Ultra-low-dose Whole-body CT Using AI-based CT Reconstruction in Patients With Multiple Myeloma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 19 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - patients who do not agree to the protocol.
  • - non-Korean patients.
- pregnancy

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05577884
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Seoul National University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Hee-Dong Chae, MD
Principal Investigator Affiliation Seoul National University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Korea, Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Arms & Interventions

Arms

: Multiple myeloma

Patients with suspicion of multiple myeloma and scheduled for CT

Interventions

Diagnostic Test: - noncontrast-enhanced whole-body CT

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 03080

Site Contact

Hee-Dong Chae, MD

hdchae02@gmail.com

+82-2-2072-4209