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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05577884
• Other study ID #: SNUH-2021-4317
• Status: Recruiting
• Start date: October 6, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: November 2022
• Source: Seoul National University Hospital
• Contact: Hee-Dong Chae, MD
• Phone: 82-2-2072-4209
• Email: hdchae02[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 28, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Noise	Noise at paraspinal muscle	3 months after the CT scan
Other	Signal-to-noise ratio (SNR)	Signal-to-noise ratio (SNR) at paraspinal muscle	3 months after the CT scan
Other	Edge rising distance	Edge rising distance at vertebral cortex	3 months after the CT scan
Other	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
Other	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
Other	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
Other	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
Primary	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