ClinicalTrials.gg
Status unknownNCT05577884Updated Nov 8, 2022

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

An observational study in Multiple Myeloma, sponsored by Seoul National University Hospital. Status unknown at 1 site in South Korea. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by Seoul National University Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
19 Years to 85 Years
Sex
All
01

Study 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.

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Conditions studied

  • Multiple Myeloma

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03

In context

Multiple Myeloma

3,713 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.

This study's planned enrollment of 30 is below the median of 145 across 482 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,898 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who are referred to Hemoatooncology department with suspicion of multiple myeloma

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • patients who do not agree to the protocol
  • non-Korean patients
  • pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Multiple myeloma

    Patients with suspicion of multiple myeloma and scheduled for CT

    Diagnostic Test: noncontrast-enhanced whole-body CT

Interventions

  • Diagnostic testnoncontrast-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.

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What researchers measure

Primary outcomes

  1. Contrast-to-noise ratio

    Contrast-to-noise ratio (CNR) of the vertebral body and paraspinal muscle obtained at L1 vertebra level

    Time frame: 3 months after the CT scan

Other outcomes

  1. Noise

    Noise at paraspinal muscle

    Time frame: 3 months after the CT scan

  2. Signal-to-noise ratio (SNR)

    Signal-to-noise ratio (SNR) at paraspinal muscle

    Time frame: 3 months after the CT scan

  3. Edge rising distance

    Edge rising distance at vertebral cortex

    Time frame: 3 months after the CT scan

  4. Subjective overall image quality

    Subjective overall image quality on four-point scale (1: worst, 4: excellent, representative value is average score)

    Time frame: 3 months after the CT scan

  5. Conspicuity of bone structure

    Conspicuity of bone structure on four-point scale (1: worst, 4: excellent, representative value is average score)

    Time frame: 3 months after the CT scan

  6. Conspicuity of soft tissue

    Conspicuity of soft tissue on four-point scale (1: worst, 4: excellent, representative value is average score)

    Time frame: 3 months after the CT scan

  7. Lesion detectability

    Myeloma lesion detection rate on conventional low-dose CT and ultra-low-dose CT by blinded reviewers

    Time frame: 3 months after the CT scan

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Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, 03080, South Korea
    • Hee-Dong Chae, MD · Contact · hdchae02@gmail.com · +82-2-2072-4209
    • Hee-Dong Chae, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2022 (actual). Primary completion is estimated for Dec 2022, 2 months after the start.

Of 175 non-industry observational studies under Multiple Myeloma, half reached primary completion within 70 months of starting (the median), counting those still running; a quarter within 33. This study's planned 2 months is below that.

Counting every sponsor, half of 238 studies reached it within 61 months; a quarter within 31 and three quarters within 126.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2022
First posted
Oct 13, 2022
StartActual
Oct 6, 2022
Primary completionEst.
Dec 31, 2022
CompletionEst.
Feb 28, 2023
Last update
Nov 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05577884
Responsible party
Hee-Dong Chae (Clinical Professor, Seoul National University Hospital) — Principal investigator
First posted
Oct 13, 2022
Start date
Oct 6, 2022
Primary completion
Dec 31, 2022 (estimated)
Completion
Feb 28, 2023 (estimated)
Last update
Nov 8, 2022

Study contacts

Hee-Dong Chae, MD
Contact
hdchae02@gmail.com
82-2-2072-4209
Jeong Hoon Park, BS
Contact
gns02066@naver.com
82-2-2072-3610
Hee-Dong Chae, MD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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