Clinical trial NCT06225726: Elastographic Analysis of Urothelial Bladder Tumours
Official title: Elastographic Analysis of Urothelial Bladder Tumours. Correlation of Elastography With Urodynamic Study and Tumour Grade
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Elastographic Measurement
Intravesical Pressure Measurement
Keywords: urothelial bladder tumours
tumour grade
ShearWave Elasticity
Urodynamic study
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a bladder tumour which needs a primary trans-urethral resection

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ultrasound elastography measurements
timeFrame: 10 minutes, during surgery
Secondary outcomes:
measure: Comparison between ultrasound results and histology
timeFrame: through study completion, an average of 10 months
measure: Comparison between ultrasound results and cystometry
timeFrame: through study completion, an average of 10 months
Other outcomes:
Locations:
city: Tours
country: France
facility: University hospital
Study officials:
affiliation: University Hospital
name: Franck BRUYERE
role: PRINCIPAL_INVESTIGATOR
References: