Multiple MyelomaNCT05577884
Ultra-low-dose Whole-body CT Using AI-based CT Reconstruction in Patients With Multiple Myeloma
An observational study of Multiple Myeloma, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- noncontrast-enhanced whole-body CT
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Oct 2022to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are referred to Hemoatooncology department with suspicion of multiple myeloma
Who may be able to join
- 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
Who cannot join
- patients who do not agree to the protocol
- non-Korean patients
- pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Hee-Dong Chae, MD, +82-2-2072-4209, hdchae02@gmail.com
Hee-Dong Chae, MD
About this study
Official title: 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
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.
- Conditions
- Multiple Myeloma
- Being tested
- noncontrast-enhanced whole-body CT
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noncontrast-enhanced whole-body CTDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Multiple myeloma | Patients with suspicion of multiple myeloma and scheduled for CT Receives: Diagnostic Test: noncontrast-enhanced whole-body CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast-to-noise ratio
Contrast-to-noise ratio (CNR) of the vertebral body and paraspinal muscle obtained at L1 vertebra level
Measured: 3 months after the CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start6 Oct 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Dong Chae, Seoul National University Hospital
- Investigators
- Hee-Dong Chae, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577884
- Sponsor's protocol ID
- SNUH-2021-4317
- Status last verified
- Nov 2022
- First submitted
- 5 Oct 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05577884
- Acronym / sponsor ID
- SNUH-2021-4317
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple myeloma | – | Diagnostic Test: noncontrast-enhanced whole-body CTPatients with suspicion of multiple myeloma and scheduled for CT |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are referred to Hemoatooncology department with suspicion of multiple myeloma
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- patients who do not agree to the protocol
- non-Korean patients
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| noncontrast-enhanced whole-body CTnoncontrast-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. | Diagnostic test | Multiple myeloma |
Primary outcome
Contrast-to-noise ratio
Time frame: 3 months after the CT scan
Contrast-to-noise ratio (CNR) of the vertebral body and paraspinal muscle obtained at L1 vertebra level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
RecruitingPhase 1/2
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
Multiple Myeloma
RecruitingPhase 1
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Relapsed Multiple Myeloma, Refractory Multiple Myeloma
RecruitingPhase 1
A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
Multiple Myeloma (MM)
Active, not recruiting
Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring
Breast Cancer, Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee-Dong Chae, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee-Dong Chae, MD (82-2-2072-4209, hdchae02@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast-to-noise ratio (time frame: 3 months after the CT scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.