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Lymph node identification in skin malignancy using indocyanine green transcutaneously study: Study protocol for a

Ioana Lese1,2, Jonathan Ian Leckenby1,3, Adriano Taddeo2

  • 1Department of Plastic and Hand Surgery, Inselspital.

Medicine
|November 7, 2019
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Summary

This study evaluates a new near-infrared fluorescence imaging device for identifying sentinel lymph nodes (SLNs) in skin cancer patients. The goal is to determine if this technology can replace radioactive tracers for more accurate SLN detection.

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Area of Science:

  • Oncology
  • Surgical Innovation
  • Medical Imaging

Background:

  • Rising incidence of malignant melanoma and aggressive Merkel cell carcinoma necessitates improved diagnostic tools.
  • Sentinel lymph node (SLN) biopsy is crucial for staging these skin cancers.
  • Current SLN identification relies on radioactive lymphoscintigraphy, with near-infrared fluorescence imaging (NIRFI) emerging as an alternative.

Purpose of the Study:

  • To evaluate the diagnostic sensitivity of the VisionSense VS3 NIRFI device for SLN identification in patients with skin malignancies.
  • To compare the accuracy of transcutaneous NIRFI with the gold standard lymphoscintigraphy.
  • To explore the impact of SLN anatomical location and patient factors on NIRFI detection.

Main Methods:

  • Prospective diagnostic sensitivity study involving 93 patients.
  • Transcutaneous injection of indocyanine green dye followed by imaging with the VisionSense VS3 NIRFI device.
  • Comparison of NIRFI results against lymphoscintigraphy findings.

Main Results:

  • The study aims to determine the sensitivity and accuracy of the VisionSense VS3 NIRFI device.
  • Secondary analysis will assess factors influencing SLN detection rates.
  • Results will be compared against the established lymphoscintigraphy standard.

Conclusions:

  • The study anticipates that NIRFI may offer a non-radioactive, potentially more sensitive method for SLN identification.
  • Successful validation could lead to the replacement of lymphoscintigraphy in clinical practice.
  • This could improve prognostic accuracy and patient management for skin cancers.