JRCT ID: jRCTs021180036
Registered date:25/03/2019
Sentinel lymph node detection of the head and neck cancer by contrast-enhanced ultrasonography
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | head and neck cancer |
Date of first enrollment | 15/12/2015 |
Target sample size | 50 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | intra-venous injection of contrast-medium |
Outcome(s)
Primary Outcome | Detection rate of sentinel lymph node by ultrasonography using contrast-medium |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include 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 |
Exclude 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 |
Related Information
Primary Sponsor | Shiga kiyoto |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Daisuke Saito |
Address | 2-1-1, Idaidori, Yahabacho, Shiwa-gun, Iwate Iwate Japan 028-3695 |
Telephone | +81-19-613-7111 |
kshiga@iwate-med.ac.jp | |
Affiliation | Iwate Medical University |
Scientific contact | |
Name | kiyoto Shiga |
Address | 2-1-1, Idaidori, Yahabacho, Shiwa-gun, Iwate Iwate Japan 028-3695 |
Telephone | +81-19-613-7111 |
kshiga@iwate-med.ac.jp | |
Affiliation | Iwate Medical University |