| CTRI Number |
CTRI/2025/10/095685 [Registered on: 07/10/2025] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role Of MRI In Diagnosing Rectal Cancer. |
|
Scientific Title of Study
|
Role Of MRI In Evaluation Of Rectal Carcinoma. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divyakshi Keni |
| Designation |
Post Graduate Student |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF RADIODIAGNOSIS, GROUND FLOOR, AVBRH BUILDING, SAWANGI, MEGHE
Wardha
MAHARASHTRA
442107
India |
| Phone |
7045864838 |
| Fax |
|
| Email |
divyakshik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivali Kashikar |
| Designation |
Professor |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF RADIODIAGNOSIS, GROUND FLOOR, AVBRH BUILDING, SAWANGI, MEGHE
Wardha
MAHARASHTRA
442107
India |
| Phone |
9822471380 |
| Fax |
|
| Email |
shivalikashikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivali Kashikar |
| Designation |
Professor |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF RADIODIAGNOSIS, GROUND FLOOR, AVBRH BUILDING, SAWANGI, MEGHE
Wardha
MAHARASHTRA
442107
India |
| Phone |
9822471380 |
| Fax |
|
| Email |
shivalikashikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Wardha |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College, Wardha |
| Address |
JNMC Campus, Sawangi(Meghe), Wardha, 442107 |
| Type of Sponsor |
Other [Deemed University] |
|
|
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 |
| Divyakshi Keni |
Acharya Vinoba Bhave Rural Hospital |
Department of Radiology,JNMC campus, sawangi(Meghe)
Wardha
MAHARASHTRA |
7045864838
divyakshik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE DMIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C20||Malignant neoplasm of rectum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of all age group irrespective of sex will be included.
2. Patients referred with clinical suspicion of rectal carcinoma as part of their clinical evaluation.
3. Patients who have given informed consent for MRI evaluation and inclusion in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patient with profuse per rectal bleeding including hemorrhoids.
2. Patients with contraindications to MRI (e.g., pacemakers, cochlear implants, or metallic foreign bodies, claustrophobia)
3. Patients who do not give consent/refusing investigations.
4. Pregnant patients unwilling to undergo MRI.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate characteristics of rectal lesion on MRI.
2.To compare the effectiveness of T2-weighted and diffusion-weighted MRI in staging the primary tumour and regional lymph nodes.
3.To assess the accuracy of MRI in predicting mesorectal fascia involvement and resection margin status in rectal cancer.
4.To correlate MRI findings with the histopathological diagnosis of rectal lesions.
|
Outcomes will be assessed at baseline(pre treatment), 4 weeks, 8 weeks, and at final follow up |
|
|
Secondary Outcome
|
|
|
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)
|
17/10/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Carcinoma rectum is a major health concern with increasing incidence globally. Accurate staging is critical for guiding treatment decisions, particularly in distinguishing candidates for neoadjuvant therapy versus direct surgical intervention. This thesis aims to evaluate the diagnostic performance and clinical impact of MRI in staging and restaging rectal carcinoma in patients from Central India. By correlating imaging findings with histopathology and clinical outcomes, this study seeks to highlight the role of MRI as a crucial, non-invasive tool in the multidisciplinary management of rectal cancer in this region. Furthermore,
MRI is instrumental in post-treatment evaluation to assess tumor response and
detect residual disease or complications.
|