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Evaluation of a non-invasive biopsy device for differentiating various lesions encountered during breast surgery

Evaluation of a non-invasive Optical Biopsy Device for differentiating various lesions during surgery of the breast

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035778
Enrollment
100
Registered
2021-08-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: D249- Benign neoplasm of unspecified breast Health Condition 2: C509- Malignant neoplasm of breast of unspecified site Health Condition 3: N630- Unspecified lump in unspecified breast

Interventions

Intervention1: Diffuse Reflectance Spectroscopy: Measurement of spectra in excised surgical specimens using spectrometer and light source Control Intervention1: Histopathology: Final histopathology of

Sponsors

Kasturba Medical College Manipal
Lead Sponsor
Dr Subhash Narayanan
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Adult female patients above 18 years Patients undergoing surgery for removal of lump in the breast

Exclusion criteria

Exclusion criteria: Patients with systemic conditions that contraindicate biopsy or surgery Severe inflammation or infection associated with the lesions

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of Diffuse Reflectance Spectrometry in detecting and differentiating benign and malignant tissue in the breast in comparison to final histopathology of the resected specimenTimepoint: 21 days—

Secondary

MeasureTime frame
Not applicableTimepoint: Not applicable—

Countries

India

Contacts

Public ContactDr Badareesh L

Kasturba Medical College Manipal

stanley.mathew@manipal.edu9844409900

Outcome results

None listed

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