Lymph Node Metastasis, Melanoma
Conditions
Keywords
Sentinel node biopsy, Near infra red light, Indocyanine green, micrometastasis
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.
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.
Interventions
PROCEDURENear infra red sentinel node biopsy
Explicated in the protocol arm
DRUGIndocyanine green
Explicated in the protocol arm
DEVICEIntraoperative Near-Infrared Imaging System
Explicated in the protocol arm
Sponsors
Barretos Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients eligible for sentinel node biopsy in standard care
Exclusion criteria
* Previous neoplasia * Previous surgery or scar in the lymph node basin or primary tumor, except primary tumor biopsy * Local recurrence * Hypersensibility or allergy history to indocyanine or Iodine-based contrast media
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Outcome results
None listed