Sentinel lymph node detection in skin cancer

Phase 2

• Conditions: metastatic skin cancer

• Registration Number: JPRN-jRCTs041180008
• Lead Sponsor: Fujiwara Masao

Brief Summary

Sentinel lymph node (SLN) retrieval using radioisotopes was an effective and safe method. Lymphatic transit rate (LTR) values of metastatic lymph nodes were significantly higher than those of non-metastatic SLNs at all sites, and low LTR values suggested the possibility of negative nodes. A cutoff value was proposed as a guide for negative metastasis.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-25
• Study Completion: 2020-01-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 104

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification and localization of sentinel lymph nodes

Secondary Outcome Measures

Name	Time	Method
Decision of the cut-off value of lymphatic transit rate <br>indicating negative nodal metastasis