Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts

Study Overview
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Brief Summary
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PET / CT examination using [18F] FAPI-74 is performed on patients diagnosed with malignant tumor, and the pathological condition is determined by comparing with FDG-PET/CT examination of conventional diagnostic imaging.

Detailed Description
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Cancer stroma accounts for more than 90% of all tumors, and cancer-related fibroblasts (CAFs) play an important role in the growth and progression of cancer. FAP expressed in CAF has been found to be expressed in many cancers, and [68Ga] FAPI-04 and [18F] FAPI-74, which are PET diagnostic agents for FAP ligand FAPI, have been used all over the world. The purpose of this study is to perform PET / CT using [18F] FAPI-74 injection for patients diagnosed with malignant tumors, mainly pancreatic cancer and gastric cancer to evaluate the pathology in detail by comparing with the FDG-PET/CT.

Official Title
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Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: PET/CT ([F-18]FAPI-74)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who meet any of the following conditions. Patients who have been diagnosed with malignant tumors or suspected of having malignant tumors and have CT or FDG-PET examination. Patients who have been diagnosed with malignant tumor and are scheduled to receive or have undergone anticancer treatment such as chemotherapy or radiation therapy. Patients suspected of recurrence by clinical findings or diagnostic imaging such as CT or FDG-PET after treatment of malignant tumor Exclusion Criteria: Pregnant women or patients who may be pregnant Pediatric patients requiring sedation Those who are judged to be inappropriate as subjects.
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 |
| --- | --- |
| Other: FAPI-PET/CT group<br> | Drug: PET/CT ([F-18]FAPI-74)<br>* PET/CT using [18F] FAPI-74 injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the uptake on FAPI-PET with conventional imaging | Comparison of SUV (standardized uptake value) of primary site and metastatic lesions between FAPI-PET and FDG-PET | Within 2 hours after administration of [F-18]FAPI-74 injection | 
| Comparison with pathological specimens | Comparison of expression level (staining score) in FAP immunostaining and SUV in FAPI-PET (FAP staining is graded by scoring evaluation: high expression (3 points), moderate expression (2 points), mild expression (1 point), and no significant expression (0 point).) | Within one month after FAPI-PET | 
| Time course of uptake on FAPI-PET | Time course of uptake on FAPI-PET before and after treatment compared with conventional imaging | Approximately 6 months after initial FAPI-PET |