MyelomaDECIMANCT05353907
Dual-Energy Computed Tomography for Improving Imaging Assessment of Multiple Myeloma
An observational study of Myeloma, run by Guy's and St Thomas' NHS Foundation Trust.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma
- What is being tested?
- Whole Body MRI
- Type of treatment
- Surgery or procedure
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with suspected or newly diagnosed myeloma
Who may be able to join
- Adults with suspected or newly diagnosed myeloma
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Nikeeta Gurung contact
About this study
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
- Being tested
- Whole Body MRI
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body MRIRadiation
Also called Whole Body Dual Energy CT
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (both scans acquired at the same time point)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline (both scans acquired at the same time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study startJun 2022 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomaStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vicky Goh, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353907
- Sponsor's protocol ID
- 274302
- Acronym
- DECIMA
- Status last verified
- Apr 2022
- First submitted
- 4 Feb 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-Energy Computed Tomography for Improving Imaging Assessment of Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05353907
- Acronym / sponsor ID
- DECIMA / 274302
- Conditions
- Myeloma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with suspected or newly diagnosed myeloma
Key inclusion criteria (1 listed)
- Adults with suspected or newly diagnosed myeloma
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Body MRIAlso: Whole Body Dual Energy CTOnce 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) | Radiation | – |
Primary outcome
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.
2 secondary outcomes
Qualitatively measure patient experience of WB-DECT compared to WB-MRI .
Time frame: Baseline (both scans acquired at the same time point)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikeeta Gurung contact
Vicky Goh principal investigator
King's College London
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloma, run by Guy's and St Thomas' NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashik Amlani (02071885538, ashik.amlani@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of WB-DECT (time frame: Baseline (both scans acquired at the same time point)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.