Sentinel lymph node detection in skin cancer

JRCT ID: jRCTs041180008

Registered date:25/10/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: metastatic skin cancer
• Date of first enrollment: 14/07/2016
• Target sample size: 360
• Study type: Interventional

Intervention(s)

Intracutaneous injections of Technetium-99m-phytate
(6x18.5MBq) around the tumor at lymphoscintigraphy

Outcome(s)

• Primary Outcome: Identification and localization of sentinel lymph nodes

Secondary Outcome

Decision of the cut-off value of lymphatic transit rate
indicating negative nodal metastasis

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who were diagnosed with metastatic skin cancer based on histopathological examination.
2. From the results of medical history, physical findings, blood, examination, and urine test, the patients who had no serious complications that could not put them under general anesthesia or lumbar anesthesia.
3. Patients who gave written informed consent.

Exclude criteria

1. Patients who are pregnant. Patients who are breast-feeding. Patients with drug allergy to Technetium-99m
-phytate.
2. Patients who did not give written informed consent.
3. Attending physician judged that the patients were inappropriate to participate in the study.

Related Information

• Primary Sponsor: Fujiwara Masao
• Secondary ID(s): UMIN000023129