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

NCT05097105 | Unknown

• 1 other identifier: Soh-Med-21-10-32
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Bladder Neoplasm

Outcome Measures

Primary Outcomes (1)

• Diagnosis of urinary bladder masses

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

  2 years

Study Arms (1)

urilogic patients

Device: MRI

Interventions

MRI DEVICE

MRI sequences: TI. T2 and diffusion weighted

urilogic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

• Daneshmand S, Bazargani ST, Bivalacqua TJ, Holzbeierlein JM, Willard B, Taylor JM, Liao JC, Pohar K, Tierney J, Konety B; Blue Light Cystoscopy with Cysview Registry Group. Blue light cystoscopy for the diagnosis of bladder cancer: Results from the US prospective multicenter registry. Urol Oncol. 2018 Aug;36(8):361.e1-361.e6. doi: 10.1016/j.urolonc.2018.04.013. Epub 2018 May 30.

  PMID: 29859728 BACKGROUND

• Koh DM, Collins DJ. Diffusion-weighted MRI in the body: applications and challenges in oncology. AJR Am J Roentgenol. 2007 Jun;188(6):1622-35. doi: 10.2214/AJR.06.1403.

  PMID: 17515386 BACKGROUND

• Green DA, Rink M, Hansen J, Cha EK, Robinson B, Tian Z, Chun FK, Tagawa S, Karakiewicz PI, Fisch M, Scherr DS, Shariat SF. Accurate preoperative prediction of non-organ-confined bladder urothelial carcinoma at cystectomy. BJU Int. 2013 Mar;111(3):404-11. doi: 10.1111/j.1464-410X.2012.11370.x. Epub 2012 Jul 13.

  PMID: 22805163 BACKGROUND

• Amin MF, Abd El Hamid AM. The diagnostic accuracy of multidetector computed tomography with multiplanar reformatted imaging and virtual cystoscopy in the early detection and evaluation of bladder carcinoma: comparison with conventional cystoscopy. Abdom Imaging. 2013 Feb;38(1):184-92. doi: 10.1007/s00261-012-9902-6.

  PMID: 22623028 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Walaa R Abdellah, assistant lecture

CONTACT

01099870794; walaa.mahmoud@med.sohag.edu.eg

Mohammed TH Mahmoud, professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecture of Radiology

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: October 27, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)