| CTRI Number |
CTRI/2024/08/072179 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| 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 brain tumours using a non-contrast perfusion and diffusion MRI technique |
|
Scientific Title of Study
|
Optimization and Application of Hybrid Intravoxel Incoherent Motion – Diffusion Kurtosis Imaging in the Evaluation of Brain Tumours |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhijith S |
| Designation |
PhD Research Scholar |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
Department of Medical Imaging Technology, MCHP, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9481202810 |
| Fax |
|
| Email |
abhijith.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saikiran P |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
Department of Medical Imaging Technology, MCHP, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8320126806 |
| Fax |
|
| Email |
saikiran.p@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saikiran P |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
Department of Medical Imaging Technology, MCHP, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8320126806 |
| Fax |
|
| Email |
saikiran.p@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medica College and Kasturba Hospital, Manipal Academy of Higher Education, Manipal, Karnataka, 576104, India |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, 576104, India |
| Type of Sponsor |
Research institution |
|
|
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 Rajagopal K V |
Department of Radio-Diagnosis and Imaging, Kasturba Hospital |
Kasturba Medical College and Kasturba Hospital, MAHE, Manipal
Udupi
KARNATAKA |
9448158901
rajagopal.kv@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital, Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, (2) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Phase I: Patients referred for contrast-enhanced MRI brain scan
Phase II: Patients with brain tumours who have not undergone surgery or treatment for tumours
Patient with brain tumours post-surgery or post-chemo/radiotherapy |
|
| ExclusionCriteria |
| Details |
Phase I & II: Pregnant patient
Uncooperative patients
Patients contraindicated for MRI |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
IVIM:
D: True diffusion coefficient
D star: Pseudo diffusion coefficient
f: Perfusion fraction
DDC: Distributed diffusion coefficient
Alpha: Heterogeneity Index
MK: Mean Kurtosis
MD: Mean Diffusivity
DSC:
CBV: Cerebral Blood Volume
CBF: Cerebral Blood Flow
MTT: Mean Transit Time
TTP: Time to Peak
DWI:
ADC: Apparent Diffusion Coefficient |
At the time of scan |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DDC, alpha and D compared against ADC value in classification of tumours |
At the time of scan |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
07/09/2024 |
| 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="2"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study aimed to optimize a non-invasive, non-contrast IVIM-DKI sequence and evaluate its effectiveness in the evaluation of brain tumours. The study will be performed in 2 Phases. In Phase I, optimization of the protocol will be performed on patients (who may or may not have brain tumours) who were referred for an MRI contrast study with a sample size of 27. In Phase II , an optimized protocol will be used to evaluate brain tumours. This phase has 2 objectives; one is to evaluate the freshly diagnosed brain tumours prior to treatment with sample size of 33. Another one is to distinguish the recurrent/residual lesion from the post-treatment changes with the sample size time-bound. |