| CTRI Number |
CTRI/2025/07/091016 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Diagnostic Accuracy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Mammography AI for Identifying Abnormalities |
|
Scientific Title of Study
|
Multi-centre Evaluation of Artificial Intelligence for Triage of Mammograms in Indian population |
| Trial Acronym |
MAIA (Mammographic Abnormality Identification with AI) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krithika Rangarajan |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
DR.BRAIRCH Building ,Radiology Department, 1st floor Room No-160-B, AIIMS Delhi
South West
DELHI
110029
India |
| Phone |
01129575064 |
| Fax |
|
| Email |
krithikarangarajan@aiims.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Krithika Rangarajan |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
DR.BRAIRCH Building,Radiology Department,1st floor,Room No-160-B, AIIMS Delhi
South West
DELHI
110029
India |
| Phone |
01129575064 |
| Fax |
|
| Email |
krithikarangarajan@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Krithika Rangarajan |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
DR.BRAIRCH Building,Radiology Department, 1st floor, Room No-160-B, AIIMS Delhi
South West
DELHI
110029
India |
| Phone |
01129575064 |
| Fax |
|
| Email |
krithikarangarajan@aiims.edu |
|
|
Source of Monetary or Material Support
|
| 122-C, Shastri Bhawan, Ministry of Education, government of India, New Delhi. |
|
|
Primary Sponsor
|
| Name |
Ministry Of Education |
| Address |
122-C, Shastri Bhawan, Ministry of Education, government of India, New Delhi. |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Krithika Rangarajan |
AIl India Institute of Medical Sciences Delhi |
IRCH,Radiology Department, 1st floor,Room No-160-B AIIMS New Delhi
South West
DELHI |
01129575064
krithikarangarajan@aiims.edu |
| Sanjay Thulkar |
National Cancer Institute Jhajjar AIIMS |
Radiology Department,Room No-048,Ground Floor.
Jhajjar
HARYANA |
9811411551
sanjaythulkar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Agartala Government Medical College Government of Tripura |
Approved |
| All India Instituite of Medical Sciences |
Approved |
| All India Institute of Medical Sciences Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy women in eligible age groups would be offered mammography for screening for breast cancer |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Patients who undergo routine mammography for screening or for evaluation of breast related complains |
|
| ExclusionCriteria |
| Details |
Mammograms performed for the purpose of interventions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Were any cancers missed by AI+ Technologist which were captured by radiologist in routine workflow |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of workload reduction that can be achieved by this protocol |
1 year |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
01/08/2025 |
| 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="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
|
In this study we explore the diagnostic accuracy of AI + technologist in ruling out presence of cancers in patients classified as having "No cancer" with very high confidence by AI alone in comparison with routine radiologist evaluation. We also study the potential workload reduction achieved by this method, to estimate whether this AI powered mammography can be offered at population level |