Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts

• Sponsor: Tadashi Watabe (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05442151
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 22.7
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Drug: PET/CT ([F-18]FAPI-74)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts
• Actual Study Start Date: May 9, 2022
• Anticipated Primary Completion Date: Mar 31, 2024
• Anticipated Study Completion Date: Mar 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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).)

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Osaka University Hospital	Suita	Osaka	Japan	565-0871

Sponsors and Collaborators

• Tadashi Watabe

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tadashi Watabe, Assistant Professor, Osaka University
• ClinicalTrials.gov Identifier: NCT05442151
• Other Study ID Numbers: 21472
• First Posted: Jul 1, 2022
• Last Update Posted: Jul 1, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 1, 2022