MRE for Diagnosis of Pancreatic Masses
MREDPCM
Experimental and Clinical Study of Three-dimensional Magnetic Resonance Elastography to Evaluate Pancreatic Cancer and Interstitial Fibrosis
1 other identifier
observational
200
1 country
1
Brief Summary
Pancreatic ductal adenocarcinoma (PDAC) accounts for 85-95% of pancreatic cancer and is one of the deadliest tumors in the world, with a survival rate of less than 8%, and identifying key prognostic or predictive factors facilitates risk stratification and prospective assessment in clinical trials. The extracellular matrix (ECM) surrounding PDAC often exhibits a large number of interstitial fibrosis, which is closely related to the formation, development and metastasis of PDAC. High order three-dimensional MR elastography (3D-MRE) allows non-invasive measurements of sheer stiffness in normal pancreas and pancreatic lesions. However, there are no reports about the application of MRE imaging biomarkers to predict the prognosis of PDAC at home and abroad.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 9, 2020
CompletedFirst Submitted
Initial submission to the registry
July 17, 2024
CompletedFirst Posted
Study publicly available on registry
July 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
February 13, 2026
December 1, 2025
5.8 years
July 17, 2024
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Analyzing the measurement accuracy of MRE.
The hardness was measured by a hardness tester during the operation, and the mechanical parameters were measured by atomic force microscopy of the in vitro specimen. The measurement accuracy of MRE was analyzed by comparing the hardness tester and atomic force microscope results.
9 months
Radiological assessment of tumor stiffness.
A self-written script program in MATLAB is used to read and analyze mechanical group diagrams and waveform diagrams in three directions of x, y, and z, and a region of interest (ROI) delineation function is embedded.After drawing the ROI, an Excel file containing the corresponding values is automatically generated, and the average values of various mechanical parameters are calculated, including shear modulus (\|G\*\|, SS), storage modulus (G', SM), loss modulus (G'', LM) and damping ratio (ӡ, DR).
9 months
Evaluation of tumor response to chemotherapy.
RECIST criteria (version 1.1) were used to objectively evaluate the response to chemotherapy.
12 months
Study Arms (2)
Plan to include patients with resectable pancreatic cancer 150
Investigators anticipate that 150 resectable pancreatic cancer participants are enrolled in this group and all participants undego magnetic resonance imaging.
Plan to include patients with unresectable pancreatic cancer 50
Investigators anticipate that 50 unresectable pancreatic cancer participants are enrolled in this group and all participants undego magnetic resonance imaging.
Interventions
all participants undergo novel MR sequences, including 3D-MRE，DCE-MRI，IVIM-DWI，T1/T2 mapping.
Eligibility Criteria
participants aged 18-80 years
You may qualify if:
- granting of written informed consent
- age ≥18 years
- no history of extrapancreatic malignancy
- no preoperative biliary drainage
- definitive histologic evidence of PDAC in excisional biopsy
- with no less than three months of postoperative mortality or six months of follow- up
You may not qualify if:
- inability to re-review of tissue specimens
- unacceptable estimates of MRE parameters, specifically invalid wave data during postprocessing, inconsistent breath-holdings, intolerable pain, and MRE hardware disconnection
- tumor diameters \<1.0 cm
- withdrawal/dropout during follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yu Shilead
Study Sites (1)
Shengjing hospital of china medical university
Shenyang, Liaoning, 110004, China
Related Publications (1)
Yang A, Gu C, Liu Y, Luo B, Zeng Y, Zhou M, Li C, Pan C, Wu L, Hu Z, Zhang X, Gao F, Shi Y. ITGB5-mediated biomechanical regulation in pancreatic ductal adenocarcinoma stroma impacts tumor progression and prognosis. J Transl Med. 2025 Oct 21;23(1):1150. doi: 10.1186/s12967-025-07119-5.
PMID: 41121153DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu Shi, MD.PhD.
Shengjing Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 17, 2024
First Posted
July 29, 2024
Study Start
October 9, 2020
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
February 13, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share