ClinicalTrials.gg
RecruitingNCT07925125Updated Nov 9, 2026

Artificial Intelligence-Assisted 4D Dynamic Long-Axial PET Imaging for the Detection of Early Pancreatic Cancer Lesions

An observational study in Pancreas Carcinoma and PDAC - Pancreatic Ductal Adenocarcinoma, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Ruijin Hospital · Observational

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 11 months later.
Updated Nov 9, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Pancreatic ductal adenocarcinoma (PDAC) is associated with a poor prognosis, and early detection of pancreatic lesions is of great importance for improving patient outcomes. In this study, whole-body imaging with FDG and FAPI will be used to visualize the early development of pancreatic cancer lesions from multiple perspectives, including glucose metabolism, tumor fibrotic stroma, and integrin receptor expression. Furthermore, leveraging the advantages of four-dimensional dynamic long-axial PET imaging, artificial intelligence-assisted lesion detection and analysis will be performed to characterize lesions and differentiate between benign and malignant lesions. The imaging findings will subsequently be compared with postoperative histopathological results to evaluate the diagnostic performance of the proposed imaging approaches.

02

Conditions studied

  • Pancreas Carcinoma
  • PDAC - Pancreatic Ductal Adenocarcinoma
03

In context

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.

This study's planned enrollment of 50 is below the median of 200 across 740 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 679 studies on the registry; 387 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with suspected pancreatic tumors treated at Ruijin Hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 within 2 months after PET imaging.
  • Able and willing to provide written .
  • 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 of more than 6 months and able to tolerate the imaging procedures.

Exclusion criteria

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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

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Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with Suspected Pancreatic Lesions

    Participants with suspected pancreatic lesions undergoing PET imaging will be enrolled in this prospective observational study. Imaging approaches may include FDG and FAPI PET, with four-dimensional dynamic long-axial PET imaging and artificial intelligence-assisted lesion detection and characterization. Imaging findings will be evaluated for lesion detection and benign-malignant differentiation and compared with postoperative histopathological results when available.

    Diagnostic Test: PET/CT with 18F-FDG and 68Ga-FAPI

Interventions

  • Diagnostic testPET/CT with 18F-FDG and 68Ga-FAPI

    Routine PET imaging performed as part of clinical care will be evaluated in this prospective observational study. Four-dimensional dynamic long-axial PET imaging and artificial intelligence-assisted image analysis will be used for pancreatic lesion detection and characterization, including differentiation between benign and malignant lesions. Imaging findings will be compared with histopathological results when available.

06

What researchers measure

Primary outcomes

  1. Diagnostic Performance of Dynamic PET Imaging for Pancreatic Lesion Characterization

    The diagnostic performance of 4D dynamic long-axial PET imaging combined with artificial intelligence-assisted lesion detection and analysis will be evaluated for the detection and differentiation of benign and malignant pancreatic lesions. Imaging findings will be compared with postoperative histopathological results as the reference standard

    Time frame: Within 2 months after PET imaging

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07925125
Lead sponsor
Ruijin Hospital
Collaborators
Politecnico di Milano, University of Bern
Responsible party
LI BIAO (Professor and Director of the Department of Nuclear Medicine, Ruijin Hospital) — Principal investigator
First posted
Nov 9, 2026
Start date
Nov 15, 2024
Primary completion
Dec 31, 2028 (estimated)
Completion
Jul 31, 2029 (estimated)
Last update
Nov 9, 2026

Study contacts

Li
Contact
lb10363@rjh.com.cn
0086-021-64370045

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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