| CTRI Number |
CTRI/2025/11/097157 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study using Artificial Intelligence (AI) to differentiate between infection and cancer in PET/CT scans of the lung, head and neck, and breast |
|
Scientific Title of Study
|
Developing Predictive Models for Classifying Infection vs. Malignancy in PET/CT Imaging of Lung, Head and Neck, and Breast Cancer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandra Sony |
| Designation |
Research Scholar |
| Affiliation |
Manipal Institute of Technology |
| Address |
Research Lab 5, School of Computer Engineering, Innovation Centre (Academic Block 4),
Manipal Institute of Technology,
Manipal Academy of Higher Education (MAHE), Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9620608869 |
| Fax |
|
| Email |
sandra2.mitmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ananth Pai |
| Designation |
Head of Department and Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Medical Oncology,
Kasturba Medical College,
Manipal Academy of Higher Education (MAHE), Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9880239139 |
| Fax |
|
| Email |
ananth.pai@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hareesha K S |
| Designation |
Professor |
| Affiliation |
Manipal Institute of Technology |
| Address |
Director, International Centre for Applied Sciences (ICAS), Academic Block 5, LG-2, Manipal Institute of Technology,
Manipal Academy of Higher Education (MAHE), Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9481509128 |
| Fax |
|
| Email |
hareesh.ks@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,
Manipal, Udupi, Karnataka - 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal Institute of Technology |
| Address |
Manipal Institute of Technology , Manipal Academy of Higher Education (MAHE), Manipal, Udupi, Karnataka - 576104 |
| 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 Sumeet Suresh Malapure |
Kasturba Medical College |
Department of Nuclear Medicine, Shirdi Sai Baba Cancer Hospital and Research Centre, Kasturba Medical College, Manipal, Madhav Nagar, Udupi, Karnataka - 576104
Udupi
KARNATAKA |
9654007422
sumeet.malapure@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College and Kasturba Hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, (2) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, (3) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (4) ICD-10 Condition: C30-C39||Malignant neoplasms of respiratory and intrathoracic organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Histopathologically confirmed cases (via biopsy or FNAC) of carcinoma of the lung, breast, or head and neck.
2. Patients undergoing 18F-FDG PET/CT imaging for: Staging or restaging of malignancy;
Evaluation of Pyrexia of Unknown Origin (PUO) and/or suspected infectious pathology;
Assessment of imaging heterogeneity in known malignancies;
3. Availability of complete PET/CT imaging data in DICOM format
4. Availability of relevant clinical records
|
|
| ExclusionCriteria |
| Details |
1. Incomplete or poor-quality PET/CT imaging
2. Missing or inadequate clinical data
3. Pregnant women and lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improved diagnostic precision in differentiating infection from malignancy |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/12/2025 |
| 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="3"
Months="0"
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
|
This study aims to develop a hybrid predictive model to differentiate infection from malignancy using clinical data, radiomic features, and PET CT metabolic parameters. A comprehensive dataset will be collected, preprocessed, and analyzed. Machine learning methods will be used to identify key features and build a diagnostic model. The performance of the model will be validated and its ability to improve diagnostic accuracy and clinical decision making will be assessed across lung, breast, and head and neck cancer cases. |