Mri and Ultrasound Elastography in Pancreatic Masses

Diffusion Weighted MRI Compared to Ultrasound Elstography in the Assessment of Pancreatic Masses.

To compare transcutaneous ultrasound elstography to Diffusion weighted MRI in differentiating between benign and malignant pancreatic masses.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Masses
• Intervention / Treatment: Device: MRI and Ultrasound Elastography

Detailed Description

There are many types of pancreatic masses classified based on their nature (benign vs. malignant), type (solid vs. cystic), and histological characteristics such as pancreatic cysts, pseudocysts with pooled prevalence rate of 8%,, pancreatic ductal carcinoma (PDAC) accounts for more than 85%, neuroendocrine tumors (NET) less than 5%, and solid pseudopapillary neoplasms account for approximately 0.9%-2.7% of all exocrine pancreatic neoplasms and 5% of cystic pancreatic neoplasms. Moreover, there are some pancreatic tumorous diseases such as chronic pancreatitis and autoimmune pancreatitis .

Pancreatic cancer has a low 5-year relative survival rate of 9% .Unfortunately, the global incidence of pancreatic ductal adenocarcinoma (PDAC) is increasing by about 1% annually Presently, PDAC is the seventh leading cause of cancer-related mortality in the world, with more than 300,000 deaths reported each year.

Typically, imaging assessment is the initial process in the diagnosis of PDAC. Endoscopic ultrasonography (EUS) and/or endoscopic retrograde pancreatography may be considered as reliable tools with higher diagnostic ability. However, because of the recent trend of reducing patient burden while ensuring safety, less-invasive methods may be preferred for practical management.

Currently, the commonly used imaging examinations for pancreatic lesions include computed tomography (CT) and magnetic resonance imaging (MRI). However, despite tremendous advances in imaging, it is still challenging to accurately characterize some pancreatic lesions based on morphological imaging, such as identifying small lesions and differentiating pancreatic adenocarcinoma and mass-forming pancreatitis which represents about 5-10% of pancreatic mass cases.

Diffusion weighted imaging (DWI) is an MRI method that provides information about the microstructural characteristics of tissues by detecting the random molecular motion of water molecules and generates representative ADC values.

Diffusion-weighted imaging (DWI) provides functional information on mass tissue, like cellular density, which cannot be obtained from morphological imaging.

Previous studies showed that DWI could improve staging and prognosis evaluation of pancreatic masses and help detect small pancreatic cancers as well as differentiate pancreatic cancer from mass-forming pancreatitis.

Ultrasound elastography is a relatively new diagnostic technique for measuring tissue elasticity (hardness) by palpation.

pancreatic masses can be diagnosed using elastography as the tissue elasticities of benign and malignant tissues differ.

normally the entire pancreas has an intermediate stiffness, and the shear wave speed is about 1.4 m/sec.

There are various types of elastography devices, and each utilizes different mechanisms. In the established guideline on ultrasound elastography, the various types of elastography are classified into strain elastography, shear wave elastography, transient elastography, and acoustic radiation force impulse (ARFI) imaging.

Out of the four types of elastographies that are used in the clinical setting, strain and shear wave elastographies are mainly used in pancreatic diseases.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yousra Ahmed Osman, Master degree; Phone Number: +201099370292; Email: yousra.ahmed.osman@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patients referred to radiology department presented clinically with pancreatic masses and willing to participate in the study.

Exclusion Criteria:

• preoperative chemotherapy/radiotherapy cases, pancreatic stenting cases, recurrent cases after previous resection.
• patients diagnosed as acute and chronic pancreatitis
• other contraindications to MRI such as cardiac pacemaker,claustrophobia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: pancreatic mass GROUP	Device: MRI and Ultrasound Elastography; transcutaneous ultrasound elastography and MRI abdomen with diffusion to evaluate pancreatic mass as regard of probability of mass to be malignancy ,size of the mass ,relation to pancreatic duct and bile duct evaluation with their result will be compared to the pathologic finding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
for shear wave elastography	increased shear wave speed suggesting malignancy	2 years
efficacy diffusion-weighted MRI to differentiate benigen and malignant pancreatic lesions	a decrease in ADC and hyperintensity signals on DWI suggesting malinant lesion	2 year
The quality evaluation for strain elastography : color pattern diagnosis is used for major color tones (blue: hard, red: soft) of tumors		2 years
Strain ratio: high strain ratio indicate that the tumor stiffer than surrounding suggesting malignancy		2 year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 8, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: MRIandUSE in pancreatic masses

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No