Elastographic MeasurementSONURONCT06225726
Elastographic Analysis of Urothelial Bladder Tumours
An observational study of Elastographic Measurement and Intravesical Pressure Measurement, run by University Hospital, Tours at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elastographic Measurement, Intravesical Pressure Measurement
- What is being tested?
- urethral bladder resection
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2024to Feb 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a bladder tumour which needs a primary trans-urethral resection
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iyad CHAOUI contact
France1 site, 1 recruiting
- Recruiting
University hospital
Tours, 37044
Iyad CHAOUI, chaouiyad@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- urethral bladder resection
- Keywords
- urothelial bladder tumours, tumour grade, ShearWave Elasticity, Urodynamic study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urethral bladder resectionProcedure or surgery
urethral bladder resection. Per-operative bladder ultrasound elastography and simultaneous cystometry
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: urethral bladder resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound elastography measurements
Measure of tumoral ultrasound elasticity (in kPa) with an abdominal ultrasound transducer.
Measured: 10 minutes, during surgery
Secondary outcomes (2)
Comparison between ultrasound results and histology
Histology criteria : tumoral grade according to WHO classification (1973 and 2022)
Measured: through study completion, an average of 10 months
Comparison between ultrasound results and cystometry
Cystometry data using an urodynamic system during the cystoscopy and simultaneous ultrasound measurements at successive filling volumes : intravesical pressure (cmH2O).
Measured: through study completion, an average of 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start6 Feb 2024
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elastographic MeasurementStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck BRUYERE, Principal investigator, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225726
- Sponsor's protocol ID
- DR230158 - SONURO
- Acronym
- SONURO
- Status last verified
- Jun 2024
- First submitted
- 16 Jan 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elastographic Analysis of Urothelial Bladder Tumours. Correlation of Elastography With Urodynamic Study and Tumour Grade
- ClinicalTrials.gov ID
- NCT06225726
- Acronym / sponsor ID
- SONURO / DR230158 - SONURO
- Keywords
- urothelial bladder tumours, tumour grade, ShearWave Elasticity, Urodynamic study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 26 Jan 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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental : Urothelial bladder tumour | – | Procedure: urethral bladder resectionPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a bladder tumour which needs a primary trans-urethral resection
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- BMI > 30 kg/m2,
- Bladder catheterisation,
- Previous bladder or prostate surgery,
- Previous intravesical instillation (BCG / Ametycine)
- Previous pelvic radiotherapy,
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 |
|---|---|---|
| urethral bladder resectionurethral bladder resection. Per-operative bladder ultrasound elastography and simultaneous cystometry | Procedure or surgery | Experimental : Urothelial bladder tumour |
Primary outcome
Ultrasound elastography measurements
Time frame: 10 minutes, during surgery
Measure of tumoral ultrasound elasticity (in kPa) with an abdominal ultrasound transducer.
2 secondary outcomes
Comparison between ultrasound results and histology
Time frame: through study completion, an average of 10 months
Comparison between ultrasound results and cystometry
Time frame: through study completion, an average of 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: Undecided
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.
Iyad CHAOUI contact
Franck BRUYERE principal investigator
University Hospital
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 Elastographic Measurement and Intravesical Pressure Measurement, run by University Hospital, Tours at 1 site in France.
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 3 inclusion and 6 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 5 Jun 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 France. 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 Franck BRUYERE (247474372 ext. +33, f.bruyere@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound elastography measurements (time frame: 10 minutes, during surgery). 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 5 Jun 2024.