Dual-Energy Computed Tomography for Improving Imaging Assessment of Multiple Myeloma (DECIMA)

Up to 30% of patients with newly diagnosed/suspected myeloma cannot undergo or do not tolerate whole body MRI (WB-MRI). A number of factors may be contributory. First, WB-MRI protocols can take in excess of 1 hour. Patients must remain still within a narrow bore scanner with multiple MRI coils that can be claustrophobic. Second, there is significant acoustic noise that can be heard despite the use of ear protection. Third, 80% of patients will experience bone pain or fracture at some point during their illness, affecting their comfort within the scanner. Fourth, patients also have higher anxiety. One review reported up to 30% of patients experienced considerable apprehension and up to 10% severe psychological distress when undergoing MRI. Finally, myeloma is predominantly an illness of the elderly and co-morbid conditions decrease patients' ability to tolerate a long scan. When WB-MRI cannot be performed, NICE recommend whole-body computed tomography (WB-CT), which the investigators know offers decreased diagnostic performance in terms of marrow assessment and focal lesion detection. The investigators believe that using a novel CT technique - dual-energy CT (DECT) - may offer better diagnostic performance over standard WB-CT in myeloma patients.

What the investigators seek to do in this study is to evaluate the sensitivity and specificity of DECT in a cohort of untreated patients; and compare the performance of DECT to simulated standard CT (data simulated from the DECT) and also to WB-MRI (reference standard alongside bone marrow biopsy results. The investigators will assess both subjective visual analysis of DECT images as well as CT quantitative values for the bone marrow.

Secondary objectives include assessment of patient experience across both imaging tests and assessment of intra & inter observer variability in subjective visual analysis

Study Overview

• Status: Not yet recruiting
• Conditions: Myeloma
• Intervention / Treatment: Radiation: Whole Body MRI

• Study Type: Observational
• Enrollment (Anticipated): 78

Contacts and Locations

• Study Contact: Name: Ashik Amlani; Phone Number: 02071885538; Email: ashik.amlani@gstt.nhs.uk
• Study Contact Backup: Name: Nikeeta Gurung; Email: nikeeta.gurung@gstt.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with suspected or newly diagnosed myeloma

Description

Inclusion Criteria:

• Adults with suspected or newly diagnosed myeloma

Exclusion Criteria:

• No previous treatment for myeloma
• No concurrent cancer elsewhere
• No contraindications to CT or MRI scans
• Routine, standard of care cut-off for minimum renal function (eGFR > 40 ml/min/1.73 m2) in order to receive IV gadolinium-based contrast media.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of WB-DECT	Sensitivity and specificity of whole body dual-energy CT (WB-DECT) to detect focal lesions and marrow infiltration compared to WB-MRI (gold standard) and WB-CT.	Baseline (both scans acquired at the same time point)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitatively measure patient experience of WB-DECT compared to WB-MRI .	Pre and post scan questionnaire administered for both WB-MRI and WB-DECT. Thematic analysis will be used.	Baseline (both scans acquired at the same time point)
Intra & inter observer variability in subjective visual analysis and quantitative analysis of WB-DECT	Measured by Kappa statistic.	Baseline (both scans acquired at the same time point)

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Vicky Goh, King's College London

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 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: 274302

Drug and device information, study documents

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