Role of Diffusion -Weighted MRI in Evaluation of Urinary Bladder Masses

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05097105
Collaborator
(none)
50
1
24
2.1

Study Details

Study Description

Brief Summary

Urinary bladder cancer is a common malignant tumor of the urinary tract in both men and women. Proper management of the urinary bladder cancer depends on the stage of the lesions.

Differentiating the histopathological types, tumor grade and the depth of tumor invasion are very important for determining the therapeutic approach and are highly correlated with the recurrence, progression and patient's survival.

Radical cystectomy (RC) and lymphadenectomy after neoadjuvant chemotherapy is the standard treatment for muscle invasive tumors, whereas the treatment of choice for non-muscle invasive tumors is transurethral resection (TUR) ±chemo/immunotherapy.

Cystoscopy with biopsy is still the best tool for bladder cancer staging due to its high sensitivity in detecting lesions and the possibilities of tumor resections, but the main drawbacks are invasiveness, limitation in detection of flat lesions, and lack of the assessment of extra-vesical tumor invasion. Modern diagnostic modalities circumvent these limitations like blue-light cystoscopic examination and infrared cystoscopy.

For the radiological evaluation of the urinary bladder, magnetic resonance imaging (MRI) is a valuable imaging modality due to high tissue contrast and multiplanar imaging capabilities.

Diffusion-weighted images provides useful information for evaluation of local T stage of the urinary bladder cancer, specially in differentiating T1 stage or lower tumors from T2 stage and higher tumor stages.

Apparent diffusion coefficient (ADC) delineating the degree of water molecular diffusion and the degree of restriction to water diffusion in biological tissues is inversely correlated to the integrity of the cell membranes and the tissue cellularity.

The apparent diffusion coefficient (ADC) value has been revealed as quantitative measure of the degree of malignancy of the lesions. Decreased ADC values were reported with malignant lesions which have a larger cell diameter and more cellularity than normal tissue.

Condition or Disease Intervention/Treatment Phase
  • Device: MRI

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Role of Diffusion -Weighted MRI in Evaluation of Urinary Bladder Masses
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
urilogic patients

Device: MRI
MRI sequences: TI. T2 and diffusion weighted

Outcome Measures

Primary Outcome Measures

  1. Diagnosis of urinary bladder masses [2 years]

    detection and grading of urinary bladder masses using ADC value and pattern of signal of restriction in diffusion weighted image .

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All

Inclusion Criteria :• Age, any age will be included

  • Sex, both genders are included.

  • Patient presenting with heamaturia or intractable cystitis and urinary bladder mass lesions detected on ultrasound and/or CT examinations (with contrast).

Exclusion Criteria:

• General contraindications to MR imaging (pacemaker, metallic prostheses and clostrophobia).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Walaa Refaat Abdellah, Assistant lecture of Radiology, Sohag University
ClinicalTrials.gov Identifier:
NCT05097105
Other Study ID Numbers:
  • Soh-Med-21-10-32
First Posted:
Oct 27, 2021
Last Update Posted:
Oct 27, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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 Oct 27, 2021