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Study on a new PET diagnostic method using 18F-FAPI-74

A study on a novel PET diagnostic method using 18F-FAPI-74 targeting tumor-associated fibroblasts (CAFs) for pre-diagnosis and efficacy evaluation of radiotherapy

Status
Recruiting
Phases
Phase 2
Study type
Unknown
Source
JPRN
Registry ID
JPRN-jRCTs031240615
Enrollment
30
Registered
2025-01-16
Start date
2025-06-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer, liver cancer, other cancers

Interventions

The study is designed as an open-label, uncontrolled, single-arm comparison. The study objective is diagnostic. Radiotherapy patients will undergo 18F-FAPI-74-PET/CT before the start of radiotherapy (
Radiation therapy, proton therapy, FAPI-PET, FDG-PET

Sponsors

Sakurai Hideyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria are eligible (1) Cancer patients with grossly visible lesions of 1 cm or more in diameter in the following (A) - (C), which can be confirmed by diagnostic imaging (A) Liver cancer (B) Lung cancer (C) Other cancers (2) Patients scheduled to receive radiotherapy (X-ray therapy or proton beam therapy) (3) Patients who are 18 years of age or older (at the time of obtaining consent) and whose free and voluntary consent can be obtained (4) Patients whose prognosis after radiotherapy is expected by the principal investigator and the subinvestigator to be more than 1 year.

Exclusion criteria

Exclusion criteria: (1) Patients who are scheduled to start a new treatment for cancer other than radiotherapy during the study period. (2) Patients with serious cardiovascular, respiratory, renal, gastrointestinal, hematological, neurological, psychiatric, or collagen diseases. (3) Pregnant and lactating patients. (4) Patients who do not meet the following general laboratory criteria.(Blood sampling tests are performed within 3 months) (1) AST (GOT) and ALT (GPT) less than 2.5 times the upper limit of institutional normal (2) Total bilirubin less than 1.5 times the upper limit of institutional normal (3) Albumin greater than 2 g/dL (4) Creatinine is 1.5 times or less than the upper limit of institutional normal, or creatinine clearance is 60 mL/min or more. (5) Other patients deemed inappropriate by the physician in charge.

Design outcomes

Primary

MeasureTime frame
Detectability of foci by 18F-FAPI-74-PET prior to initiation of radiotherapy (staging) Determination of efficacy after radiotherapy Judgment by two study physicians. Each will be evaluated in 5 steps.

Secondary

MeasureTime frame
Detectability of lesions by 18F-FAPI-74-PET after radiotherapy (efficacy determination) SUVmax, Tumor-to-Background ratio

Contacts

Public ContactMasashi Mizumoto

University of Tsukuba Hospital

mizumoto@pmrc.tsukuba.ac.jp+81-29-853-7100

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026