Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts

Neoplasms Clinical Trial

Official title:

Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05442151
• Other study ID #: 21472
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2024
• Source: Osaka University
• Contact: Tadashi Watabe, M.D., Ph.D.
• Phone: +81-6-6879-3461
• Email: watabe[@]tracer.med.osaka-u.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• PET/CT ([F-18]FAPI-74)
PET/CT using [18F] FAPI-74 injection

Locations

Country	Name	City	State
Japan	Osaka University Hospital	Suita	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Tadashi Watabe

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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 experi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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