Health TrialsbyHealthPanel

MRE for Diagnosis of Pancreatic Masses

ConditionsPancreatic NeoplasmMagnetic Resonance Imaging
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorYu Shi

About this trial

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.

Eligibility criteria

This trial accepts 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: Plan to include patients with resectable pancreatic cancer 1501 intervention
Group B: Plan to include patients with unresectable pancreatic cancer 501 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 (ӡ, 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

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
Apply now