Sentinel lymph node biopsy feasibility study in patients with primary cutaneous melanoma

Sponsor not defined - Record supplied by Institute of Cancer Research0 个研究点目标入组 120 人开始时间: 2005年1月10日最近更新: 2018年5月28日

适应症

试验速览

暂无简介。

•1. Patients must have clinical stage I or II invasive cutaneous melanoma with Breslow thickness greater than 1.0 mm and be suitable for lymphadenectomy surgery
•2. The primary site must be on the trunk, limbs or digits. Patients with a primary melanoma involving the ear, eye or mucous membranes are not eligible.
•3. Primary excision must have been within 90 days prior to the initial clinic visit
•4. Subjects must be at least 18 years old
•5. Karnovsky performance status greater than 70%
•6. Women of childbearing age must have a negative pregnancy test
•7. Subjects must voluntarily sign an informed consent form before study entry and agree to complete follow-up assessments
•8. Adequate bone marrow, renal and hepatic function

•1. Wide local excision of the primary tumour with greater than 1 cm excision margins before SLNB. Patients may have SLNB and still be eligible for excision margin studies after SLNB.
•2. Clinical evidence of satellite, in-transit, regional nodal or distant metastases
•3. A second primary invasive melanoma
•4. Any malignancy in the past 5 years, except squamous cell carcinoma of the skin, basal cell carcinoma, in situ carcinoma of the uterine cervix, or Stage I laryngeal carcinoma
•5. Prior surgery in the region of the primary draining nodal basin that would disrupt normal lymphatic drainage patterns
•6. Previous chemotherapy, immunotherapy or radiation therapy
•7. Pregnancy or breast feeding
•8. Known hypersensitivity to 99mTc-nanocolloid or patent blue dye.
•9. History of any severe medical condition that is a significant risk to the participant leading to a life expectancy of less than 10 years prior to diagnosis of melanoma

发起方

Sponsor not defined - Record supplied by Institute of Cancer Research