Imaging in MGUS, SMM and MM

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

18F-FDG PET CT and F18-NaF PET CT imaging results were compared in participants with MGUS, SMM, and MM. Lesions were considered positive if focal uptake corresponded to lesions identified on CT for NaF and negative if no uptake seen in lesions. Criteria to define FDG positivity included parameters published by Zamagni et al with focal abnormal uptake more intense than background.

Source null

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primary · POSTED

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.

Missing means the imaging test was not done. Unclear means it is indeterminate whether an imaging result is positive or negative.

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secondary · POSTED

The assay was performed according to the manufacture's protocol, and all samples were diluted 1:3. Cytokine values were calculated using a five-parameter standard curve with Bio-Plex Manager 6.1.

Serum was not available for three patients in the SMM group.

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secondary · POSTED

Microvessel density was estimated by determining the average number of cluster of differentiation 34 (CD34)-stained microvessels in 10 areas of maximal MVD counted at a high-power field (h.p.f. x 500 magnification). Large vessels and vessels in the periosteum on bone were excluded. Areas of staining with no discrete breaks were counted as a single vessel. The presence of a lumen was not required.

Three patients with MM did not undergo bone marrow biopsies and were not included in this analysis.

→

secondary · POSTED

Pharmacokinetic parameters Kep and Ktrans were measured by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).

Three patients with MM did not undergo bone marrow biopsies and were not included in this analysis.

→

secondary · POSTED

Pharmacokinetic parameter Kep was measured by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).

Serum was not available for three patients in the SMM group.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Comparison of Serum Angiogenic Markers Ang2 (Angiopoietin), G-CSF (Granulocyte-colony Stimulating Factor), Follistatin, HGF (Hepatocyte Growth Factor), FGF-1, Endothelin 1, and VEGF-A (Vascular Endothelial Growth Factor-A) Between MGUS and SMM/MM Groups

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-monoclonal-gammopathy-of-undetermined-significance
nct id: NCT01237054
qol key: qol-0002
source section id: NCT01237054-om-0002
source outcome index: 2
instrument: FACT
instrument basis: matched 'factor' in the study's own wording
scale title: Comparison of Serum Angiogenic Markers Ang2 (Angiopoietin), G-CSF (Granulocyte-colony Stimulating Factor), Follistatin, HGF (Hepatocyte Growth Factor), FGF-1, Endothelin 1, and VEGF-A (Vascular Endothelial Growth Factor-A) Between MGUS and SMM/MM Groups
measure definition: The assay was performed according to the manufacture's protocol, and all samples were diluted 1:3. Cytokine values were calculated using a five-parameter standard curve with Bio-Plex Manager 6.1.
time frame: 60 days
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Serum was not available for three patients in the SMM group.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-monoclonal-gammopathy-of-undetermined-significance
nct id: NCT01237054
trial label: Imaging in MGUS, SMM and MM
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 1
qol Count: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
outcome key
om-0000
source section id
NCT01237054-om-0000
source outcome index
0
endpoint
Count of Participants With Positive and Negative 18F-FDG PET CT and F18-NaF PET CT Imaging Results in Individuals With MGUS, SMM, and MM.
endpoint definition
18F-FDG PET CT and F18-NaF PET CT imaging results were compared in participants with MGUS, SMM, and MM. Lesions were considered positive if focal uptake corresponded to lesions identified on CT for NaF and negative if no uptake seen in lesions. Criteria to define FDG positivity included parameters published by Zamagni et al with focal abnormal uptake more intense than background.
time origin
60 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
outcome key
om-0001
source section id
NCT01237054-om-0001
source outcome index
1
endpoint
Count of Participants With Positive DCE-MRI Imaging Results
endpoint definition
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.
time origin
60 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Missing means the imaging test was not done. Unclear means it is indeterminate whether an imaging result is positive or negative.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
outcome key
om-0002
source section id
NCT01237054-om-0002
source outcome index
2
endpoint
Comparison of Serum Angiogenic Markers Ang2 (Angiopoietin), G-CSF (Granulocyte-colony Stimulating Factor), Follistatin, HGF (Hepatocyte Growth Factor), FGF-1, Endothelin 1, and VEGF-A (Vascular Endothelial Growth Factor-A) Between MGUS and SMM/MM Groups
endpoint definition
The assay was performed according to the manufacture's protocol, and all samples were diluted 1:3. Cytokine values were calculated using a five-parameter standard curve with Bio-Plex Manager 6.1.
time origin
60 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Serum was not available for three patients in the SMM group.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
outcome key
om-0003
source section id
NCT01237054-om-0003
source outcome index
3
endpoint
Comparison of Microvessel Density (MVD) Among Patients With MGUS, SMM, and MM
endpoint definition
Microvessel density was estimated by determining the average number of cluster of differentiation 34 (CD34)-stained microvessels in 10 areas of maximal MVD counted at a high-power field (h.p.f. x 500 magnification). Large vessels and vessels in the periosteum on bone were excluded. Areas of staining with no discrete breaks were counted as a single vessel. The presence of a lumen was not required.
time origin
60 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Three patients with MM did not undergo bone marrow biopsies and were not included in this analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
outcome key
om-0004
source section id
NCT01237054-om-0004
source outcome index
4
endpoint
Comparison of Reverse Contrast Transfer Rate (Kep) and Forward Contrast Transfer Rate (Ktrans) Among Patients With MGUS, SMM, and MM
endpoint definition
Pharmacokinetic parameters Kep and Ktrans were measured by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).
time origin
60 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Three patients with MM did not undergo bone marrow biopsies and were not included in this analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
outcome key
om-0005
source section id
NCT01237054-om-0005
source outcome index
5
endpoint
Comparison of Serum Angiogenic Marker Reverse Contrast Transfer Rate (Kep) Between MGUS and SMM/MM Groups
endpoint definition
Pharmacokinetic parameter Kep was measured by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).
time origin
60 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Serum was not available for three patients in the SMM group.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
outcome key
om-0000
arm key
OG000
arm label
MGUS (Monoclonal Gammopathy of Undetermined Significance)
regimen
MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01237054-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
outcome key
om-0000
arm key
OG001
arm label
SMM (Smoldering Multiple Myeloma)
regimen
Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01237054-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
outcome key
om-0000
arm key
OG002
arm label
MM (Multiple Myeloma)
regimen
Multiple myeloma is a plasma cell neoplasm.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01237054-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
outcome key
om-0001
arm key
OG000
arm label
MGUS (Monoclonal Gammopathy of Undetermined Significance)
regimen
MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01237054-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
outcome key
om-0001
arm key
OG001
arm label
SMM (Smoldering Multiple Myeloma)
regimen
Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01237054-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
outcome key
om-0001
arm key
OG002
arm label
MM (Multiple Myeloma)
regimen
Multiple myeloma is a plasma cell neoplasm.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01237054-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
outcome key
om-0002
arm key
OG000
arm label
MGUS (Monoclonal Gammopathy of Undetermined Significance)
regimen
MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01237054-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
outcome key
om-0002
arm key
OG001
arm label
SMM (Smoldering Multiple Myeloma)/MM (Multiple Myeloma)
regimen
Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder. Multiple myeloma is a plasma cell neoplasm.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01237054-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
outcome key
om-0003
arm key
OG000
arm label
MGUS (Monoclonal Gammopathy of Undetermined Significance)
regimen
MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01237054-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
outcome key
om-0003
arm key
OG001
arm label
SMM (Smoldering Multiple Myeloma)
regimen
Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01237054-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
outcome key
om-0003
arm key
OG002
arm label
MM (Multiple Myeloma)
regimen
Multiple myeloma is a plasma cell neoplasm.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01237054-om-0003#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
outcome key
om-0004
arm key
OG000
arm label
MGUS (Monoclonal Gammopathy of Undetermined Significance)
regimen
MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01237054-om-0004#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
harm key
EG000
source section id
NCT01237054-ae
event group key
EG000
event group label
Imaging in MGUS, SMM, and MM
serious affected
0
serious at risk
31
other affected
0
other at risk
31
frequency threshold
0
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT01237054
qol key
qol-0002
source section id
NCT01237054-om-0002
source outcome index
2
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Comparison of Serum Angiogenic Markers Ang2 (Angiopoietin), G-CSF (Granulocyte-colony Stimulating Factor), Follistatin, HGF (Hepatocyte Growth Factor), FGF-1, Endothelin 1, and VEGF-A (Vascular Endothelial Growth Factor-A) Between MGUS and SMM/MM Groups
measure definition
The assay was performed according to the manufacture's protocol, and all samples were diluted 1:3. Cytokine values were calculated using a five-parameter standard curve with Bio-Plex Manager 6.1.
time frame
60 days
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Serum was not available for three patients in the SMM group.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice