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

Myeloma Clinical Trial

— DECIMA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05353907
• Other study ID #: 274302
• Status: Not yet recruiting
• Start date: June 2022
• Est. completion date: December 2026

Study information

• Verified date: April 2022
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Ashik Amlani
• Phone: 02071885538
• Email: ashik.amlani[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell

Intervention

Radiation:
• Whole Body MRI
Once recruited, the participant will undergo a WB-MRI scan as part of their usual standard-of-care. As part of the research study, the participant will be consented to undertake an additional WB-DECT research scan at a time of their choosing (on the same day as the MRI scan, or on another day, if preferred)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)