Assessment of the Prognosis of Pancreatic Cancer Patients Using 3D MRE
3D-MRE-Based Evaluation of Biomechanical Heterogeneity in Pancreatic Cancer and Its Clinical Prognosis
1 other identifier
observational
200
1 country
1
Brief Summary
Pancreatic ductal adenocarcinoma (PDAC), representing 85-95% of pancreatic cancers, is a highly lethal malignancy with a dismal 5-year survival rate below 8%. Emerging evidence highlights the critical need for non-invasive imaging biomarkers to stratify prognosis and guide therapeutic strategies. Notably, the biomechanical properties of PDAC-associated extracellular matrix (ECM), characterized by extensive interstitial fibrosis, are intrinsically linked to tumorigenesis, progression, and metastatic dissemination. Three-dimensional magnetic resonance elastography (3D-MRE), as an advanced imaging modality, enables precise quantification of tissue shear stiffness in both normal pancreatic parenchyma and neoplastic lesions. Significantly, the biomechanical heterogeneity captured by MRE holds untapped potential to serve as a prognostic biomarker for PDAC. Despite its technical merits, no studies to date have systematically explored MRE-derived imaging signatures in predicting PDAC survival outcomes or therapeutic responses, underscoring a pivotal gap in translational oncology research.
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 9, 2020
CompletedFirst Submitted
Initial submission to the registry
February 23, 2025
CompletedFirst Posted
Study publicly available on registry
February 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedFebruary 17, 2026
February 1, 2025
5.4 years
February 23, 2025
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 (#, 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
Investigating the correlation between magnetic resonance elastography (MRE) shear stiffness and clinical outcomes in pancreatic cancer patients.
Optimize longitudinal follow-up for pancreatic cancer patient subgroups. Utilizing shear stiffness measurements from magnetic resonance elastography (MRE) and clinical outcomes among distinct patient groups, generate Kaplan-Meier survival curves to determine the clinical utility of biomechanical characterization in prognosticating pancreatic cancer. Statistical analyses were conducted with R and GraphPad Prism.
9 months
Study Arms (2)
patients with resectable pancreatic cancer
Investigators anticipate that 150 resectable pancreatic cancer participants are enrolled in this group and all participants undego magnetic resonance imaging
patients with unresectable pancreatic cancer
Investigators anticipate that 50 unresectable pancreatic cancer participants are enrolled in this group and all participants undego magnetic resonance imagin.
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu Shi, MD.PhD.
Study Principal Investigator
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
February 23, 2025
First Posted
February 27, 2025
Study Start
October 9, 2020
Primary Completion
March 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
February 17, 2026
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share