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CTRI Number  CTRI/2022/02/040206 [Registered on: 10/02/2022] Trial Registered Prospectively
Last Modified On: 09/02/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of ability of MRI scan in identifying muscle layer of urinary bladder in urinary bladder cancer patients 
Scientific Title of Study   Evaluation of Multi-parametric Magnetic Resonance Imaging in Identifying Muscle Invasion in Patients Undergoing Restage Transurethral Resection of bladder: A Cross-Sectional Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  G Rohith 
Designation  Senior Resident 
Affiliation  AIIMS, Bhubaneswar 
Address  Department of Urology, AIIMS, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone    
Fax    
Email  sr_rohith@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Swarnendu Mandal 
Designation  Assistant professor 
Affiliation  AIIMS, Bhubaneswar 
Address  Department of Urology, AIIMS, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone    
Fax    
Email  urol_swarnendu@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Swarnendu Mandal 
Designation  Assistant professor 
Affiliation  AIIMS, Bhubaneswar 
Address  Department of Urology, AIIMS, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone    
Fax    
Email  urol_swarnendu@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
AIIMS, Bhubaneswar 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  Department of Urology, AIIMS, Bhubaneswar 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr G Rohith  AIIMS, Bhubaneswar  Room number 243, Department of urology, OPD block, AIIMS, Bhubaneswar PIN: 751019
Khordha
ORISSA 		 9014817798

sr_rohith@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C679||Malignant neoplasm of bladder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Written informed consent.
Patients undergoing Restage Transurethral resection of bladder mass. 
 
ExclusionCriteria 
Details  ASA Grade 3 or more.
Patients with muscle invasive disease on initial TURBT
Patients with small (less than 3cm), non-invasive, unifocal, low grade polypoidal growths in
which restage TURBT is not indicated
Patients with impaired renal function;
Patients with claustrophobic disorder.
Patients with MR “unsafe” or “conditional” devices. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
the ability of multiparametric MRI in identifying muscle invasion in patients with bladder mass.  2 weeks after the surgery 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sr_rohith@aiimsbhubaneswar.edu.in].

  6. For how long will this data be available start date provided 01-12-2023 and end date provided 01-12-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Bladder cancer is the tenth most common and the thirteenth most deadly cancer worldwide. Transurethral resection of bladder cancer is the primary treatment modality for urinary bladder masses. After the initial resection, most of the tumors are Ta-T1 stage with no muscle invasion seen in the histopathological examination. Although Non-muscle invasive bladder cancer (NMIBC) cases account for more than 70-80% of the cases, the prognosis
significantly varied when compared to muscle-invasive bladder cancer (MIBC). Thus, it is imperative to not miss muscle-invasive disease post initial TURBT. Around 45% of the initial resections don’t include muscle and it was known that 7-30% of the MIBC cases are wrongly understated as NMIBC. So, a second look repeated TURBT (re-TURBT) 2-6 weeks following the initial TURBT is considered as standard management.

Multiparametric magnetic resonance imaging (mp-MRI) for bladder cancer is increasingly being employed in assessing the bladder walls so as to identify muscle involvement preoperatively. Various prospective and retrospective studies have validated the Vesical Imaging Reporting and Data System (VI-RADS) score in assessing the muscle invasion in patients with bladder masses in preoperative setting but, due to the limited number of trials
and various methodological drawbacks in them, no concrete conclusions were drawn on incorporating mp-MRI in the standard treatment protocols. So we intend to perform the current study to establish the efficacy of the VIRADS scoring system in predicting muscle invasion in patients with bladder cancer.
 
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