| CTRI Number |
CTRI/2025/11/097943 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A lab study using a dye glow camera and artificial intelligence to quickly check on the removed tissue sample whether cancer has been fully removed in breast and colorectal surgery. |
|
Scientific Title of Study
|
Smart Surgical Margins: An Artificial Intelligence Powered RealTime Cancer Residual Detection Using Fluorescence Imaging System: A Cross-Sectional Study at a Tertiary Care Hospital in Mandya |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1331-0551 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Lingaraju |
| Designation |
Associate professor and Neurosurgeon |
| Affiliation |
Mandya Institute of Medical Science |
| Address |
Unit C Department of General Surgery MIMS 3rd cross Guthal road Maruthi nagar Mandya Karnataka 571401 India
Mandya
KARNATAKA
571401
India |
| Phone |
9480387075 |
| Fax |
|
| Email |
1983lingu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Lingaraju |
| Designation |
Associate professor and Neurosurgeon |
| Affiliation |
Mandya Institute of Medical Science |
| Address |
Unit C Department of General Surgery MIMS,3rd cross Guthal road Maruthi nagar Mandya Karnataka 571401 India
KARNATAKA
571401
India |
| Phone |
9480387075 |
| Fax |
|
| Email |
1983lingu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ing Vishwas Gowda P N |
| Designation |
Lead research and development engineer |
| Affiliation |
Manmed Dynamics LLP |
| Address |
206 Panakanahalli Kasaba hobli Konanahalli post Mandya
Mandya
KARNATAKA
571403
India |
| Phone |
8197239974 |
| Fax |
|
| Email |
vishwas.gowda@manmed.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR) - Intramural
V Ramalingaswami Bhawan Ansari Nagar New Delhi 110029 India
Monetary support grant
Government funding agency |
| Mandya Institute of Medical Sciences (MIMS)
3rd cross Guthal road Maruthi nagar Mandya Karnataka 571401 India
In kind clinical and pathology support
Government medical college hospital |
| ManMed Dynamics LLP
206 Panakanahalli Kasaba hobli Konanahalli post Mandya 571403
In kind engineering imaging rig and AI compute
Industry private company |
|
|
Primary Sponsor
|
| Name |
Mandya Institute of Medical Science MIMS |
| Address |
3rd cross Guthal road Maruthi nagar Mandya Karnataka 571401 India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Indian Council for Medical Research ICMR |
V Ramalingaswami Bhawan Ansari Nagar New Delhi 110029 India |
| Manmed Dynamics LLP |
206 Panakanahalli Kasaba hobli Konanahalli post Mandya 571403 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr N Lingaraju |
Mandya Institute of Medical Science |
Department of Surgery 3rd cross Guthal road Maruthi nagar Mandya Karnataka 571401 India
Mandya
KARNATAKA |
9480387075
1983lingu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee, MIMS, Mandya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, (2) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (3) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, (4) ICD-10 Condition: C20||Malignant neoplasm of rectum, |
|
|
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 |
Adults aged 18 years and above
Primary breast cancer or colorectal cancer scheduled for surgery with curative intent R0 goal
Fresh excised specimen available immediately for ex vivo imaging in the laboratory
Indocyanine green used as per routine care or eligible for topical ex vivo protocol as approved by ethics
Specimen orientation recorded and margins inked before imaging
Time from excision to imaging within four hours
Written informed consent obtained or ethics approved waiver for discarded tissue |
|
| ExclusionCriteria |
| Details |
Metastatic disease or palliative cytoreductive resections
Known hypersensitivity to indocyanine green or iodides when systemic indocyanine green is used
Pregnancy or lactation when systemic indocyanine green is not permitted by local policy
Specimen unsuitable for imaging due to heavy cautery fragmentation inadequate fluorescence or gross contamination
Time to imaging more than four hours after excision
Uncontrolled diabetes as judged by the treating team if you wish to retain this from your proposal
Any serious medical or logistical condition that prevents safe handling imaging or timely processing of the specimen
Any exclusion mandated by the Institutional Ethics Committee |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Per-face sensitivity and specificity of the index test (ex-vivo ICG fluorescence and Machine Learning) to detect positive or close margins compared with histopathology (H and E) as reference standard. |
Day 0 within 0 to 4 hours after surgical excision imaging performed before histopathology sampling |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Area under the ROC curve (AUC) for face-level classification of margin status. |
Day 0–1 |
| umour-to-Background Ratio (TBR) threshold optimizing the Youden index. |
Day 0–1 |
| Time-to-result (minutes) from specimen arrival in the lab to margin heatmap. |
Day 0 |
| Per-slice sensitivity, specificity, PPV/NPV versus histopathology. |
Day 0–1 |
| Concordance between AI hotspot location and histologic margin distance (µm). |
Day 0-1 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/05/2026 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vishwas.gowda@manmed.in].
- For how long will this data be available start date provided 01-05-2026 and end date provided 01-05-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a prospective observational cross sectional diagnostic accuracy study that evaluates an ex vivo near infrared indocyanine green fluorescence imaging system with computer vision and machine learning for assessment of surgical margins on excised breast and colorectal cancer specimens. Fresh inked specimens are imaged in a light tight enclosure under 785 nm excitation with about 830 nm emission capture. The index test produces margin heatmaps and tumour to background ratio metrics on an NVIDIA Jetson platform. The reference standard is histopathology H and E of targeted and control slices from each margin face. Primary outcomes are sensitivity specificity and area under the ROC curve for face level classification against histopathology. Secondary outcomes include time to result per slice diagnostic metrics inter observer agreement and concordance of AI hotspots with histologic margin distance. Adults of eighteen years and above undergoing curative intent surgery are included. Metastatic disease and specimens unsuitable for imaging are excluded. The goal is to deliver same day triage that guides pathology slicing reduces delays and builds a labelled dataset for future in vivo translation. |