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MRE for Diagnosis of Pancreatic Masses

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06526442
Acronym
MREDPCM
Enrollment
200
Registered
2024-07-29
Start date
2020-10-09
Completion date
2027-06-01
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Magnetic Resonance Imaging, Pancreatic Neoplasm

Keywords

Pancreatic Cancer, solid pancreatic mass, Magnetic Resonance Elastography

Brief summary

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_TESTmagnetic resonance imaging

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

Sponsors

Yu Shi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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 criteria

1. inability to re-review of tissue specimens 2. unacceptable estimates of MRE parameters, specifically invalid wave data during postprocessing, inconsistent breath-holdings, intolerable pain, and MRE hardware disconnection 3. tumor diameters \<1.0 cm 4. withdrawal/dropout during follow-up

Design outcomes

Primary

MeasureTime frameDescription
Analyzing the measurement accuracy of MRE.9 monthsThe 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.
Radiological assessment of tumor stiffness.9 monthsA 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).
Evaluation of tumor response to chemotherapy.12 monthsRECIST criteria (version 1.1) were used to objectively evaluate the response to chemotherapy.

Countries

China

Contacts

CONTACTYu Shi, MD.PhD.
18940259980@163.com8618940259980
PRINCIPAL_INVESTIGATORYu Shi, MD.PhD.

Shengjing Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026