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

NCT05353907 | Not Yet Recruiting

• 1 other identifier: 274302
• Study Type: observational
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Qualitatively measure patient experience of WB-DECT compared to WB-MRI .

  Baseline (both scans acquired at the same time point)

• Intra & inter observer variability in subjective visual analysis and quantitative analysis of WB-DECT

  Baseline (both scans acquired at the same time point)

Interventions

Whole Body MRI RADIATION

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)

Also known as: Whole Body Dual Energy CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with suspected or newly diagnosed myeloma

You may qualify if:

• Adults with suspected or newly diagnosed myeloma

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Study Officials

• Vicky Goh

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashik Amlani

CONTACT

02071885538; ashik.amlani@gstt.nhs.uk

Nikeeta Gurung

CONTACT

nikeeta.gurung@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: April 29, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2022

Record last verified: 2022-04