Ultrasound Elastography Combined With Conventional Mri in Differentiating Solid Renal Parenchyma Masses

Ultrasound Elastography Combined With Conventional MRI in Differentiating Solid Renal Parenchyma Masses

Investigate the diagnostic accuracy of Ultrasound Elastography combined with conventional MRI in evaluation of solid renal masses using histopathology as a gold standard.

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Masses
• Intervention / Treatment: Device: MRI, Ultrasound

Detailed Description

Renal masses are increasingly detected incidentally during imaging that plays a key role in the characterization of these masses. Renal masses are a biologically heterogeneous group of tumors ranging from benign masses to cancers that can be indolent or aggressive.Typical imaging methods available for differentiating benign from malignant renal lesions include ultrasound (US), contrast-enhanced ultrasound (CEUS), computed tomography (CT), and magnetic resonance imaging (MRI). Renal mass biopsy is considered the gold standard for determining the presurgical histology of renal masses. US can easily characterize most incidental renal masses , but it cannot always differentiate between benign and malignant solid renal tumors.MR imaging has been gaining popularity in recent years as a problem-solving tool in the evaluation of renal masses.It has several advantages including no exposure to radiation and a superior soft-tissue contrast, and may be a feasible initial imaging option for characterization of renal tumors.Ultrasound elastography (USE) is an imaging technology sensitive to tissue stiffness that was first described in the 1990s.It takes advantage of the changed elasticity of soft tissues resulting from specific pathological or physiological processes. Ultrasound-based methods include strain elastography, two-dimensional shear wave elastography (2D-SWE), point shear wave elastography (pSWE), and vibration-controlled transient elastography (VCTE). US elastography is a non-invasive technique that can assess tissue elasticity, has shown promising results in many clinical settings, and could be able to differentiate between benign and malignant renal lesions based on tissue stiffness.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Hager Mohamed Sayed, Master; Phone Number: 01119330514; Email: hagermohamed7127@gmail.com
• Study Contact Backup: Name: Ahmed Mostafa Hamed; Phone Number: 01000024182; Email: ahmed.hamed2@med.aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt
    • Assuit university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The patients will undergo both B-mode and sonoelastographic examinations in the supine and lateral decubitus position and will perform during breath-holding after deep inspiration. The elastogram was displayed over the B-mode image in a color scale: red (greatest strain, softest tissue component), green (average strain, intermediate tissue component), and blue (no strain, hardest tissue component) Patients will be examined by MRI with diffusion images and ADC values.

Description

Inclusion Criteria:

• patient with solid renal masses.

Exclusion Criteria:

• patient with cystic renal masses.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
benign solid renal masses	Device: MRI, Ultrasound; The patients will undergo both B-mode and sonoelastographic examinations in the supine and lateral decubitus position and will perform during breath-holding after deep inspiration. The elastogram was displayed over the B-mode image in a color scale: red (greatest strain, softest tissue component), green (average strain, intermediate tissue component), and blue (no strain, hardest tissue component) Patients will be examined by MRI with diffusion images and ADC values.
malignant solid renal masses	Device: MRI, Ultrasound; The patients will undergo both B-mode and sonoelastographic examinations in the supine and lateral decubitus position and will perform during breath-holding after deep inspiration. The elastogram was displayed over the B-mode image in a color scale: red (greatest strain, softest tissue component), green (average strain, intermediate tissue component), and blue (no strain, hardest tissue component) Patients will be examined by MRI with diffusion images and ADC values.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound Elastography combined with conventional mri in differentiating solid renal parenchyma masses	Investigate the diagnostic accuracy of Ultrasound Elastography combined with conventional MRI in evaluation of solid renal masses using histopathology as a gold stsndard.	Baseline

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): August 10, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: renal masses

Drug and device information, study documents

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