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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031240241
Enrollment
15
Registered
2024-07-30
Start date
2024-11-20
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

pancreatic cancer

Interventions

Sponsors

Oda Tatsuya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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).

Design outcomes

Primary

MeasureTime frame
Ability to detect the main lesion (primary lesion) of pancreatic cancer compared to conventional imaging examinations

Secondary

MeasureTime frame
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

Contacts

Public ContactMiyazaki Yoshihiro

University of Tsukuba Hospital

y-miyazaki@md.tsukuba.ac.jp+81-29-853-3221

Outcome results

None listed

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