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NCT Number: NCT06526442

MRE for Diagnosis of Pancreatic Masses

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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 (ӡ, 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.

Study contacts

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

Yu Shi, MD.PhD.

CONTACT

[email protected]

8618940259980

Sponsors and collaborators

Lead sponsor

Yu Shi

Other

Registry information

Official study title

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

Acronym: MREDPCM

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Jul 29, 2024
Registry last updated
Feb 13, 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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