drugset / Trial / NCT02142244
Fluorescence Surgery for Sentinel Node Identification in Melanoma
NaSingle-groupOpen-labelDiagnostic
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.
Timeline
- Start
- 2014-05
- Primary completion
- 2018-12
- Completion
- 2021-12
Publications
- Background Tanaka E, Choi HS, Fujii H, Bawendi MG, Frangioni JV. Image-guided oncologic surgery using invisible light: completed pre-clinical development for sentinel lymph node mapping. Ann Surg Oncol. 2006 Dec;13(12):1671-81. doi: 10.1245/s10434-006-9194-6. Epub 2006 Sep 29.
- Background Frangioni JV. New technologies for human cancer imaging. J Clin Oncol. 2008 Aug 20;26(24):4012-21. doi: 10.1200/JCO.2007.14.3065.
- Background Namikawa K, Yamazaki N. Sentinel lymph node biopsy guided by indocyanine green fluorescence for cutaneous melanoma. Eur J Dermatol. 2011 Mar-Apr;21(2):184-90. doi: 10.1684/ejd.2010.1237.
- Background van der Vorst JR, Schaafsma BE, Verbeek FP, Swijnenburg RJ, Hutteman M, Liefers GJ, van de Velde CJ, Frangioni JV, Vahrmeijer AL. Dose optimization for near-infrared fluorescence sentinel lymph node mapping in patients with melanoma. Br J Dermatol. 2013 Jan;168(1):93-8. doi: 10.1111/bjd.12059.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Indocyanine Green | Diagnostic / imaging agent | 0.8 mg | Other |