AI-assisted 4D PET imaging to detect early pancreatic cancer lesions
Official title: Artificial Intelligence-Assisted 4D Dynamic Long-Axial PET Imaging for the Detection of Early Pancreatic Cancer Lesions
Run by Ruijin Hospital · NCT07925125 · Data updated 2026-11-12
This study tests whether AI-assisted 4D long-axial PET imaging with FDG and FAPI can help detect early PDAC lesions in patients with suspected pancreatic tumors.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | November 15, 2024 |
| Main results expected | December 31, 2028 |
| Study ends | July 31, 2029 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07925125 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with suspected pancreatic tumors larger than 1 cm and no prior histopathological diagnosis.
✕Probably not a fit
Patients whose lesions are not detected by the AI-assisted imaging or who do not have malignant disease may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will perform whole-body PET/CT scans using 18F-FDG and 68Ga-FAPI, along with four-dimensional dynamic long-axial imaging, to visualize early pancreatic lesions from metabolic, fibrotic, and receptor-expression perspectives. An AI tool will assist in detecting and characterizing lesions and distinguishing benign from malignant findings. Imaging results will be compared with postoperative histopathology to measure diagnostic performance. The study is observational and will enroll adults with suspected pancreatic tumors who have not yet received a histopathological diagnosis.
Why it matters
Potential benefit: If successful, the approach could improve early detection and diagnostic accuracy for pancreatic cancer.
How similar studies have gone: Prior studies suggest multimodal PET imaging and AI-assisted detection can improve lesion characterization, though this exact 4D long-axial AI approach is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with suspected pancreatic tumors larger than 1.0 cm. * No histopathological diagnosis available before enrollment. * No prior treatment for the suspected pancreatic tumor. * Histopathological diagnosis obtained through surgery or biopsy within 2 months after PET imaging. * Able and willing to provide written informed consent. * Willing and able to comply with the study procedures and follow-up requirements. * Male or female, aged 18-75 years. * In generally good health, with an estimated life expectancy of more than 6 months and able to tolerate the imaging procedures. Exclusion Criteria: * Severe concomitant diseases that, in the investigator's judgment, make participation in the study inappropriate, including severe cardiopulmonary dysfunction or severe hepatic or renal impairment. * Pregnancy, suspected pregnancy, or breastfeeding. * Poor compliance with the study procedures.
Where it's running
-
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China Recruiting
Study contacts
- Study coordinator: Li
- Email: lb10363@rjh.com.cn
- Phone: 0086-021-64370045
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.