Evaluation of safety and usefulness of sentinel node biopsy in the patients with malignant melanoma

UMIN ID: UMIN000001162

Registered date:20/05/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Malignant melanoma
• Date of first enrollment: 2008/05/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Patients undergo cutaneous lymphoscintigraphy with radiopharmaceuticals, either one day before or on the day of the operative procedure. Using the lymphoscintigraphic images, the skin site corresponding to the highest accumulation of radioparticles is identified and marked. At the time of surgery, patent blue violet or diagnogreen is injected intradermally at the primary tumor site. An incision is preformed on the skin site which is most radioactive by gamma-probe. The lymph node(s) stained with the blue dye (patentblue) or fluorescence (diagnogreen) and most radioactive is identified and excised. The excised node(s) is processed for histopathologic examination and the presence of metastases is evaluated using sections stained with hematoxylin and eosin (H&E). If metastases are not detected by H&E staining of the first section, then additional sections are cut from the bivalved lymph nodes and stained with the murine monoclonal antibodies Mart1 (MelanA), HMB-45 and S-100 for immunohistochemical evaluation. If metastases are detected in the sentinel node(s), then curative lymph node dissection is performed.

Outcome(s)

• Primary Outcome: Safety of sentinel node biopsy
• Secondary Outcome: Efficacy

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients with distant metastasis. Patients with severe liver dysfunction. Pregnant, possible pregnant or feeding women. Patients without informed consent. Patients regarded as not adequate for this study by physicians.

Related Information

• Primary Sponsor: School of Medicine, Shinsu University
• Source(s) of Monetary Support: The health, and labour science research grants from Ministry of Health, Labour and Welfare.