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Detection of tumour at the margins during surgery for breast cancer using Fluorescence and Diffuse Reflectance Imaging

Detection of margin positivity in breast cancer using Fluorescence and Diffuse Reflectance Imaging

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030410
Enrollment
66
Registered
2021-01-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C508- Malignant neoplasm of overlappingsites of breast

Interventions

Intervention1: Acquiring images of the excised specimens of the breast (both benign and malignant) with an indigenous device which utilizes fluorescence and diffuse reflectance. Images are acquired of

Sponsors

Dr Stanley Mathew
Lead Sponsor
Dr Subhash Narayanan
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adult female patients above 18 years 2.Pre operative diagnosis of carcinoma breast 3.Undergoing either Wide Local Excision + Axillary Dissection or Modified Radical Mastectomy 4.Patients who have undergone Neo Adjuvant Chemotherapy/ Neo Adjuvant Hormonal Therapy 5.Patients confirmed to have only benign lesions of the breast will be recruited for comparison and differentiating from malignant lesions

Exclusion criteria

Exclusion criteria: 1. Patients below 18 years 2. Patients not undergoing surgery for breast cancer

Design outcomes

Primary

MeasureTime frame
Determine the utility of Fluorescence and diffuse reflectance imaging in the diagnosis of Breast carcinomasTimepoint: 15 days (to obtain the report of HPE and validate the diagnosis)

Secondary

MeasureTime frame
1. Feasibility of identification of tumour free margins intraoperatively using Fluorescence and Diffuse reflectance. 2. Differentiating malignant from benign lesionsTimepoint: 15 days (to obtain the report of HPE and validate the diagnosis).

Countries

India

Contacts

Public ContactDr Vijayendra Kedage

Department of General Surgery, Kasturba Medical College, Manipal.

stanley.mathew@manipal.edu9844409900

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026