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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Near infra red sentinel node biopsy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near infra red sentinel node biopsy | Procedure | Explicated in the protocol arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensibility of the sentinel node biopsy | The successful rate of the sentinel node localization and biopsy. The standard technique and the experimental one will be assessed | Time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of the sentinel node biopsy | 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. | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 60 months | |
| Disease free survival | Presence and time to disease recurrence or not | 60 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vinicius L Vazquez, Ph.D. | Barretos Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barretos Cancer Hospital | Recruiting | Barretos | São Paulo | 14784400 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17009138 | 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. | |
| 18711192 | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 7, 2023 | |
| Reset | Nov 16, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 7, 2023 | Nov 16, 2023 |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D008207 | Lymphatic Metastasis |
| D061206 | Neoplasm Micrometastasis |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D021701 | Sentinel Lymph Node Biopsy |
| D005453 | Fluorescence |
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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| Indocyanine green | Drug | Explicated in the protocol arm |
|
| Intraoperative Near-Infrared Imaging System | Device | Explicated in the protocol arm |
|
|
| Specific cancer survival |
Specific melanoma survival |
| 60 months |
| 21498148 | 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. |
| 23078649 | 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. |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008197 | Lymph Node Excision |
| D008919 | Investigative Techniques |
| D049449 | Luminescence |
| D008027 | Light |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D055620 | Optical Phenomena |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |