TriangleNCT03951220 · OUTCOME
Primary Outcome 1: Quantifying Tumour Burden [Correlations With Myeloma Response Assessment and Diagnosis System (MY-RADS) Pattern of Disease]
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- grams per liter (g/L)
- Interval / dispersion
- Standard Deviation
- Time frame
- At baseline
What was measured
Primary Objective 1: To assess whether the novel MR protocol and exploratory bone biomarkers can improve quantification of tumour burden in patients with new or relapsed myeloma at baseline assessment, compared to paraprotein levels alone. Participants' baseline novel MR scan was analysed by an expert radiologist, and pattern of disease was qualitatively classified using the MY-RADS (Myeloma Response Assessment and Diagnosis System) imaging recommendations, described in Figure 2 by Messiou et. al. \[1\]. This particular section analysed whether standard clinical correlate of tumour burden (serum paraprotein) differed by radiological pattern of disease (e.g., normal, focal, diffuse). \[1\] Messiou, Christina, et al. "Guidelines for acquisition, interpretation, and reporting of whole-body MRI in myeloma: myeloma response assessment and diagnosis system (MY-RADS)." Radiology 291.1 (2019): 5-13.
Analysis population: Population is all participants who had a novel MR scan at baseline with: i) available MY-RADS pattern of disease assessment; ii) available baseline serum paraprotein.
Groups in this outcome
MY-RADS: Normal
MY-RADS disease pattern classification, as assessed by an expert MSK Radiologist, on baseline scans
MY-RADS: Focal
MY-RADS disease pattern classification, as assessed by an expert MSK Radiologist, on baseline scans
MY-RADS: Micronodular
MY-RADS disease pattern classification, as assessed by an expert MSK Radiologist, on baseline scans
MY-RADS: Not Determined
MY-RADS disease pattern classification, as assessed by an expert MSK Radiologist, on baseline scans
| Group | Source count |
|---|---|
| MY-RADS: Normal | 18 |
| MY-RADS: Focal | 6 |
| MY-RADS: Micronodular | 1 |
| MY-RADS: Not Determined | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MY-RADS: Normal | 13.1 | 9.4 | Not reported | Not reported | Not reported |
| MY-RADS: Focal | 11.7 | 7.8 | Not reported | Not reported | Not reported |
| MY-RADS: Micronodular | 5.4 | NA | Not reported | Not reported | Only one data point, hence standard deviation could not be calculated |
| MY-RADS: Not Determined | 17.2 | NA | Not reported | Not reported | Only one data point, hence standard deviation could not be calculated |
Source statistical analyses
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7343
- statistical Method
- ANOVA
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7343
- statistical Method
- ANOVA
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 9.4
- value
- 13.1
- group Id
- OG001
- spread
- 7.8
- value
- 11.7
- comment
- Only one data point, hence standard deviation could not be calculated
- group Id
- OG002
- spread
- NA
- value
- 5.4
- comment
- Only one data point, hence standard deviation could not be calculated
- group Id
- OG003
- spread
- NA
- value
- 17.2
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- units
- Participants
- description
- Primary Objective 1: To assess whether the novel MR protocol and exploratory bone biomarkers can improve quantification of tumour burden in patients with new or relapsed myeloma at baseline assessment, compared to paraprotein levels alone. Participants' baseline novel MR scan was analysed by an expert radiologist, and pattern of disease was qualitatively classified using the MY-RADS (Myeloma Response Assessment and Diagnosis System) imaging recommendations, described in Figure 2 by Messiou et. al. \[1\]. This particular section analysed whether standard clinical correlate of tumour burden (serum paraprotein) differed by radiological pattern of disease (e.g., normal, focal, diffuse). \[1\] Messiou, Christina, et al. "Guidelines for acquisition, interpretation, and reporting of whole-body MRI in myeloma: myeloma response assessment and diagnosis system (MY-RADS)." Radiology 291.1 (2019): 5-13.
- dispersion Type
- Standard Deviation
- groups
- description
- MY-RADS disease pattern classification, as assessed by an expert MSK Radiologist, on baseline scans
- id
- OG000
- title
- MY-RADS: Normal
- description
- MY-RADS disease pattern classification, as assessed by an expert MSK Radiologist, on baseline scans
- id
- OG001
- title
- MY-RADS: Focal
- description
- MY-RADS disease pattern classification, as assessed by an expert MSK Radiologist, on baseline scans
- id
- OG002
- title
- MY-RADS: Micronodular
- description
- MY-RADS disease pattern classification, as assessed by an expert MSK Radiologist, on baseline scans
- id
- OG003
- title
- MY-RADS: Not Determined
- param Type
- MEAN
- population Description
- Population is all participants who had a novel MR scan at baseline with: i) available MY-RADS pattern of disease assessment; ii) available baseline serum paraprotein.
- reporting Status
- POSTED
- time Frame
- At baseline
- title
- Primary Outcome 1: Quantifying Tumour Burden [Correlations With Myeloma Response Assessment and Diagnosis System (MY-RADS) Pattern of Disease]
- type
- PRIMARY
- unit Of Measure
- grams per liter (g/L)
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Preserved source evidence · Not medical advice