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

ConditionPancreatic Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorYu Shi

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

granting of written informed consent

age ≥18 years

no history of extrapancreatic malignancy

no preoperative biliary drainage

Disqualifiers

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

Trial population

participants aged 18-80 years

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • magnetic resonance imaging

    Diagnostic test

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: patients with resectable pancreatic cancer1 intervention
Group B: patients with unresectable pancreatic cancer1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
9 months
2

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).

Time frame
9 months
3

Evaluation of tumor response to chemotherapy.

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

Time frame
12 months
4

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.

Time frame
9 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yu Shi

Lead sponsor

Shengjing Hospital

Sponsor institution

Source ClinicalTrials.gov
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