Bladder Cancer
Conditions
Keywords
Non muscle invasive bladder cancer, multiparametric magnetic resonance imaging, second resection
Brief summary
The aim of the study is to prospectively assess the role of mpMRI as a non invasive method for assessment of possible residual tumor after initial resection of non muscle invasive bladder tumor.
Detailed description
Comprehensive multiparametric (mp) MRI which includes T2 weighted imaging, dynamic contrast enhanced (DCE) imaging and DWI, was proven to be efficient tool in differentiating benign and malignant bladder lesion. morphological characterization of malignant bladder lesion (mapping/size/morphology/stalk), T stage differentiation and histological grade discrimination. The application of mpMRI in NMIBC with its added value as non invasive tool for initial staging and after primary resection could be a new helpful method for better diagnosis, risk categorization, refining the indications of second resection and proper determination of adjuvant treatment.
Interventions
DEVICEmpMRI
all eligible patients will undergo mpMRI 4 weks after initial TURBT
PROCEDURESecond look TURBT
after mpMRI all patients will subjected to second look TURBT
Sponsors
Mansoura University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ability to give informed consent. 2. Patients with primary or recurrent papillary NMIBC. 3. Normal cardiac, hematological, and renal functions.
Exclusion criteria
* 1\. Patients with history of previous radiotherapy or systemic chemotherapy. 2. Patients suffering from immuno-deficiency or other malignancies. 3. Patients with high serum creatinine (more than 2 mg/dl). 4. Patients with contraindication to MRI (claustrophobia-pacemaker- metallic prosthesis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT | 1 year | assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT by comparing the results obtained by pre-second look TURBT mpMRI (Test of the study) with results of second look biopsy whether benign or malignant (Standard test). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2- Predictive capability of initial mpMRI of differentiation between NMIBC and muscle invasive disease. | 1 year | 2- Predictive capability of initial mpMRI of differentiation between NMIBC and muscle invasive disease. |
| Accuracy of bladder mapping in initial mpMRI (18) as a guide during TURBT. | 1 year | Accuracy of bladder mapping in initial mpMRI (18) as a guide during TURBT. |
| Predictive value of initial mpMRI for characterization of NMIBC (T stage, Grading, Risk categorization). | 1 year | Predictive value of initial mpMRI for characterization of NMIBC (T stage, Grading, Risk categorization). |
| Predictive capability of initial mpMRI of differentiation between benign and malignant bladder lesions. | 1 year | Predictive capability of initial mpMRI of differentiation between benign and malignant bladder lesions. |
| Morbidity (using modified Dindo-Clavian system for post-operative complications (19) and mortality rates after second look TURBT. | 1 year | Morbidity (using modified Dindo-Clavian system for post-operative complications (19) and mortality rates after second look TURBT. |
| Readmission rate after second look TURBT. | 1 year | Readmission rate after second look TURBT. |
| Cost comparison of mpMRI and second look TURBT. | 1 year | Cost comparison of mpMRI and second look TURBT. |
| Rate of over staging and under staging of NMIBC after second look TURBT in this prospective series. | 1 year | Rate of over staging and under staging of NMIBC after second look TURBT in this prospective series. |
Countries
Egypt
Contacts
Primary ContactAmr A Elsawy, MD
Backup ContactAhmed M Elshal
Outcome results
None listed