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Elastographic Analysis of Urothelial Bladder Tumours

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06225726
Acronym
SONURO
Enrollment
50
Registered
2024-01-26
Start date
2024-02-06
Completion date
2025-02-28
Last updated
2024-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elastographic Measurement, Intravesical Pressure Measurement

Keywords

urothelial bladder tumours, tumour grade, ShearWave Elasticity, Urodynamic study

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.

Interventions

PROCEDUREurethral bladder resection

urethral bladder resection. Per-operative bladder ultrasound elastography and simultaneous cystometry

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Ultrasound elastography measurements10 minutes, during surgeryMeasure of tumoral ultrasound elasticity (in kPa) with an abdominal ultrasound transducer.

Secondary

MeasureTime frameDescription
Comparison between ultrasound results and histologythrough study completion, an average of 10 monthsHistology criteria : tumoral grade according to WHO classification (1973 and 2022)
Comparison between ultrasound results and cystometrythrough study completion, an average of 10 monthsCystometry data using an urodynamic system during the cystoscopy and simultaneous ultrasound measurements at successive filling volumes : intravesical pressure (cmH2O).

Countries

France

Contacts

Primary ContactFranck BRUYERE
f.bruyere@chu-tours.fr247474372
Backup ContactIyad CHAOUI
chaouiyad@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026