NCT06517368

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

August 10, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

July 18, 2024

Last Update Submit

July 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

benign solid renal masses

Device: MRI, Ultrasound

malignant solid renal masses

Device: MRI, Ultrasound

Interventions

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.

benign solid renal massesmalignant solid renal masses

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • patient with solid renal masses.

You may not qualify if:

  • patient with cystic renal masses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit university

Asyut, Egypt

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Hager Mohamed Sayed, Master

CONTACT

Ahmed Mostafa Hamed

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

July 18, 2024

First Posted

July 24, 2024

Study Start

August 10, 2024

Primary Completion

December 30, 2025

Study Completion

January 1, 2026

Last Updated

July 24, 2024

Record last verified: 2024-07

Locations