UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020905 |
|---|---|
| Receipt number | R000024119 |
| Scientific Title | Proof of Concept Test on the efficacy of ultrasonography contrast agent perflurubutane in the differential diagnosis of nodular thyroid lesions |
| Date of disclosure of the study information | 2016/02/08 |
| Last modified on | 2023/10/05 14:20:54 |
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Basic information
Public title
Proof of Concept Test on the efficacy of ultrasonography contrast agent perflurubutane in the differential diagnosis of nodular thyroid lesions
Acronym
Proof of Concept Test on the efficacy of ultrasonography contrast agent perflurubutane in the differential diagnosis of nodular thyroid lesions
Scientific Title
Proof of Concept Test on the efficacy of ultrasonography contrast agent perflurubutane in the differential diagnosis of nodular thyroid lesions
Scientific Title:Acronym
Proof of Concept Test on the efficacy of ultrasonography contrast agent perflurubutane in the differential diagnosis of nodular thyroid lesions
Region
| Japan |
Condition
Condition
Nodular thyroid lesions(bening and malignant)
Classification by specialty
| Endocrinology and Metabolism | Endocrine surgery | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The current study is a preliminary study. If good results are obtained, future studies are planned to assess sensitivity and specificity of non-enhanced and contrast enhanced sonography in distinguishing between benign and malignant nodules, using fine needle aspiration cytology or tissue pathology as standards of truth.
Basic objectives2
Others
Basic objectives -Others
This is a preliminary study. Its purpose is to create diagnostic criteria of contrast enhanced ultrasonography for evaluating thyroid nodules in the efficacy study.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Contrast enhanced ultrasonography findings (will evaluate contrast enhancement patterns and vascularity patterns)
Key secondary outcomes
1.Evaluating contrast enhancement (will evaluate contrast enhanced sonography using three different ultrasound contrast agents).
2.Non-enhanced ultrasonography findings
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
After non-enhanced ultrasonography,
patients will receive a dose of the contrast agent.
One vial (16microliter) of perflubutane will be suspected in 2ml of water for intravenous injection.
0.003ml/Kg of suspension(0.024microLMB/Kg of active ingredient,perflubutane microbubles)
Interventions/Control_2
After non-enhanced ultrasonography, patients will receive a dose of the contrast agent.
One vial (16microliter) of perflubutane will be suspended in 2ml of water for intravenous injection.
0.015ml/Kg of suspension (0.12microLMB/Kg
of active ingredient,perflubutane microbubles)
Interventions/Control_3
After non-enhanced ultrasonography, patients will receive a dose of the contrast agent.
One vial (16microliter) of perflubutane will be suspended in 2ml of water for intravenous injection.
0.045ml/Kg of suspension (0.36microLMB/Kg of active ingredient, perflubutane microbubles)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with a thyroid nodule depicted on non-enhanced sonography, and have been diagnosed as either benign or malignant on fine needle aspiration cytology
2.Patients 20 years of age or older when giving consent
3.Patients without history of thyroidectomy
Key exclusion criteria
1.Patients with a history of hypersensitivity to contents of perflurubutane
2.Patients who are pregnant,possibly pregnant,or nursing
3 Patients with allergies to eggs or egg products
4.Patients with pulmonary arterovenous shunts in the heart or lungs
5.Patients with severe heart or lung disease
6.Patients receiving drug therapy (such as chemotherapy) or radiotherapy for cancer,or will receive such therapy within two days of receiving contrast
7.Patients considered inappropriate for achieving the purpose this clinical study by the principal investigator or investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Hirasawa |
Organization
Gunma University Hospital
Division name
department of nuclear medecine
Zip code
Address
3-39-15 showa-machi maebashi gunnma
TEL
027-220-8612
h.hirasawa@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromi Hirasawa |
Organization
Gunma University Hospital
Division name
department of nuclear medecine
Zip code
Address
3-39-15 showa-machi maebashi gunnma
TEL
027-220-8612
Homepage URL
h.hirasawa@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
department of nuclear medecine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 05 | Day |
Last modified on
| 2023 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024119
