Detection of sentinel lymph node using contrast-enhanced ultrasonography

JRCT ID: jRCTs041180020

Registered date:20/12/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Oral Cancer
• Date of first enrollment: 06/04/2017
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Local injections of Sonazoid and Indigo carmine

Outcome(s)

• Primary Outcome: Evaluation of safety and feasibility of detection of sentinel node using contrast-enhanced ultrasonography (CEUS) and vascular imaging

Secondary Outcome

SN detection rate with CEUS
Sensitivity, specificity, negative-predictive ratio, positive-predictive ratio, accuracy, and false-negative ratio of SN detection
Sensitivity, specificity, negative-predictive ratio, positive-predictive ratio, accuracy, and false-negative ratio of vascular Imaging
Recurrence-free Survival

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include 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
• Exclude 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

Related Information

• Primary Sponsor: WAKISAKA Naohiro
• Secondary ID(s): UMIN000026698