Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CG 10011 | Other Grant/Funding Number | Lantheus Medical Imaging |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lantheus Medical Imaging | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.03 mmol/kg | Active Comparator | FDA-approved dose for lower extremity arterial imaging |
|
| 0.02 mmol/kg | Experimental |
| |
| 0.01 mmol/kg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gadofosveset | Drug | Intravenous administration of the specified dosage of gadolinium contrast agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Charles Y Kim, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24045249 | Derived | Kim CY, Heye T, Bashir MR, Gebhard TA, Merkle EM. Gadofosveset-enhanced magnetic resonance angiography of the thoracic vasculature in the equilibrium phase: feasibility and impact of dose. J Comput Assist Tomogr. 2013 Sep-Oct;37(5):732-6. doi: 10.1097/RCT.0b013e318299dde9. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 0.01 mmol/kg of Gadofosveset | Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition |
| FG001 | 0.02 mmol/kg of Gadofosveset | Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition |
| FG002 | 0.03 mmol/kg of Gadofosveset | Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition. This is the FDA-approved dose for lower extremity arterial imaging |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 0.01 mmol/kg | gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent |
| BG001 | 0.02 mmol/kg | gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| Posted | Mean | Full Range | Units on a visualization score scale | 14 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.01 mmol/kg | gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Kim | Duke University Medical Center | 919-684-7284 | charles.kim@duke.edu |
Not provided
| ID | Term |
|---|---|
| C109932 | gadofosveset trisodium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 14 weeks |
| BG002 | 0.03 mmol/kg | FDA-approved dose for lower extremity arterial imaging gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | 0.03 mmol/kg | FDA-approved dose for lower extremity arterial imaging gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent |
|
|
| 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. | Posted | Mean | Standard Deviation | ratio | 14 weeks |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 0.02 mmol/kg | gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent | 0 | 10 | 0 | 10 |
| EG002 | 0.03 mmol/kg | FDA-approved dose for lower extremity arterial imaging gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent | 0 | 10 | 0 | 10 |
Not provided
Not provided
|
contrast-to-noise (CNR) ratios of the central veins in the 0.01 mmol/kg and 0.03mmol/kg dose groups were compared.
| t-test, 2 sided |
| <0.01 |
| Mean Difference (Final Values) |
| 43 |
| Standard Deviation |
| 19 |
| 95 |
| No |
| Superiority or Other |