| CTRI Number |
CTRI/2021/05/033852 [Registered on: 28/05/2021] Trial Registered Prospectively |
| Last Modified On: |
25/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Reliability of MRI for VI-RADS scoring for detection of muscle invasion in urinary bladder carcinoma |
|
Scientific Title of Study
|
Multiparametric MRI for bladder cancer using VI-RADS for the detection of detrusor muscle invation: An observational study to check reliability of VI-RADS scoring in Indian population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ARJUN ANIL |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College and Kasturba Hospital |
| Address |
Department of Radiodiagnosis, Kasturba Medical College and Kasturba Hospital
Udupi
KARNATAKA
576104
India |
| Phone |
9873983939 |
| Fax |
|
| Email |
arjunanil3731@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakashini K |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College and Kasturba Hospital |
| Address |
Department of Radiodiagnosis, Kasturba Medical College and Kasturba Hospital
Udupi
KARNATAKA
576104
India |
| Phone |
9845053325 |
| Fax |
|
| Email |
prakashini.k@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DR ARJUN ANIL |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College and Kasturba Hospital |
| Address |
Department of Radiodiagnosis, Kasturba Medical College and Kasturba Hospital
Udupi
KARNATAKA
576104
India |
| Phone |
9873983939 |
| Fax |
|
| Email |
arjunanil3731@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital
Udupi, Hebri Road, Madhav Nagar, Manipal
Karnataka - 576104 |
|
|
Primary Sponsor
|
| Name |
Arjun Anil |
| Address |
Department of Radiodiagnosis, Kasturba Medical College and Kasturba Hospital |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arjun Anil |
Kasturba Hospital Manipal |
Department of radiodiagnosis, Kasturba Hospital
Udupi-Hebri road, Madhavnagar Manipal.
Udupi
KARNATAKA |
9873983939
arjunanil3731@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
(1) Patients who were initially diagnosed with bladder cancer received no treatment or received only diagnostic
transurethral resection.
(2) The final pathological results were confirmed to indicate a malignant bladder tumor. |
|
| ExclusionCriteria |
| Details |
(1) recurrence/residual tumors, or invasion by other tumors of adjacent organs
(2) patients who will have an unclear pathology finding (suboptimal or non-diagnostic multiparametric MRI)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Vesical Imaging-Reporting and Data System score effectively defines the likelihood of detrusor muscle invasion in bladder cancer and should be considered for evaluation of tumors prior to surgery |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
31/05/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective observational study, in which patients with carcinoma urinary bladder visiting Kasturba hospital, Manipal who have not undergone any prior treatment or received only diagnostic transurethral resection, will undergo an MRI-pelvis scan with dynamic contrast and will be scored on the basis of VI-RADS scoring system to assess involvement of detrusor muscle. The MRI findings will be then compared with the operative and histopathological findings, thus the reliability of VI-RADS scoring in Indian population can be assessed. |