UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032322 |
|---|---|
| Receipt number | R000036846 |
| Scientific Title | Accuracy of T1 measurements for the uterus with B1 Correction |
| Date of disclosure of the study information | 2018/04/20 |
| Last modified on | 2026/06/04 08:20:06 |
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Basic information
Public title
Accuracy of T1 measurements for the uterus with B1 Correction
Acronym
Accuracy of T1 measurements for the uterus with B1 Correction
Scientific Title
Accuracy of T1 measurements for the uterus with B1 Correction
Scientific Title:Acronym
Accuracy of T1 measurements for the uterus with B1 Correction
Region
| Japan |
Condition
Condition
Uterine fibroids
Classification by specialty
| Obstetrics and Gynecology | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate an accuracy of T1 measurements for uterine MR Imaging at 3 T using variable flip angle methods with B1 inhomogeneity correction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess T1 measurement errors for uterine MRI using variable flip angle methods with and without B1 inhomogeneity correction
Key secondary outcomes
Correlation between inversion recovery(IR)methods and variable flip angle methods
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
T1 measurements using variable flip angle methods with B1 correction
Period:1 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
| 85 | years-old | > |
Gender
Female
Key inclusion criteria
No history of surgery for pelvic diseases in the past
Completed obtaining informed consent for voluntary participation in this study
Key exclusion criteria
History of surgery for pelvic diseases in the past
Subject determined inappropriate for voluntary by attending doctor
Pregnant or breast-feeding
Claustrophobia
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Shunta |
| Middle name | |
| Last name | Ishitoya |
Organization
Asahikawa Medical University
Division name
Department of Radiology
Zip code
078-8510
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
TEL
0166-68-2572
ishitoya@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Sadahiro |
| Middle name | |
| Last name | Nakagawa |
Organization
Asahikawa Medical University Hospital
Division name
Section of Radiological Technology
Zip code
078-8510
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
TEL
0166-65-3430
Homepage URL
nakasada@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University Research Support Section
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
Tel
0166-68-2297
rs-kk.g@asahikawa-med.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
旭川医科大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 20 | Day |
Related information
URL releasing protocol
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0297402
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0297402
Number of participants that the trial has enrolled
63
Results
The mean inter- and intraobserver CoV of the qT1 values for semiautomatic ROI placement was significantly lower than those for manual ROI placement (p < 0.05 and p < 0.01, respectively). ICCs for semiautomatic ROI placement were greater than those for manual ROI placement. Further, the mean inter- and intraobserver errors for semiautomatic ROI placement were significantly lower than those for manual ROI placement (p < 0.05 and p < 0.01, respectively).
Results date posted
| 2026 | Year | 06 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 01 | Month | 26 | Day |
Baseline Characteristics
Healthy female volunteers.
Participant flow
We received a contact from someone who saw the poster in the hospital and expressed interest in participating, so we coordinated the schedule and performed the examination.
Adverse events
non
Outcome measures
This study recruited 23 healthy female volunteers. Data with variable flip angle and inversion recovery were acquired using 3Dspoiled gradient echo and spin echo sequences, respectively. T1 maps were generated with VFA. Manual and semiautomatic ROI placements were independently conducted. Mean qT1 values were calculated from the T1 maps using the corresponding pixel values of the myometrial ROI. Inter and intraobserver reproducibility of qT1 values was investigated. The inter and intraobserver reproducibility of qT1 values was evaluated by calculating the coefficient of variation. Further, reproducibility was evaluated with inter and intraobserver errors and intraclass correlation coefficients. Bland Altman analysis was utilized to compare the results, estimate bias, and determine the limits of agreement.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Published: January 26, 2024
Management information
Registered date
| 2018 | Year | 04 | Month | 19 | Day |
Last modified on
| 2026 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036846
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/10/21 | 研究実施計画書 2019 02 22.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2019/10/21 | 201900928.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/10/21 | 20191015 uno.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/36846
