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

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 Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Diagnostic test: noncontrast-enhanced whole-body CT

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Hee-Dong Chae, MD; Phone Number: 82-2-2072-4209; Email: hdchae02@gmail.com
• Study Contact Backup: Name: Jeong Hoon Park, BS; Phone Number: 82-2-2072-3610; Email: gns02066@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Hee-Dong Chae, MD; Phone Number: +82-2-2072-4209; Email: hdchae02@gmail.com
    • Principal Investigator: Hee-Dong Chae, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Multiple myeloma; Patients with suspicion of multiple myeloma and scheduled for CT

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noise	Noise at paraspinal muscle	3 months after the CT scan
Signal-to-noise ratio (SNR)	Signal-to-noise ratio (SNR) at paraspinal muscle	3 months after the CT scan
Edge rising distance	Edge rising distance at vertebral cortex	3 months after the CT scan
Subjective overall image quality	Subjective overall image quality on four-point scale (1: worst, 4: excellent, representative value is average score)	3 months after the CT scan
Conspicuity of bone structure	Conspicuity of bone structure on four-point scale (1: worst, 4: excellent, representative value is average score)	3 months after the CT scan
Conspicuity of soft tissue	Conspicuity of soft tissue on four-point scale (1: worst, 4: excellent, representative value is average score)	3 months after the CT scan
Lesion detectability	Myeloma lesion detection rate on conventional low-dose CT and ultra-low-dose CT by blinded reviewers	3 months after the CT scan

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hee-Dong Chae, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: SNUH-2021-4317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes