Elastographic Analysis of Urothelial Bladder Tumours (SONURO)

June 3, 2024 updated by: University Hospital, Tours

Elastographic Analysis of Urothelial Bladder Tumours. Correlation of Elastography With Urodynamic Study and Tumour Grade

The preoperative evaluation of bladder tumors includes either computed tomography, magnetic resonance imaging in B-mode, or a cystoscopy in the absence of a radiological diagnosis. The diagnosis is confirmed after a transurethral resection of the bladder (TURB) and a histopathological analysis.

Ultrasound is a non-invasive imaging technique that uses high-frequency sound waves to produce images of internal structures. Conventional ultrasound in B-mode can only provide details about the tumor's number, size, and location.

Elastography uses ultrasound imaging techniques to examine the stiffness of a tissue. Using the Aixplorer system many recently published papers suggested that ShearWave Elasticity (SWE) imaging, enables the differentiation of low- from high-grade breast tumors by assessing the elasticity of the tissue.

Investigators intend to evaluate the stiffness of bladder tumors with ultrasound elastography in comparison with cystometry parameters and tumoral grade.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

According to European and French guidelines, Transurethral resection of the bladder can be followed by an administration of early postoperative intravesical chemotherapy. This treatment is indicated in the absence of presumed high grade tumor (preoperative high grade cytology) and in the absence of post-operative haematuria and bladder perforation. Unfortunately, urine cytology has a sensitivity for the detection of high-grade tumour of only 50%. Therefore, it is essential to predict more precisely the bladder tumor grade.

Ultrasound is a non-invasive imaging technique that uses high-frequency sound waves to produce images of internal structures. Conventional ultrasound in B-mode can only provide details about the tumor's number, size, and location.

Elastography uses ultrasound imaging techniques to examine the stiffness of a tissue. Using the Aixplorer system many recently published papers suggested that ShearWave Elasticity (SWE) imaging, enables the differentiation of low- from high-grade breast tumors by assessing the elasticity of the tissue. Many studies have shown a significant correlation between ultrasound elastography of the bladder wall with measurements of the detrusor pressure. Only one study, conducted by Huang et al., have assessed its application in the evaluation of bladder cancer with an intraluminal transducer. A significant difference between elasticity of low grade and high grade bladder tumors was found. However, no data on the impact of the intravesical volume over the tumoral elasticity is available.

The objective of this project is to evaluate the correlation between the ultrasound Elastography of urothelial bladder tumors with their tumoral grade before transurethral resection of the bladder.

Knowing that ultrasound Elastography is impacted by the pressure applied to a tissue, investigators intend to measure the tumoral elasticity - with an abdominal ultrasound transducer - during bladder filling with a monitoring of the intravesical pressure.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with a bladder tumour which needs a primary trans-urethral resection

Description

Inclusion Criteria:

  • Age > 18 years
  • Bladder tumour visualised on abdominal ultrasound or estimated to be more than 2 cm in diameter by fibroscopy or CT scan
  • Primary resection

Exclusion Criteria:

  • BMI > 30 kg/m2,
  • Bladder catheterisation,
  • Previous bladder or prostate surgery,
  • Previous intravesical instillation (BCG / Ametycine)
  • Previous pelvic radiotherapy,
  • Person having objected to data processing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental : Urothelial bladder tumour
Patient with an indication of transurethral resection of the bladder. Following the Urology consultation, the patient will be called for a trans-urethral bladder resection within 1 month. The patient will be admitted to the Urology Department of the Tours University Hospital the previous day.
Procedure: urethral bladder resection
urethral bladder resection. Per-operative bladder ultrasound elastography and simultaneous cystometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound elastography measurements
Time Frame: 10 minutes, during surgery
Measure of tumoral ultrasound elasticity (in kPa) with an abdominal ultrasound transducer.
10 minutes, during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between ultrasound results and histology
Time Frame: through study completion, an average of 10 months
Histology criteria : tumoral grade according to WHO classification (1973 and 2022)
through study completion, an average of 10 months
Comparison between ultrasound results and cystometry
Time Frame: through study completion, an average of 10 months
Cystometry data using an urodynamic system during the cystoscopy and simultaneous ultrasound measurements at successive filling volumes : intravesical pressure (cmH2O).
through study completion, an average of 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Franck BRUYERE, University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 26, 2024

Study Record Updates

Last Update Posted (Actual)

June 5, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR230158 - SONURO

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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