Fluorescence Surgery for Sentinel Node Identification in Melanoma
NCT02142244 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 318
Last updated 2017-02-02
Summary
Sentinel node biopsy is a surgical procedure used to find melanoma lymph node metastasis (i.e. groin/axilla) in very early stages. This study aims to add a new technology over the standard procedure - a fluorescent contrast (indocyanine green) using special light (near infra-red) - looking for more precise diagnosis of the presence of the lymph node metastasis.
Conditions
- Melanoma
- Lymph Node Metastasis
Interventions
- PROCEDURE
-
Near infra red sentinel node biopsy
Explicated in the protocol arm
- DRUG
-
Indocyanine green
Explicated in the protocol arm
- DEVICE
-
Intraoperative Near-Infrared Imaging System
Explicated in the protocol arm
Sponsors & Collaborators
-
Barretos Cancer Hospital
lead OTHER
Principal Investigators
-
Vinicius L Vazquez, Ph.D. · Barretos Cancer Hospital
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-05-31
- Primary Completion
- 2018-12-31
- Completion
- 2021-12-31
Countries
- Brazil
Study Locations
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