Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 9, 2022
CompletedFirst Submitted
Initial submission to the registry
June 18, 2022
CompletedFirst Posted
Study publicly available on registry
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedJuly 31, 2025
July 1, 2025
3.9 years
June 18, 2022
July 28, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (1)
FAPI-PET/CT group
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant women or patients who may be pregnant
- Pediatric patients requiring sedation
- Those who are judged to be inappropriate as subjects.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tadashi Watabelead
Study Sites (1)
Osaka University Hospital
Suita, Osaka, 565-0871, Japan
Related 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 experiment. EJNMMI Radiopharm Chem. 2021 Aug 21;6(1):28. doi: 10.1186/s41181-021-00142-z.
PMID: 34420105BACKGROUND
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 18, 2022
First Posted
July 1, 2022
Study Start
May 9, 2022
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
July 31, 2025
Record last verified: 2025-07