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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05787938
Collaborator
(none)
58
20

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: MRI

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
58 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
The Role of Magnetic Resonance Imaging in Assessment of the Urinary Bladder Wall Post Transurethral Tumor Resection
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Outcome Measures

Primary Outcome Measures

  1. The Role of Magnetic Resonance Imaging (MRI) in assessment of the urinary bladder wall transurethral tumor resection. [Baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Principal Investigator: Amr Farouk Muorad, Prof.Doctor, Assiut University
  • Principal Investigator: Mohamed Moamen Elbaroudy, doctor, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ayat Ibrahim Aboelela, Doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT05787938
Other Study ID Numbers:
  • MRI in urinary bladder tumors
First Posted:
Mar 28, 2023
Last Update Posted:
Mar 28, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 28, 2023