Ultra-low-dose Whole-body CT Using AI-based CT Reconstruction in Patients With Multiple Myeloma
Noise Reduction and Image Quality Improvement in Ultra-low-dose Whole-body CT Scans Using AI-based CT Reconstruction Program (ClariCT.AI) in Patients With Multiple Myeloma: A Prospective, Single-center Study
1 other identifier
observational
30
1 country
1
Brief Summary
This prospective study aims to perform intra-individual comparison of the image quality between ultra-low-dose whole-body CT with deep learning reconstruction and conventional low-dose whole-body CT with iterative reconstruction in patients with suspected multiple myeloma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2022
CompletedStudy Start
First participant enrolled
October 6, 2022
CompletedFirst Posted
Study publicly available on registry
October 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedNovember 8, 2022
November 1, 2022
3 months
October 5, 2022
November 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Contrast-to-noise ratio
Contrast-to-noise ratio (CNR) of the vertebral body and paraspinal muscle obtained at L1 vertebra level
3 months after the CT scan
Other Outcomes (7)
Noise
3 months after the CT scan
Signal-to-noise ratio (SNR)
3 months after the CT scan
Edge rising distance
3 months after the CT scan
- +4 more other outcomes
Study Arms (1)
Multiple myeloma
Patients with suspicion of multiple myeloma and scheduled for CT
Interventions
noncontrast-enhanced low-dose whole-body CT using dual-source CT scanner using A-tube (75% radiation) and B-tube (25% radiation). * conventional low-dose CT data (A +B tubes, 100% dose) are reconstructed with iterative reconstruction * ultra-low dose CT data (B-tube only, 25% dose) are reconstructed with deep learning commercially available software.
Eligibility Criteria
Patients who are referred to Hemoatooncology department with suspicion of multiple myeloma
You may qualify if:
- signed informed consent
- patients with suspected multiple myeloma and scheduled for noncontrast-enhanced low-dose whole-body CT
- patients who have no previous history of chemotherapy for multiple myeloma
You may not qualify if:
- patients who do not agree to the protocol
- non-Korean patients
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hee-Dong Chae, MD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
October 5, 2022
First Posted
October 13, 2022
Study Start
October 6, 2022
Primary Completion
December 31, 2022
Study Completion
February 28, 2023
Last Updated
November 8, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share