Healthy
Conditions
Keywords
central veins, thorax, superior vena cava, Central vein imaging
Brief summary
The purpose of this study is to assess the image quality of Ablavar-enhanced MR angiography of the central veins of the chest, and to determine whether dose reduction can be performed while maintaining image quality. This will be a prospective randomized study, in which healthy volunteers will be recruited to undergo a central veins magnetic resonance angiogram (MRA). They will receive either the FDA-approved dose or a lower dose of Ablavar. Quantitative and qualitative analysis will be performed on the images.
Interventions
DRUGgadofosveset
Intravenous administration of the specified dosage of gadolinium contrast agent
Sponsors
Lantheus Medical Imaging
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy male or female subjects between 18-45 years of age
Exclusion criteria
* Pregnant and lactating females * known renal impairment * allergy to gadolinium-based contrast * metallic implanted devices * claustrophobia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Imaging Quality Score | 14 weeks | Two radiologists assessed imaging quality of each central venous segment for each patient, in order to compare imaging quality between each of the three doses administered. The visualization score for each venous segments was as follows: 1. poor / nondiagnostic 2. adequate 3. good 4. excellent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Analysis Noise Ratios | 14 weeks | Signal-to-noise and contrast-to-noise ratios were calculated for each central venous segment, to determine the magnitude of difference in each of the three administered doses. The ratio's were calculated as follows: Signal-to-noise ratio: signal intensity of vessel segment / standard deviation of signal intensity of the background. Contrast-to-noise ratio = (signal intensity of vessel segment minus signal intensity of adjacent muscle) / standard deviation of signal intensity of the background. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.01 mmol/kg gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent | 11 |
| 0.02 mmol/kg gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent | 10 |
| 0.03 mmol/kg FDA-approved dose for lower extremity arterial imaging
gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent | 10 |
| Total | 31 |
Baseline characteristics
| Characteristic | 0.01 mmol/kg | 0.02 mmol/kg | 0.03 mmol/kg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 10 Participants | 10 Participants | 31 Participants |
| Age Continuous | 22.2 years STANDARD_DEVIATION 5.3 | 24.6 years STANDARD_DEVIATION 8.1 | 24.1 years STANDARD_DEVIATION 7.5 | 23.4 years STANDARD_DEVIATION 6.8 |
| Sex: Female, Male Female | 1 Participants | 6 Participants | 1 Participants | 8 Participants |
| Sex: Female, Male Male | 10 Participants | 4 Participants | 9 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Imaging Quality Score
Two radiologists assessed imaging quality of each central venous segment for each patient, in order to compare imaging quality between each of the three doses administered. The visualization score for each venous segments was as follows: 1. poor / nondiagnostic 2. adequate 3. good 4. excellent
Time frame: 14 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 0.01 mmol/kg | Imaging Quality Score | 2.1 Units on a visualization score scale |
| 0.02 mmol/kg | Imaging Quality Score | 2.1 Units on a visualization score scale |
| 0.03 mmol/kg | Imaging Quality Score | 2.3 Units on a visualization score scale |
Secondary
Quantitative Analysis Noise Ratios
Signal-to-noise and contrast-to-noise ratios were calculated for each central venous segment, to determine the magnitude of difference in each of the three administered doses. The ratio's were calculated as follows: Signal-to-noise ratio: signal intensity of vessel segment / standard deviation of signal intensity of the background. Contrast-to-noise ratio = (signal intensity of vessel segment minus signal intensity of adjacent muscle) / standard deviation of signal intensity of the background.
Time frame: 14 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.01 mmol/kg | Quantitative Analysis Noise Ratios | signal to noise ratio | 81 ratio | Standard Deviation 17 |
| 0.01 mmol/kg | Quantitative Analysis Noise Ratios | contrast to noise ratio | 37 ratio | Standard Deviation 14 |
| 0.02 mmol/kg | Quantitative Analysis Noise Ratios | signal to noise ratio | 119 ratio | Standard Deviation 28 |
| 0.02 mmol/kg | Quantitative Analysis Noise Ratios | contrast to noise ratio | 60 ratio | Standard Deviation 28 |
| 0.03 mmol/kg | Quantitative Analysis Noise Ratios | signal to noise ratio | 135 ratio | Standard Deviation 25 |
| 0.03 mmol/kg | Quantitative Analysis Noise Ratios | contrast to noise ratio | 80 ratio | Standard Deviation 25 |
Comparison: signal-to-noise (SNR) ratios of the central veins in the 0.01 mmol/kg and 0.03mmol/kg dose groups were compared.p-value: <0.01t-test, 2 sided
Comparison: contrast-to-noise (CNR) ratios of the central veins in the 0.01 mmol/kg and 0.03mmol/kg dose groups were compared.p-value: <0.01t-test, 2 sided