TriangleNCT01237054 · OUTCOME
Count of Participants With Positive DCE-MRI Imaging Results
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 60 days
What was measured
DCE-MRI, an FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA). The criteria was presence of early and diffuse hyper-enhancement compared to the surrounding bone marrow. The pattern of marrow involvement on MRI was characterized as: (1) normal when there was no evidence of abnormal signal intensity; (2) focal, which consisted of localized areas of abnormal marrow; the lesions are darker than yellow marrow and slightly darker than or isointense to red marrow on T1-weights images; (3) diffuse, in which normal bone marrow signal intensity is completely absent, the intervertebral disks appear brighter than or isointense to the diseased marrow; and finally (4) heterogeneous that consists of innumerable small foci of disease on a background of intact marrow, with small dark lesions on T1-weighted images, which become bright on T2-weighted image.
Analysis population: Missing means the imaging test was not done. Unclear means it is indeterminate whether an imaging result is positive or negative.
Groups in this outcome
MGUS (Monoclonal Gammopathy of Undetermined Significance)
MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
SMM (Smoldering Multiple Myeloma)
Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
MM (Multiple Myeloma)
Multiple myeloma is a plasma cell neoplasm.
| Group | Source count |
|---|---|
| MGUS (Monoclonal Gammopathy of Undetermined Significance) | 10 |
| SMM (Smoldering Multiple Myeloma) | 10 |
| MM (Multiple Myeloma) | 10 |
Reported measurements
Positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MGUS (Monoclonal Gammopathy of Undetermined Significance) | 1 | Not reported | Not reported | Not reported | Not reported |
| SMM (Smoldering Multiple Myeloma) | 1 | Not reported | Not reported | Not reported | Not reported |
| MM (Multiple Myeloma) | 9 | Not reported | Not reported | Not reported | Not reported |
Negative
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MGUS (Monoclonal Gammopathy of Undetermined Significance) | 9 | Not reported | Not reported | Not reported | Not reported |
| SMM (Smoldering Multiple Myeloma) | 9 | Not reported | Not reported | Not reported | Not reported |
| MM (Multiple Myeloma) | 0 | Not reported | Not reported | Not reported | Not reported |
Missing
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MGUS (Monoclonal Gammopathy of Undetermined Significance) | 0 | Not reported | Not reported | Not reported | Not reported |
| SMM (Smoldering Multiple Myeloma) | 0 | Not reported | Not reported | Not reported | Not reported |
| MM (Multiple Myeloma) | 1 | Not reported | Not reported | Not reported | Not reported |
Unclear
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MGUS (Monoclonal Gammopathy of Undetermined Significance) | 0 | Not reported | Not reported | Not reported | Not reported |
| SMM (Smoldering Multiple Myeloma) | 0 | Not reported | Not reported | Not reported | Not reported |
| MM (Multiple Myeloma) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 9
- title
- Positive
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 0
- title
- Negative
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Missing
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Unclear
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 10
- units
- Participants
- description
- DCE-MRI, an FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA). The criteria was presence of early and diffuse hyper-enhancement compared to the surrounding bone marrow. The pattern of marrow involvement on MRI was characterized as: (1) normal when there was no evidence of abnormal signal intensity; (2) focal, which consisted of localized areas of abnormal marrow; the lesions are darker than yellow marrow and slightly darker than or isointense to red marrow on T1-weights images; (3) diffuse, in which normal bone marrow signal intensity is completely absent, the intervertebral disks appear brighter than or isointense to the diseased marrow; and finally (4) heterogeneous that consists of innumerable small foci of disease on a background of intact marrow, with small dark lesions on T1-weighted images, which become bright on T2-weighted image.
- groups
- description
- MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
- id
- OG000
- title
- MGUS (Monoclonal Gammopathy of Undetermined Significance)
- description
- Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
- id
- OG001
- title
- SMM (Smoldering Multiple Myeloma)
- description
- Multiple myeloma is a plasma cell neoplasm.
- id
- OG002
- title
- MM (Multiple Myeloma)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Missing means the imaging test was not done. Unclear means it is indeterminate whether an imaging result is positive or negative.
- reporting Status
- POSTED
- time Frame
- 60 days
- title
- Count of Participants With Positive DCE-MRI Imaging Results
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice