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Recruiting NCT06526442

MRE for Diagnosis of Pancreatic Masses

Observational Pancreatic Neoplasm Magnetic Resonance Imaging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: magnetic resonance imaging.
Who it may be relevant to
Registry conditions: Pancreatic Neoplasm, Magnetic Resonance Imaging. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Experimental and Clinical Study of Three-dimensional Magnetic Resonance Elastography to Evaluate Pancreatic Cancer and Interstitial Fibrosis

Overview

Pancreatic ductal adenocarcinoma (PDAC) accounts for 85-95% of pancreatic cancer and is one of the deadliest tumors in the world, with a survival rate of less than 8%, and identifying key prognostic or predictive factors facilitates risk stratification and prospective assessment in clinical trials. The extracellular matrix (ECM) surrounding PDAC often exhibits a large number of interstitial fibrosis, which is closely related to the formation, development and metastasis of PDAC. High order three-dimensional MR elastography (3D-MRE) allows non-invasive measurements of sheer stiffness in normal pancreas and pancreatic lesions. However, there are no reports about the application of MRE imaging biomarkers to predict the prognosis of PDAC at home and abroad.

Detailed description

Pancreatic ductal adenocarcinoma (PDAC) accounts for 85-95% of pancreatic cancer and is one of the deadliest tumors in the world, with a survival rate of less than 8%, and identifying key prognostic or predictive factors facilitates risk stratification and prospective assessment in clinical trials.

The extracellular matrix (ECM) surrounding PDAC often exhibits a large number of interstitial fibrosis, which is closely related to the formation, development and metastasis of PDAC. Although interstitial composition is considered a double-edged sword, influencing cancer biological progression and modification in multiple complex ways, experimental studies consistently demonstrate that hardening of ECM in PDAC accelerates PDAC progression and is significantly associated with shorter survival. If investigators can noninvasively detect the mechanical properties (hardness) of human PDAC before treatment, it will be helpful to describe the biological characteristics of tumors, predict the prognosis of patients, and choose the right clinical treatment decision.

High order three-dimensional MR elastography (3D-MRE) allows non-invasive measurements of sheer stiffness in normal pancreas and pancreatic lesions. However, there are no reports about the application of MRE imaging biomarkers to predict the prognosis of PDAC at home and abroad.

Interventions

  • Diagnostic test magnetic resonance imaging
    all participants undergo novel MR sequences, including 3D-MRE,DCE-MRI,IVIM-DWI,T1/T2 mapping.

Primary outcome measures

  • Analyzing the measurement accuracy of MRE. [Time frame: 9 months]
  • Radiological assessment of tumor stiffness. [Time frame: 9 months]
  • Evaluation of tumor response to chemotherapy. [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Shengjing hospital of china medical university — Shenyang

Publications

  • Yang A, Gu C, Liu Y, Luo B, Zeng Y, Zhou M, Li C, Pan C, Wu L, Hu Z, Zhang X, Gao F, Shi Y. ITGB5-mediated biomechanical regulation in pancreatic ductal adenocarcinoma stroma impacts tumor progression and prognosis. J Transl Med. 2025 Oct 21;23(1):1150. doi: 10.1186/s12967-025-07119-5. PMID 41121153

Identifiers

NCT: NCT06526442 · SJ-16001-MRE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗