Detection of sentinel lymph node using contrast-enhanced ultrasonography

Phase 1

• Conditions: Oral cancer and Oropharyngeal cancer; Other cancer

• Registration Number: JPRN-jRCTs041180002
• Lead Sponsor: WAKISAKA Naohiro

Brief Summary

In this clinical trial, no adverse event was observed, and detection of Sentinel Node was possible.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-21
• Study Completion: 2019-04-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1) Patients of oral or oropharyngeal cancer with clinical cN0 disease using neck computed tomography
2) Patients without the histories of previous treatment for oral or oropharyngeal cancer
3) Age, at the time of the consent, is 20 years or older
4) The patient with a documented informed consent for the participation to this study from their own free will

Exclusion Criteria

1) The case with a history of irradiation to the neck
2) The patient who participated in other clinical trials within three months
3) Allergic history for Sonazoid or Indigo carmine
4) Allergic history for egg
5) A woman with possibility of the pregnancy or the intention, a pregnant woman or lactation
6) The patient in whom a principle investigator or members judged to be inappropriate as a subject

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events observed from the injection of Sonazoid until the 30 day after surgery

Secondary Outcome Measures

Name	Time	Method
1) Detection of SN with contrast-enhanced ultrasonography using Sonazoid as tracer<br>2) Microvascular count observed in SN using Superb Microvascular Imaging (SMI)