Detection of sentinel lymph node using contrast-enhanced ultrasonography

Phase 1

• Conditions: Oral Cancer

• Registration Number: JPRN-jRCTs041180020
• Lead Sponsor: WAKISAKA Naohiro

Brief Summary

1) In the previous report, the sentinel lymph node metastasis-positive ratio were about 20%. However, in this study, the ratio was 0%. 2) We could not tconfirm that the resected lymph node was actual sentinel lymph node. Therefore, we judged that picking-up of sentinel lymph node was difficult in our method. Thus we stopped this study.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-20
• Study Completion: 2021-11-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1) Patients of oral cancer with clinical cN0 disease using neck computed tomography 2) Patients without the histories of previous treatment for oral cancer 3) Age, at the time of the consent, is 18 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 patient who had recurrent disease of oral cancer 2) The case with a history of irradiation to the neck 3) The patient who had previous treatment such as chemotherapy and/or irradiation before surgery 4) Allergic history for Sonazoid or Indigo carmine 5) Allergic history for egg 6) A woman with possibility of the pregnancy or the intention, a pregnant woman or lactation 7) 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
Evaluation of safety and feasibility of detection of sentinel node using contrast-enhanced ultrasonography (CEUS) and vascular imaging

Secondary Outcome Measures

Name	Time	Method
SN detection rate with CEUS<br>Sensitivity, specificity, negative-predictive ratio, positive-predictive ratio, accuracy, and false-negative ratio of SN detection<br>Sensitivity, specificity, negative-predictive ratio, positive-predictive ratio, accuracy, and false-negative ratio of vascular Imaging<br>Recurrence-free Survival