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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021721
Receipt No. R000024995
Scientific Title Quantitative analysis of microbubble-enhanced ultrasound for diagnosis of sentinel lymph node metastasis of uterine cervical cancer and uterine body cancer
Date of disclosure of the study information 2016/04/01
Last modified on 2016/05/01

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Basic information
Public title Quantitative analysis of microbubble-enhanced ultrasound for diagnosis of sentinel lymph node metastasis of uterine cervical cancer and uterine body cancer
Acronym Diagnosis of sentinel lymph node metastasis using microbubble-enhanced ultrasound of uterine cancer
Scientific Title Quantitative analysis of microbubble-enhanced ultrasound for diagnosis of sentinel lymph node metastasis of uterine cervical cancer and uterine body cancer
Scientific Title:Acronym Diagnosis of sentinel lymph node metastasis using microbubble-enhanced ultrasound of uterine cancer
Region
Japan

Condition
Condition uterine cervical cancer, uterine body cancer
Classification by specialty
Obsterics and gynecology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of quantitative analysis of contrast-enhanced ultrasound imaging to detect LN metastasis in cervical cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes quantitative analysis of contrast-enhanced ultrasound imaging for sentinel lymph node
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 After detection of sentinel lymph node, we inject SONAZOID for injection by intravenous and get the enhanced ultrasound imaging.
Usual dosage for an adult is 0.015mL/kg body weight in a single administration.
Only operation day.
Interventions/Control_2
Interventions/Control_3
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
75 years-old >=
Gender Female
Key inclusion criteria Stage 1 and 2A of uterine cervical cancer or Stage 1 and 2 of uterine body cancer.
patients scheduled operation and examination of sentinel lymph node.
Description and consent.
Key exclusion criteria Right-left shunt of heart or lung
Egg allergy
Pregnant woman
Hypersensitivity of sonazoid
Severe heart disease or lung disease
Unstable psychological symptom
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Niikura
Organization Tohoku University Hospital
Division name Department of Obstetrics and Gynecology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL 022-717-7254
Email niikura@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Niikura
Organization Tohoku University Hospital
Division name Department of Obstetrics and Gynecology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL 022-717-7254
Homepage URL
Email niikura@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

Funding Source
Organization Tohoku University Hospital
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
Email

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 04 Month 01 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 Enrolling by invitation
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 31 Day
Last modified on
2016 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024995

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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