Treatment
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* Drug: 68Ga-FAPI
* Procedure: Computed Tomography (CT) scan
* Procedure: Positron Emission Tomography (PET) scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-FAPI PET/CT<br>Patients receive 68Ga-FAPI IV and then undergo PET/CT approximately 1 hour later. | Drug: 68Ga-FAPI<br>* 68Ga-FAPI is quinoline based PET radiopharmaceutical. 68Ga-FAPI is administered intravenously (IV)<br>* Other names: 68-Ga-Fibroblast activation protein inhibitor (FAPI);Procedure: Computed Tomography (CT) scan<br>* Participants will have a CT scan for attenuation correction and anatomic localization of PET data.<br>Procedure: Positron Emission Tomography (PET) scan<br>* PET images will be acquired.<br>|

What is the study measuring?
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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 |