UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021721 |
|---|---|
| Receipt number | 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 | 2025/04/30 14:53:57 |
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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
| Obstetrics 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 | Hitoshi |
| Middle name | |
| Last name | Niikura |
Organization
Tohoku University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7254
niikura@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Asami |
| Middle name | |
| Last name | Toki |
Organization
Tohoku University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7254
Homepage URL
asa_tannpopo_pon@yahoo.co.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
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
Tohoku University Hospital
Address
Seiryo-machi 1-1, Sendai city , Miyagi, Japan
Tel
022-717-7254
asami.toki@med.tohoku.ac.jp
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
https://www.umbjournal.org/article/S0301-5629(21)00161-7/abstract
Publication of results
Published
Result
URL related to results and publications
https://www.umbjournal.org/article/S0301-5629(21)00161-7/abstract
Number of participants that the trial has enrolled
37
Results
We examined 74 SLNs of 26 patients with endometrial cancer and 11 patients with cervical cancer. Seventeen positive and 40 negative SLNs were evaluable. Margin and enhancement patterns, PI min, PI ratio and PI difference revealed significant differences.The AUCs were 0.64, 0.82 and 0.83, respectively. The most effective PI ratio from the AUC was 1.3, and the PI difference from the AUC was 20 .
Results date posted
| 2025 | Year | 04 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We examined 74 SLNs of patients with endometrial cancer (n = 26) and cervical cancer (n = 11).
Participant flow
Patients underwent US and CEUS followed by SLN biopsy; US and CEUS results were evaluated visually and quantitatively and compared between pathological metastasis-negative and -positive groups. To support CEUS results, the microvessel density of SLNs was evaluated immunohistochemically. Seventeen positive and 40 negative SLNs were evaluable.
Adverse events
No significant adverse events were observed.
Outcome measures
Seventeen positive and 40 negative SLNs were evaluable. Margin and enhancement patterns by visual assessment revealed significant differences. In quantitative TIC analyses, the weakest peak intensities ;PI min, PI ratio and PI difference indicated significant differences. The AUCs were 0.64, 0.82 and 0.83, respectively. The most effective PI ratio from the AUC was 1.3, and the PI difference from the AUC was 20 . Microvessel density was significantly lower in metastatic lesions than in other areas.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2021 | 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 | 03 | Month | 31 | Day |
Last modified on
| 2025 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024995
