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

Last updated: February 23, 2025
Sponsor: Yu Shi
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatic Cancer

Pancreatitis

Pancreatic Disorders

Treatment

magnetic resonance imaging

Clinical Study ID

NCT06849063
ShengjingH-chem-PDAC
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. inability to re-review of tissue specimens

  2. unacceptable estimates of MRE parameters, specifically invalid wave data duringpostprocessing, inconsistent breath-holdings, intolerable pain, and MRE hardwaredisconnection

  3. tumor diameters <1.0 cm

  4. withdrawal/dropout during follow-up

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: magnetic resonance imaging
Phase:
Study Start date:
October 09, 2020
Estimated Completion Date:
December 01, 2026

Study 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.

Connect with a study center

  • Shengjing hospital of China medical university

    Shenyang, Liaoning 110004
    China

    Active - Recruiting

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