Clinical trial NCT06849063: Assessment of the Prognosis of Pancreatic Cancer Patients Using 3D MRE
Official title: 3D-MRE-Based Evaluation of Biomechanical Heterogeneity in Pancreatic Cancer and Its Clinical Prognosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer,
Magnetic Resonance Elastography
Prognosis
Biomechanics
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants aged 18-80 years

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.

Detailed description: 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

Primary outcomes:
measure: Analyzing the measurement accuracy of MRE.
timeFrame: 9 months
measure: Radiological assessment of tumor stiffness
timeFrame: 9 months
measure: Evaluation of tumor response to chemotherapy.
timeFrame: 12 months
measure: Investigating the correlation between magnetic resonance elastography (MRE) shear stiffness and clinical outcomes in pancreatic cancer patients.
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing hospital of China medical university
state: Liaoning
Study officials:
affiliation: Study Principal Investigator
name: Yu Shi, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References: