Role of MRI in Assessment of the Urinary Bladder Wall Post Transurethral Tumor Resection

Urinary Bladder Cancer Clinical Trial

Official title:

The Role of Magnetic Resonance Imaging in Assessment of the Urinary Bladder Wall Post Transurethral Tumor Resection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05787938
• Other study ID #: MRI in urinary bladder tumors
• Status: Not yet recruiting
• Start date: April 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2023
• Source: Assiut University
• Contact: Ayat Ibrahim, Resident Doctor
• Phone: 01068306016
• Email: ayatibrahim59[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To study the feasibility of using magnetic resonance imaging (MRI) in evaluation UB wall thickening after transurethral resection (TUR) of bladder cancer.

Description:

Urinary bladder carcinoma is the second most common tumour of the urinary tract and 70% of such carcinomas are non-muscle-invasive (superficial) at presentation. Transurethral resection (TUR) is the standard treatment; however, recurrence of the tumour is not uncommon so such patients require long-term close supervision.

Staging is based on TNM system. Ta tumors are treated with transurethral resection of bladder tumor (TUR-BT). T1 and carcinoma in situ (Tis) tumors have risk of progression and intravesical immunotherapy with Bacillus-Calmette-Guerin (BCG) instillations is used to obtain local control and organ preservation. Invasive bladder cancer (MIBC) is an aggressive disease and standard treatment is radical cystectomy (RC), accompanied by pelvic lymph node dissection (PLND). In addition to radical surgery, neoadjuvant chemotherapy (NAC) has been demonstrated to increase overall survival in MIBC and is recommended by consensus guidelines.

Compared to contrast enhanced CT, MRI has better soft tissue contrast which may improve local tumor evaluation.

Surveillance strategies for urinary bladder carcinoma recurrence have historically relied on cystoscopy, but this procedure has drawbacks, including its high cost, invasiveness and the fact that it may lead to iatrogenic bladder injury and urinary sepsis. In addition, it cannot diagnose upper tract tumours. The presence of a radiological method that could differentiate between benign and malignant lesions of the bladder would avoid the need for invasive cystoscopy, provided that upper tract tumours were excluded. Diffusion-weighted (DW) MRI is a non-invasive technique measuring the microscopic mobility of water molecules in the tissues without contrast administration. It provides information on perfusion and diffusion simultaneously in any organ, so it can be used to differentiate normal and abnormal structures of tissues, and it might help in the characterization of various abnormalities.

During follow-up of patients after trans-urethral resection (TUR), it is difficult to distinguish residual cancer from fibrotic and inflammatory changes secondary to TUR and intravesical chemotherapy, both of which manifest as bladder wall thickening on T2-weighted MRI.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: December 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

Inclusion Criteria:

-Patients who had a history of TUR of superficial bladder tumors and fit for the MRI examination.

Exclusion Criteria:

• Patients with pacemaker, claustrophobia or metallic prosthesis which are not MRI compatible.

• Patients with contraindications for cystoscopy (unfit for anesthesia or urethral stricture).

• Patients refusing consent for the study.

Related Conditions & MeSH terms

• Urinary Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Device:
• MRI
A procedure that uses radio waves, a powerful magnet, and a computer to make a series of detailed pictures of areas inside the body. A contrast agent, such as gadolinium, may be injected into a vein to help the tissues and organs show up more clearly in the picture. MRI may be used to help diagnose disease, plan treatment, or find out how well treatment is working. It is especially useful for imaging the brain and spinal cord, the heart and blood vessels, the bones, joints, and other soft tissues, the organs in the pelvis and abdomen, and the breast. Also called magnetic resonance imaging, NMRI, and nuclear magnetic resonance imaging.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

Dobson MJ, Carrington BM, Collins CD, Ryder WD, Read G, Hutchinson CE, Hawnaur JM. The assessment of irradiated bladder carcinoma using dynamic contrast-enhanced MR imaging. Clin Radiol. 2001 Feb;56(2):94-8. doi: 10.1053/crad.2000.0560. — View Citation

El-Assmy A, Abou-El-Ghar ME, Refaie HF, Mosbah A, El-Diasty T. Diffusion-weighted magnetic resonance imaging in follow-up of superficial urinary bladder carcinoma after transurethral resection: initial experience. BJU Int. 2012 Dec;110(11 Pt B):E622-7. doi: 10.1111/j.1464-410X.2012.11345.x. Epub 2012 Jul 3. — View Citation

Le Bihan D, Breton E, Lallemand D, Aubin ML, Vignaud J, Laval-Jeantet M. Separation of diffusion and perfusion in intravoxel incoherent motion MR imaging. Radiology. 1988 Aug;168(2):497-505. doi: 10.1148/radiology.168.2.3393671. — View Citation

Wang Y, Zhang W, Xiao W, Chen S, Wei Y, Luo M. Feasibility of Early Evaluation for the Recurrence of Bladder Cancer after Trans-Urethral Resection: A Comparison between Magnetic Resonance Imaging and Multidetector Computed Tomography. Tomography. 2022 Dec 22;9(1):25-35. doi: 10.3390/tomography9010003. — View Citation

Webb JA. Imaging in haematuria. Clin Radiol. 1997 Mar;52(3):167-71. doi: 10.1016/s0009-9260(97)80269-3. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Role of Magnetic Resonance Imaging (MRI) in assessment of the urinary bladder wall transurethral tumor resection.	To study the feasibility of using magnetic resonance imaging (MRI) in evaluation UB wall thickening after transurethral resection (TUR) of bladder cancer.	Baseline