Unique ID issued by UMIN | UMIN000024704 |
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Receipt number | R000028423 |
Scientific Title | Evaluation of the efficacy of contrast-enhanced ultrasonography for cervical lymph nodes of head and neck cancer patients |
Date of disclosure of the study information | 2016/11/03 |
Last modified on | 2019/05/08 18:37:58 |
Evaluation of the efficacy of contrast-enhanced ultrasonography for cervical lymph nodes of head and neck cancer patients
JHNCURG STUDY1
Evaluation of the efficacy of contrast-enhanced ultrasonography for cervical lymph nodes of head and neck cancer patients
JHNCURG STUDY1
Japan |
Head and Neck Cancer
Oto-rhino-laryngology |
Malignancy
NO
To evaluate the effectiveness and safety of contrast-enhancement of the lymph nodes of head and neck cancer patients who would undergo neck dissection or extirpation of the lymph nodes using two different doses of Sonazoid.
Safety,Efficacy
Exploratory
Pragmatic
Phase I
To assess the efficacy of contrast-enhanced ultrasonography compared with the B-mode ultrasonography in depicting ability of micro-vessels.
1. Evaluation of the diagnostic imaging comparing with contrast-enhanced CT or contrast-enhanced MRI.
2. Evaluation of contrast-enhanced effects.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Medicine |
Contrast-enhanced ultrasonography using micro-bubble contrast-enhanced agent.
Only one diagnostic procedure before surgery.
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients with untreated tumor (lymph node = interest lesion) depicted by other diagnostic modalities such as CT, MRI and FDG-PET or palpation and so on.
2. Patients who are subjected to undergo histopathological examination of interest lesions.
1. Allergy to eggs or egg products
2. Right to left shunts in heart or lung
3. Severe heart diseases
4. Severe lung diseases
5. Patients who plan to undergo digestive tract examination on the same day of contrast-enhanced ultrasonography
6. Pregnancy and possibility of the pregnancy or patients under the nursing
30
1st name | Kiyoto |
Middle name | |
Last name | Shiga |
Iwate Medical University, School of medicine
Department of Head and Neck Surgery
020-8505
19-1 Uchimaru, Morioka
019-651-5111
kshiga@iwate-med.ac.jp
1st name | Daisuke |
Middle name | |
Last name | Saito |
Iwate Medical University Hospital
Department of Head and Neck Surgery
020-8505
19-1 Uchimaru, Morioka
019-651-5111
daisaito@iwate-med.ac.jp
Iwate Medical University
Japan Society for the Promotion of Science
Non profit foundation
Ethics Committee Iwate Medical University School of Medicine
19-1 Uchimaru, Morioka
019-651-5111
hiroaki.kawamori@j.iwate-med.ac.jp
NO
2016 | Year | 11 | Month | 03 | Day |
Unpublished
Completed
2014 | Year | 12 | Month | 25 | Day |
2015 | Year | 02 | Month | 05 | Day |
2015 | Year | 03 | Month | 01 | Day |
2021 | Year | 12 | Month | 31 | Day |
2016 | Year | 11 | Month | 03 | Day |
2019 | Year | 05 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028423
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