Renal MassesNCT06517368
Ultrasound Elastography Combined With Conventional Mri in Differentiating Solid Renal Parenchyma Masses
An observational study of Renal Masses, run by Assiut University at 1 site in Egypt.
Trial summary
Investigate the diagnostic accuracy of Ultrasound Elastography combined with conventional MRI in evaluation of solid renal masses using histopathology as a gold standard. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Renal Masses
- What is being tested?
- MRI, Ultrasound
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2024to Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- patient with solid renal masses.
Who cannot join
- patient with cystic renal masses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Masses
- Being tested
- MRI, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI, UltrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| benign solid renal masses | Not described Receives: Device: MRI, Ultrasound | |
| malignant solid renal masses | Not described Receives: Device: MRI, Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start10 Aug 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal MassesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Mohamed Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517368
- Sponsor's protocol ID
- renal masses
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Elastography Combined With Conventional MRI in Differentiating Solid Renal Parenchyma Masses
- ClinicalTrials.gov ID
- NCT06517368
- Acronym / sponsor ID
- renal masses
- Conditions
- Renal Masses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate the diagnostic accuracy of Ultrasound Elastography combined with conventional MRI in evaluation of solid renal masses using histopathology as a gold standard.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| benign solid renal masses | – | Device: MRI, Ultrasound |
| malignant solid renal masses | – | Device: MRI, Ultrasound |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patient with solid renal masses.
Key exclusion criteria (1 listed)
- patient with cystic renal masses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI, UltrasoundThe 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. | Device | benign solid renal masses, malignant solid renal masses |
Primary outcome
Ultrasound Elastography combined with conventional mri in differentiating solid renal parenchyma masses
Time frame: Baseline
Investigate the diagnostic accuracy of Ultrasound Elastography combined with conventional MRI in evaluation of solid renal masses using histopathology as a gold stsndard.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Masses, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hager Mohamed Sayed, Master (01119330514, hagermohamed7127@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound Elastography combined with conventional mri in differentiating solid renal parenchyma masses (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.