Fact CheckerSign in

NCT05353907Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 29 Apr 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
78 (estimated)
First submitted
4 Feb 2022
Start date
Jun 2022
Primary completion date
Dec 2025
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
NCT number
NCT05353907

What you commit to

  • Study type: Observational
  • Planned participants: 78
  • From Jun 2022 to the primary completion date, Dec 2025
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • No previous treatment for myeloma
  • No concurrent cancer elsewhere

Lab values

  • 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.

Other

  • No contraindications to CT or MRI scans

Who the study is looking for

  • Adults with suspected or newly diagnosed myeloma

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.