Fluorescence Surgery for Sentinel Node Identification in Melanoma
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The main objectives of this study is perform a new technique added to the usual procedure for sentinel lymph node biopsy for cutaneous melanoma. The fluorescence surgery consists in a injection of indocyanine green around the primary tumor, or, when already excised (excisional biopsy), the biopsy site at the beginning of the surgery. Patient performs, in a standard fashion, the lymph scintigraphy prior the surgery and is injected at the same time a blue die similarly the indocyanine green. Immediately after the indocyanine infusion, the injection site is massaged and a near infra red light (NIR) is focused over it. An appropriated infra red camera is positioned over the lymphatic pathway, searching for the fluorescence and localizing the sentinel node at the basin. The skin is opened and the sentinel node is resected. The success or not in localizing the sentinel node is pointed and the standard techniques are applied - gamma probe and surgical location of a blue lymph node. All sentinel node characteristics are noted as number, which technic identified it, time, location. Later information will be gathered as histological status, surgical complications, recurrence and survival.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Near infra red sentinel node biopsy Sentinel node biopsy adding indocyanine green injection at the tumor/biopsy site during the surgical procedure to the standard technique (blue die and lymph scintigraphy) and near infra red light for fluorescence. The indocyanine green saline solution - 5mg diluted in 10ml. will be injected in 4 points around the biopsy site - 4ml each - total 0.8mg - single procedure.Near infra red lens and camera will be used to detect the fluorescence and localize the sentinel node for biopsy. |
Procedure: Near infra red sentinel node biopsy
Explicated in the protocol arm
Other Names:
Drug: Indocyanine green
Explicated in the protocol arm
Device: Intraoperative Near-Infrared Imaging System
Explicated in the protocol arm
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Sensibility of the sentinel node biopsy [Time of surgery]
The successful rate of the sentinel node localization and biopsy. The standard technique and the experimental one will be assessed
Secondary Outcome Measures
- Specificity of the sentinel node biopsy [60 months]
The false negative sentinel node biopsy rate. The proportion of patients submitted to the procedure with histological negative biopsy, presenting lymph node metastasis at follow up.
Other Outcome Measures
- Overall survival [60 months]
- Disease free survival [60 months]
Presence and time to disease recurrence or not
- Specific cancer survival [60 months]
Specific melanoma survival
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients eligible for sentinel node biopsy in standard care
Exclusion Criteria:
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Previous neoplasia
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Previous surgery or scar in the lymph node basin or primary tumor, except primary tumor biopsy
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Local recurrence
-
Hypersensibility or allergy history to indocyanine or Iodine-based contrast media
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Barretos Cancer Hospital | Barretos | SP | Brazil | 14784400 |
Sponsors and Collaborators
- Barretos Cancer Hospital
Investigators
- Principal Investigator: Vinicius L Vazquez, Ph.D., Barretos Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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.
- 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. Epub 2006 Sep 29.
- 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.
- BCHNIR01