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Clinical Trials in Japan / NCT05442151
Recruiting Not applicable

Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts

NCT05442151 · tracked via the Priya Life Science Japan tracker
Sponsor
Tadashi Watabe
Phase
Not applicable
Started
2022-05-09
Last updated
2025-07-31

Condition(s) studied

Neoplasms

Investigational drug(s) / intervention(s)

PET/CT ([F-18]FAPI-74)

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

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
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.

Primary outcome measure(s)

  • 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).)
  • 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

Trial sites (1)

FacilityCityRegionStatus
Osaka University Hospital Suita Osaka Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05442151 on ClinicalTrials.gov ↗ ← All trials in Japan