| CTRI Number |
CTRI/2025/07/091679 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing a New CT Chest Scan Method with the Standard One to See Which Uses Less Radiation and Still Gives Clear Images |
|
Scientific Title of Study
|
Assessment of Comparative Efficacy of Modified CT Scanning Protocol Versus Standard Protocol- A Diagnostic Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suhas Pruthviraj Tivaskar |
| Designation |
Ph.D Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Deemed to be University |
| Address |
Dept of Radiodiagnosis, Ground Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9967519211 |
| Fax |
|
| Email |
suhas.tiwaskar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anurag Luharia |
| Designation |
Ph.D Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Deemed to be University |
| Address |
Dept of Radiodiagnosis, Ground Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9730180151 |
| Fax |
|
| Email |
anuragluharia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suhas Pruthviraj Tivaskar |
| Designation |
Ph.D Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Deemed to be University |
| Address |
Dept of Radiodiagnosis, Ground Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9967519211 |
| Fax |
|
| Email |
suhas.tiwaskar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha, India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Anurag Luharia |
Acharya Vinoba Bhave Rural Hospital |
Dept of Radiodiagnosis, Ground Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA |
9730180151
anuragluharia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research, Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, |
|
|
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 |
1.Patients aged 18 years or older scheduled for CT evaluation.
2.Able to provide informed consent.
3.Able to cooperate and are clinically stable.
|
|
| ExclusionCriteria |
| Details |
1.Patients below the age of 18 years.
2.Clinically unstable and patients due to severe medical or psychiatric conditions.
3.Contraindications to CT e.g., non-compatible implants, claustrophobia etc.
4.Pregnancy or breastfeeding.
5.Non cooperative patients.
6.Non consenting patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Radiation dose will be reduced and Image quality will be improved using modified CT scanning protocol compared to standard protocol. |
Assessment will be done at 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="30"
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)
|
15/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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
|
This Ph.D. research aims to evaluate and compare a modified CT scanning protocol with the standard protocol for chest imaging, focusing on reducing radiation dose without compromising diagnostic image quality. The study is conducted in two phases using both phantom and patient-based data, with assessments based on objective image quality metrics (SNR, CNR) and radiation dose (CTDI, DLP). By utilizing Catphan 604 phantoms and clinical validation, the research intends to establish a safer, optimized imaging protocol especially applicable in resource-limited rural healthcare settings, aligning with the ALARA principle for improved patient safety and diagnostic efficacy. |