TrialPath
Recruiting

Assessment of the Prognosis of Pancreatic Cancer Patients Using 3D MRE

NCT06849063 · Shengjing Hospital
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
3D-MRE-Based Evaluation of Biomechanical Heterogeneity in Pancreatic Cancer and Its Clinical Prognosis
About this study
Pancreatic ductal adenocarcinoma (PDAC), constituting 85-95% of pancreatic cancers, ranks among the most lethal malignancies globally, with a dismal 5-year survival rate below 8%. Identifying robust prognostic or predictive biomarkers is critical for risk stratification and prospective therapeutic evaluation in clinical trials. The extracellular matrix (ECM) surrounding PDAC is characterized by extensive interstitial fibrosis, a pathological hallmark intrinsically linked to tumor initiation, progression, and metastatic dissemination. While the ECM exerts dual roles in modulating cancer biology through multifaceted mechanisms, compelling experimental evidence confirms that ECM stiffening in PDAC accelerates tumor aggressiveness and correlates significantly with reduced patient survival. Noninvasive quantification of tumor mechanical properties (e.g., stiffness) prior to treatment could provide critical insights into tumor biology, prognostic stratification, and personalized therapeutic decision-making. Advanced three-dimensional magnetic resonance elastography (3D-MRE) enables precise, noninvasive mapping of shear stiffness across both healthy pancreatic tissue and neoplastic lesions. Despite its technical promise, the translational potential of MRE-derived imaging biomarkers for predicting PDAC prognosis remains unexplored, with no systematic studies reported domestically or internationally to date.
Eligibility criteria
Inclusion Criteria: 1. granting of written informed consent 2. age ≥18 years 3. no history of extrapancreatic malignancy 4. no preoperative biliary drainage 5. definitive histologic evidence of PDAC in excisional biopsy 6. with no less than three months of postoperative mortality or six months of follow- up Exclusion Criteria: 1. inability to re-review of tissue specimens 2. unacceptable estimates of MRE parameters, specifically invalid wave data during postprocessing, inconsistent breath-holdings, intolerable pain, and MRE hardware disconnection 3. tumor diameters \<1.0 cm 4. withdrawal/dropout during follow-up
Study design
Enrollment target: 200 participants
Age groups: adult, older_adult
Timeline
Starts: 2020-10-09
Estimated completion: 2026-12-01
Last updated: 2026-02-17
Interventions
Diagnostic Test: magnetic resonance imaging
Primary outcomes
  • Analyzing the measurement accuracy of MRE. (9 months)
  • Radiological assessment of tumor stiffness (9 months)
  • Evaluation of tumor response to chemotherapy. (12 months)
Sponsor
Yu Shi · other
Contacts & investigators
ContactYu Shi, MD.PhD. · contact · 18940259980@163.com · 18940259980
ContactYang Hong, MD.PhD. · contact · hongyangcmu@hotmail.com · 18940259080
InvestigatorYu Shi, MD.PhD. · principal_investigator, Study Principal Investigator
All locations (1)
Shengjing hospital of China medical universityRecruiting
Shenyang, Liaoning, China
Assessment of the Prognosis of Pancreatic Cancer Patients Using 3D MRE · TrialPath