Pancreas CarcinomaNCT07925125
Artificial Intelligence-Assisted 4D Dynamic Long-Axial PET Imaging for the Detection of Early Pancreatic Cancer Lesions
An observational study of Pancreas Carcinoma and PDAC - Pancreatic Ductal Adenocarcinoma, run by Ruijin Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreas Carcinoma, PDAC - Pancreatic Ductal Adenocarcinoma
- What is being tested?
- PET/CT with 18F-FDG and 68Ga-FAPI
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2024to 31 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected pancreatic tumors treated at Ruijin Hospital
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
Li, 0086-021-64370045, lb10363@rjh.com.cn
About this study
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.
- Being tested
- PET/CT with 18F-FDG and 68Ga-FAPI
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT with 18F-FDG and 68Ga-FAPIDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: PET/CT with 18F-FDG and 68Ga-FAPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 2 months after PET imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start15 Nov 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CarcinomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Politecnico di Milano, University of Bern
- Responsible party
- Principal investigator, LI BIAO, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07925125
- Sponsor's protocol ID
- RuijinH 2024(338)
- Status last verified
- Nov 2026
- First submitted
- 3 Nov 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Assisted 4D Dynamic Long-Axial PET Imaging for the Detection of Early Pancreatic Cancer Lesions
- ClinicalTrials.gov ID
- NCT07925125
- Acronym / sponsor ID
- RuijinH 2024(338)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Politecnico di Milano, University of Bern
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 9 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Suspected Pancreatic Lesions | – | Diagnostic Test: PET/CT with 18F-FDG and 68Ga-FAPIParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected pancreatic tumors treated at Ruijin Hospital
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CT with 18F-FDG and 68Ga-FAPIRoutine 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. | Diagnostic test | Patients with Suspected Pancreatic Lesions |
Primary outcome
Diagnostic Performance of Dynamic PET Imaging for Pancreatic Lesion Characterization
Time frame: Within 2 months after PET imaging
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Carcinoma and PDAC - Pancreatic Ductal Adenocarcinoma, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li (0086-021-64370045, lb10363@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance of Dynamic PET Imaging for Pancreatic Lesion Characterization (time frame: Within 2 months after PET imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2026.