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NCT Number: NCT05353907

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Other names: Whole Body Dual Energy CT

Primary outcomes

  1. Sensitivity and specificity of WB-DECT

    Time frame: Baseline (both scans acquired at the same time point)

    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.

Secondary outcomes

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

    Time frame: Baseline (both scans acquired at the same time point)

    Pre and post scan questionnaire administered for both WB-MRI and WB-DECT. Thematic analysis will be used.

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

    Time frame: Baseline (both scans acquired at the same time point)

    Measured by Kappa statistic.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashik Amlani

CONTACT

[email protected]

02071885538

Nikeeta Gurung

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Acronym: DECIMA

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 29, 2022
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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