NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001162

Registered date:20/05/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedMalignant melanoma
Date of first enrollment2008/05/01
Target sample size200
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeSafety of sentinel node biopsy
Secondary OutcomeEfficacy

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaPatients 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

Contact

public contact
Name Hisashi Uhara
Address Asahi 3-1-1, Matsumoto 390-8621 Japan
Telephone 0263-37-2647
E-mail
Affiliation School of Medicine, Shinsu University Department of Dermatology
scientific contact
Name Toshiaki Saida
Address Asahi 3-1-1, Matsumoto 390-8621 Japan
Telephone 0263-37-2647
E-mail
Affiliation School of Medicine, Shinsu University Department of Dermatology