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Clinical Trials/JPRN-jRCTs021180036
JPRN-jRCTs021180036
Completed
Phase 1

Sentinel lymph node detection of the head and neck cancer patients by ultrasonography using micro-bubble contrast-medium-Phase I study of the efficacy of sonazoid targeting head and neck cancers

Shiga kiyoto0 sites3 target enrollmentStarted: March 25, 2019Last updated:

Overview

Phase
Phase 1
Status
Completed
Sponsor
Shiga kiyoto
Enrollment
3

Overview

Brief Summary

This study aimed to detect sentinel lymph nodes by contrast-enhanced ultrasonography. Sentinel lymph node was detectable by contrast-enhanced ultrasonography in some of the patients. However, as the background shadow was very high in other patients, detection of the sentinel lymph nodes was not possible..

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 20age old to ot applicable (—)
Sex
All

Inclusion Criteria

  • 1\. head and neck cancer patients with untreated lymph node metastasis in the neck
  • 2\. patients with the tumor which will be resected and diagnosed by histopathological examination
  • 3\. patients more than 20 years old

Exclusion Criteria

  • 1\. patients with allergy to egg or ingredient made from egg
  • 2\. patients with arterio\-venous shunt in heart or lung
  • 3\. patients with severe heart disease
  • 4\. patients with severe lung disease
  • 5\. patients who will undergo laparoscopic examination or digestive tract examination using effervescent agent on the same day undergoing this examination
  • 6\. pregnant or possible pregnant patients and breast\-feeding patients
  • 7\. patients who can not receive contrast\-enhanced MRI or CT examination
  • 8\. patients whose target tumor are recurrent diseases
  • 9\. patients who received or will be received contrast\-enhanced media (Iode media, MRI media, other contrast\-enhanced media for ultrasonography etc.) during the day before and after the day of sonazoid injection
  • 10\. patients who responsible doctors recognize inappropriate for this study

Investigators

Sponsor
Shiga kiyoto

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