Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms
• Intervention / Treatment: Drug: PET/CT ([F-18]FAPI-74)

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tadashi Watabe, M.D., Ph.D.; Phone Number: +81-6-6879-3461; Email: watabe@tracer.med.osaka-u.ac.jp

Study Locations

• Japan
  • Osaka
    • Suita, Osaka, Japan, 565-0871
      • Recruiting
      • Osaka University Hospital
      • Contact: Tadashi Watabe, M.D., Ph.D.; Phone Number: +81-6-6879-3461; Email: watabe@tracer.med.osaka-u.ac.jp
      • Principal Investigator: Tadashi Watabe, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: FAPI-PET/CT group	Drug: PET/CT ([F-18]FAPI-74); PET/CT using [18F] FAPI-74 injection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tadashi Watabe

Publications and helpful links

General Publications

• Naka S, Watabe T, Lindner T, Cardinale J, Kurimoto K, Moore M, Tatsumi M, Mori Y, Shimosegawa E, Valla F Jr, Kato H, Giesel FL. One-pot and one-step automated radio-synthesis of [18F]AlF-FAPI-74 using a multi purpose synthesizer: a proof-of-concept experiment. EJNMMI Radiopharm Chem. 2021 Aug 21;6(1):28. doi: 10.1186/s41181-021-00142-z.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: June 18, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 21472

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No