Evaluation of the utility of a novel 18F-FAPI-74 PET scan targeting cancer-associated fibroblasts (CAFs) in pancreatic cancer.

JRCT ID: jRCTs031240241

Registered date:30/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pancreatic cancer
• Date of first enrollment: 30/07/2024
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Interventional studies using unapproved radiopharmaceuticals to perform imaging examinations

Outcome(s)

• Primary Outcome: Ability to detect the main lesion (primary lesion) of pancreatic cancer compared to conventional imaging examinations

Secondary Outcome

18F-FAPI PET scan ability to detect the main lesion of pancreatic cancer (primary lesion) compared to FDG PET scan
Detection of metastatic foci of pancreatic cancer compared to FDG-PET scan
Detection of pancreatic cancer metastasis compared to conventional imaging
Correlation of immunohistologic evaluation of fibrosis and FAP in surgical specimens
Correlation between 18F-FAPI PET uptake (SUV value) and blood tumor markers
Correlation of 18F-FAPI PET accumulation (SUV value) with molecular biological analysis of surgical specimens

Key inclusion & exclusion criteria

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

Include criteria

1) Patients with high suspicion of pancreatic cancer based on comprehensive imaging and pathologic evaluation.
2) Patients whose maximum diameter of suspected pancreatic cancer is less than 2.5 cm, as comprehensively assessed by imaging (CT/MRI/US).
3) Patients diagnosed at a stage where pancreatectomy can be planned without distant metastases.
4) Patients with a Karnofsky Performance Status (KPS) of 70 or higher.
5) Patients who are at least 18 years of age at the time of consent.
(6) Patients who have been fully informed about the study and who have provided written informed consent.

Exclude criteria

1) Patients with serious cardiovascular disease
2) Patients with serious respiratory disease
3) Patients with serious hepatic disease (AST (GOT) or ALT (GPT) > 100 U/L)
4) Patients with serious renal disease (BUN > 25 mg/dL or serum creatinine > 2.0 mg/dL)
5) Women who are pregnant or have the possibility or desire to become pregnant
6) Women in the lactation period
7) Patients undergoing treatment for upper abdominal malignancies, or patients with a history of treatment for upper abdominal malignancies
8) Patients with phenylketonuria
9) Other patients who are deemed inappropriate as subjects by the principal investigator (subinvestigator).

Related Information

• Primary Sponsor: Oda Tatsuya
• Source(s) of Monetary Support: University of Tsukuba Hospital