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NCT Number: NCT06849063

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

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shengjing hospital of China medical university

Shenyang, Liaoning, 110004, China

Location status: Recruiting

Location contact

Yu Shi, MD.PhD.

CONTACT

[email protected]

18940259980

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Magnetic Resonance Imaging

Diagnostic Test

all participants undergo novel MR sequences, including 3D MRE#DCE-MRI#IVIM-DWI#T1/T2 mapping.

Other names: MR elastrogaphy

Primary outcomes

  1. Analyzing the measurement accuracy of MRE.

    Time frame: 9 months

    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.

  2. Radiological assessment of tumor stiffness

    Time frame: 9 months

    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).

  3. Evaluation of tumor response to chemotherapy.

    Time frame: 12 months

    RECIST criteria (version 1.1) were used to objectively evaluate the response to chemotherapy.

  4. Investigating the correlation between magnetic resonance elastography (MRE) shear stiffness and clinical outcomes in pancreatic cancer patients.

    Time frame: 9 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Hong, MD.PhD.

CONTACT

[email protected]

18940259080

Yu Shi, MD.PhD.

CONTACT

[email protected]

18940259980

Sponsors and collaborators

Lead sponsor

Yu Shi

Other

Registry information

Official study title

3D-MRE-Based Evaluation of Biomechanical Heterogeneity in Pancreatic Cancer and Its Clinical Prognosis

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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