Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: C189- Malignant neoplasm of colon, unspecified Health Condition 3: C19- Malignant neoplasm of rectosigmoidjunction Health Condition 4: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Ex vivo ICG fluorescence imaging with computer vision and machine learning: Fresh inked surgical specimen is imaged in a light tight box under 785 nm excitation
Sponsors
Mandya Institute of Medical Science MIMS
Indian Council for Medical Research ICMR
Manmed Dynamics LLP
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Day 0 within 0 to 4 hours after surgical excision imaging performed before histopathology sampling | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the ROC curve (AUC) for face-level classification of margin status.Timepoint: Day 0 1;umour-to-Background Ratio (TBR) threshold optimizing the Youden index.Timepoint: Day 0 1;Time-to-result (minutes) from specimen arrival in the lab to margin heatmap.Timepoint: Day 0;Per-slice sensitivity, specificity, PPV/NPV versus histopathology.Timepoint: Day 0 1;Concordance between AI hotspot location and histologic margin distance ( m).Timepoint: Day 0-1 | — |
Countries
India
Contacts
Public ContactIng Vishwas Gowda P N
Mandya Institute of Medical Science
Outcome results
None listed