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Exploratory clinical trial to evaluate the efficacy and safety of FAPI-PET for diffuse gastric cancer

Exploratory clinical trial to evaluate the efficacy and safety of FAPI-PET for diffuse gastric cancer - FAPI diffuse gastric cancer (FAPI-DGC) Study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031250386
Enrollment
20
Registered
2025-09-24
Start date
2025-11-18
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

Diffuse gastric cance (poorly differentiated adenocarcinoma) gastric cancer, poorly differentiated, diffuse, scirrhous, signet-ring cell

Interventions

Sponsors

Akashi Yoshimasa
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria are eligible for this study. 1) Patients diagnosed with gastric cancer based on upper gastrointestinal endoscopy and pathological tissue biopsy 2) Patients with low-differentiated adenocarcinoma (por, por1, por2) or signet ring cell carcinoma (sig) components detected in preoperative tissue biopsy 3) Patients undergoing curative surgery for gastric cancer or diagnostic laparoscopy 4) Patients aged 18 years or older at the time of informed consent 5) Patients who have received adequate explanation regarding participation in this trial, demonstrated sufficient understanding, and provided written informed consent of their own free will.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria shall not be included in this trial. 1) Patients with a history of gastrectomy and residual gastric cancer 2) Patients with severe renal disease (BUN >=25 mg/dL or serum creatinine >=2.0 mg/dL) 3) Pregnant women or women who may be pregnant or wish to become pregnant 4) Women who are breastfeeding 5) Patients with phenylketonuria 6) Other patients deemed ineligible for participation by the principal investigator or co-investigator.

Design outcomes

Primary

MeasureTime frame
The accuracy rate of preoperative staging diagnosis (T-, N-, and M- staging) for conventional examination alone or FAPI-PET added diagnosis.

Secondary

MeasureTime frame
Detection rate of 18F-FAPI-PET examination for primary gastric cancer lesions Detection rate of 18F-FAPI-PET examination for metastatic gastric cancer lesions Accuracy rate of primary tumour progression diagnosis in gastric cancer Correlation between fibrosis and FAP immunohistochemical evaluation in surgical resection specimens Correlation between 18F-FAPI-PET uptake (SUV values) and blood tumour markers Ability to distinguish tumour uptake from non-tumour uptake using early and delayed phase imaging

Contacts

Public ContactYoshimasa Akashi

University of Tsukuba Hospital

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

Outcome results

None listed

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