The Role of 68Ga-FAPI-04 PET/CT as a Problem Solving Imaging Modality in Various Malignancies

Study Overview
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Brief Summary
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The aim of the suggested study is to assess the added value of 68Ga-FAPI-04 PET/CT over 18F-FDG PET/CT in evaluating the extent of disease in patients with various malignancies, in whom a diagnostic challenge is met, such as inconclusive findings on 18F-FDG PET/CT or other imaging studies, better delineation of tumor extent prior to therapy, and with emphasis on malignancies known to show variable avidity to FDG and at times, no uptake at all. Also patients unable to optimally comply with the required preparation for FDG imaging, such as diabetic patients who struggle in achieving glycemic control.

Official Title
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The Role of 68Ga-FAPI-04 PET/CT as a Problem Solving Imaging Modality in Various Malignancies

Conditions
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Different Types of Cancer

Intervention / Treatment
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* Radiation: 68Ga-FAPI-04 PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The study population will include up to 50 patients with disease in whom a diagnostic challenge is met, including but not limited to: Inconclusive findings on 18F-FDG PET/CT or other imaging modalities. Better delineation of tumor extent prior to therapy Malignancies known to show variable avidity to FDG and at times, no uptake at all (e.g. Exocrine Pancreatic cancer, Gastric carcinoma, Mucin-producing or Signet-ring carcinoma). Patients unable to optimally comply with the required preparation for FDG imaging. The study population will include only patients treated in Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel, and referred by their attending physicians, of whom are part of the hospital staff. Exclusion Criteria: Age < 18 years. Pregnant females. Patients who are reluctant to undergo both FDG and FAPI PET scans.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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: Different types of cancer<br>The study population will include up to 50 patients with disease in whom a diagnostic challenge is met, including but not limited to: Inconclusive findings on 18F-FDG PET/CT or other imaging modalities. Better delineation of tumor extent prior to therapy Malignancies known to show variable avidity to FDG and at times, no uptake at all (e.g. Exocrine Pancreatic cancer, Gastric carcinoma, Mucin-producing or Signet-ring carcinoma). Patients unable to optimally comply with the required preparation for FDG imaging. The study population will include only patients treated in Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel, and referred by their attending physicians, of whom are part of the hospital staff. | Radiation: 68Ga-FAPI-04 PET/CT<br>* Patients will undergo two scans: first a routine FDG PET scan and a FAPI PET scan, within 10 days. Scans will be interpreted by board certified Nuclear medicine physicians and board certified radiologists. Immunohistochemical analysis with specific staining for FAP will be performed in removed malignant tissues, either at surgery or from biopsy, to assess a possible correlation between the intensity of uptake and the level of FAP expression.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients who preformed 68Ga-FAPI-04 PSMA. | To evaluate the avidity of various cancers to 68Ga-FAPI-04. | 1 year | 
| Patients who preformed 68Ga-FAPI-04 PSMA and PET/CT FDG. | To compare the detectability of FAPI-04 and FDG for malignant lesions. | 1 year | 
| Patients who preformed 68Ga-FAPI-04 PSMA and PET/MRI. | To evaluate the potential impact of 68Ga-FAPI-04 PET/CT and/or PET/MRI on patient management. | 1 year |