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

JRCT ID: jRCTs031240615

Registered date:16/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Lung cancer, liver cancer, other cancers
• Date of first enrollment: 16/01/2025
• Target sample size: 30
• Study type: Other
• Intervention(s): 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 (within 3 months before irradiation) and after the end of radiotherapy (4 months after the end of irradiation and around 1 year after the end of irradiation). 18F-FAPI-74-PET/CT will be performed at the same time as standard imaging studies in each disease, The ability of standard imaging tests and 18F-FAPI-74-PET/CT to detect foci will be compared.

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Sakurai Hideyuki