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Lymph Node Identification in Skin Malignancy Using ICG Transcutaneously Study

NCT03545334 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2022-12-12

No results posted yet for this study

Summary

A diagnostic sensitivity study comparing intradermal indocyanine green (ICG) and near infrared fluorescence imaging (NIRFI) with intradermal technetium 99m and traditional lymphoscintigraphy (LS) for transcutaneous identification of sentinel lymph nodes (SLN) in malignant melanoma - a prospective Phase II clinical study in a single center.

Conditions

Interventions

DIAGNOSTIC_TEST

Visionsense™ VS3 - Stereoscopic High Definition Visualisation System (VS3-3DHD)

Injection of ICG intradermally around the scar of the primary excision of the tumour and transcutaneous assessment of fluorescence with the VS3-3DHD camera (Visionsense™ VS3 - Stereoscopic High Definition Visualisation System ).

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Mihai A. Constantinescu, Professor · Clinic for Plastic and Reconstructive Surgery, Inselspital Bern, Switzerland

  • Radu Olariu, MD · Clinic for Plastic and Reconstructive Surgery, Inselspital Bern, Switzerland

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2020-03-31
Completion
2020-10-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03545334 on ClinicalTrials.gov