Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts

Not Applicable

Recruiting

• Conditions: Neoplasms
• Interventions: Drug: PET/CT ([F-18]FAPI-74)

• Registration Number: NCT05442151
• Lead Sponsor: Tadashi Watabe

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-05-09
• Study First Submitted: 2022-06-18
• Study First Submitted QC: 2022-06-29
• Study First Posted: 2022-07-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patients who meet any of the following conditions.

1. Patients who have been diagnosed with malignant tumors or suspected of having malignant tumors and have CT or FDG-PET examination.
2. Patients who have been diagnosed with malignant tumor and are scheduled to receive or have undergone anticancer treatment such as chemotherapy or radiation therapy.
3. Patients suspected of recurrence by clinical findings or diagnostic imaging such as CT or FDG-PET after treatment of malignant tumor

Exclusion Criteria

1. Pregnant women or patients who may be pregnant
2. Pediatric patients requiring sedation
3. Those who are judged to be inappropriate as subjects.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FAPI-PET/CT group	PET/CT ([F-18]FAPI-74)	-

Primary Outcome Measures

Name	Time	Method
Time course of uptake on FAPI-PET	Approximately 6 months after initial FAPI-PET	Time course of uptake on FAPI-PET before and after treatment compared with conventional imaging
Comparison of the uptake on FAPI-PET with conventional imaging	Within 2 hours after administration of [F-18]FAPI-74 injection	Comparison of SUV (standardized uptake value) of primary site and metastatic lesions between FAPI-PET and FDG-PET
Comparison with pathological specimens	Within one month after FAPI-PET	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).)

Trial Locations

Locations (1)

Osaka University Hospital; 🇯🇵 Suita, Osaka, Japan