JRCT ID: jRCTs041180002
Registered date:21/08/2018
Detection of sentinel lymph node using contrast-enhanced ultrasonography
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Oral cancer and Oropharyngeal cancer |
Date of first enrollment | 05/02/2019 |
Target sample size | 3 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Local injections of Sonazoid and Indigo carmine |
Outcome(s)
Primary Outcome | Adverse events observed from the injection of Sonazoid until the 30 day after surgery |
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Secondary Outcome | 1) 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 |
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Age maximum | Not applicable |
Gender | Both |
Include 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 |
Exclude 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 |
Related Information
Primary Sponsor | WAKISAKA Naohiro |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | Nil known |
Contact
Public contact | |
Name | Naohiro WAKISAKA |
Address | Takaramachi13-1 Kanazawa-shi Ishikawa Ishikawa Japan 920-8641 |
Telephone | +81-76-265-2413 |
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 |
wakisaka@med.kanazawa-u.ac.jp | |
Affiliation | Kanazawa University Hospital |