Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-28 @ 7:51 PM
Study NCT ID:
NCT06517368
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-24
First Post:
2024-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Elastography Combined With Conventional Mri in Differentiating Solid Renal Parenchyma Masses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-18', 'studyFirstSubmitDate': '2024-07-18', 'studyFirstSubmitQcDate': '2024-07-18', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasound Elastography combined with conventional mri in differentiating solid renal parenchyma masses', 'timeFrame': 'Baseline', 'description': 'Investigate the diagnostic accuracy of Ultrasound Elastography combined with conventional MRI in evaluation of solid renal masses using histopathology as a gold stsndard.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Masses']}, 'descriptionModule': {'briefSummary': 'Investigate the diagnostic accuracy of Ultrasound Elastography combined with conventional MRI in evaluation of solid renal masses using histopathology as a gold standard.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with solid renal masses.\n\nExclusion Criteria:\n\n* patient with cystic renal masses.'}, 'identificationModule': {'nctId': 'NCT06517368', 'briefTitle': 'Ultrasound Elastography Combined With Conventional Mri in Differentiating Solid Renal Parenchyma Masses', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Ultrasound Elastography Combined With Conventional MRI in Differentiating Solid Renal Parenchyma Masses', 'orgStudyIdInfo': {'id': 'renal masses'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'benign solid renal masses', 'interventionNames': ['Device: MRI, Ultrasound']}, {'label': 'malignant solid renal masses', 'interventionNames': ['Device: MRI, Ultrasound']}], 'interventions': [{'name': 'MRI, Ultrasound', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['benign solid renal masses', 'malignant solid renal masses']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assuit university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Hager Mohamed Sayed, Master', 'role': 'CONTACT', 'email': 'hagermohamed7127@gmail.com', 'phone': '01119330514'}, {'name': 'Ahmed Mostafa Hamed', 'role': 'CONTACT', 'email': 'ahmed.hamed2@med.aun.edu.eg', 'phone': '01000024182'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Hager Mohamed Sayed', 'investigatorAffiliation': 'Assiut University'}}}}