UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056280 |
|---|---|
| Receipt number | R000064307 |
| Scientific Title | An Exploratory Study on the Characteristics of Multiple Types of Cortical Bone Imaging in the Spinal Region |
| Date of disclosure of the study information | 2024/11/27 |
| Last modified on | 2025/11/28 10:39:14 |
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Basic information
Public title
An Exploratory Study on the Characteristics of Multiple Types of Cortical Bone Imaging in the Spinal Region
Acronym
An Exploratory Study on the Characteristics of Multiple Types of Cortical Bone Imaging in the Spinal Region
Scientific Title
An Exploratory Study on the Characteristics of Multiple Types of Cortical Bone Imaging in the Spinal Region
Scientific Title:Acronym
An Exploratory Study on the Characteristics of Multiple Types of Cortical Bone Imaging in the Spinal Region
Region
| Japan |
Condition
Condition
None in particular
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratively evaluate the characteristics, appropriate clinical applications, and pitfalls of various cortical bone imaging techniques in the spinal region.
Basic objectives2
Others
Basic objectives -Others
Traditionally, the evaluation of cortical bone and calcifications has been challenging with MRI due to their extremely short T2 values, and CT has been the primary modality used. However, recent advancements have introduced cortical bone imaging (CT-like imaging) techniques, including zero TE, ultra-short TE, 3D multi-gradient echo, and AI-driven MRI-based synthetic CT, enabling cortical bone assessment using MRI. This development offers the potential to simultaneously evaluate soft tissues and bone morphology with MRI alone, promising improved clinical efficiency and economic benefits. However, the characteristics, optimal applications, and pitfalls of each technique remain unclear, limiting their clinical adoption. This study aims to capture spinal region images using these cortical bone imaging techniques and conduct an exploratory evaluation of their features and appropriate clinical applications.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
In newly acquired spinal MRI cortical bone imaging, a visual scaling evaluation will be performed by multiple reviewers. This evaluation will assess the presence and extent of lesions, anatomical structures, artifacts, and noise levels. The results will be compared with CT examinations of the same patients and the same regions.
Key secondary outcomes
To support the primary evaluation metrics, the signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) will be calculated for each sequence, and these quantitative values will be compared and analyzed.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
MRI bone cortical imaging
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients for whom spinal MRI was clinically indicated and who had previously undergone CT imaging of the same region.
Patients for whom the target cortical bone imaging was successfully performed without issues.
Key exclusion criteria
- Individuals under 18 years of age
- Individuals unsuitable for MRI examinations (e.g., those with pacemakers or other metallic implants, or those with claustrophobia)
- Individuals who do not consent to participate in the study
- Pregnant individuals or those who may be pregnant
- Other individuals deemed unsuitable by the principal investigator or co-investigators
Target sample size
393
Research contact person
Name of lead principal investigator
| 1st name | Taiki |
| Middle name | |
| Last name | Nozaki |
Organization
Keio University, School of Medicine
Division name
Department of Radiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
nozaki@rad.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Hase |
Organization
Keio University, School of Medicine
Division name
Department of Radiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
hase@rad.med.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
keio@esct.bvits.com
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
| 2024 | Year | 11 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 11 | Month | 27 | Day |
Last modified on
| 2025 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064307
