NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041180002

Registered date:21/08/2018

Detection of sentinel lymph node using contrast-enhanced ultrasonography

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedOral cancer and Oropharyngeal cancer
Date of first enrollment05/02/2019
Target sample size3
Countries of recruitment
Study typeInterventional
Intervention(s)Local injections of Sonazoid and Indigo carmine

Outcome(s)

Primary OutcomeAdverse events observed from the injection of Sonazoid until the 30 day after surgery
Secondary Outcome1) Detection of SN with contrast-enhanced ultrasonography using Sonazoid as tracer 2) Microvascular count observed in SN using Superb Microvascular Imaging (SMI)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1) 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
Exclude criteria1) 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

Related Information

Contact

Public contact
Name Naohiro WAKISAKA
Address Takaramachi13-1 Kanazawa-shi Ishikawa Ishikawa Japan 920-8641
Telephone +81-76-265-2413
E-mail wakisaka@med.kanazawa-u.ac.jp
Affiliation Kanazawa University Hospital
Scientific contact
Name Naohiro WAKISAKA
Address Takaramachi 13-1, Kanazawa-shi, Ishikawa Ishikawa Japan 920-8641
Telephone +81-76-265-2413
E-mail wakisaka@med.kanazawa-u.ac.jp
Affiliation Kanazawa University Hospital