Trial Outcomes & Findings for Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants (NCT NCT01431300)

NCT ID: NCT01431300

Last Updated: 2013-12-10

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 14 weeks
• Results posted on: 2013-12-10

Participant Flow

Participant milestones

Measure	0.01 mmol/kg of Gadofosveset Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition	0.02 mmol/kg of Gadofosveset Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition	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
Overall Study STARTED	11	10	10
Overall Study COMPLETED	10	10	10
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants

Baseline characteristics by cohort

Measure	0.01 mmol/kg n=11 Participants gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent	0.02 mmol/kg n=10 Participants gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent	0.03 mmol/kg n=10 Participants FDA-approved dose for lower extremity arterial imaging gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	31 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	22.2 years STANDARD_DEVIATION 5.3 • n=5 Participants	24.6 years STANDARD_DEVIATION 8.1 • n=7 Participants	24.1 years STANDARD_DEVIATION 7.5 • n=5 Participants	23.4 years STANDARD_DEVIATION 6.8 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	23 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	0.01 mmol/kg n=10 Participants gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent	0.02 mmol/kg n=10 Participants gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent	0.03 mmol/kg n=10 Participants FDA-approved dose for lower extremity arterial imaging gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
Imaging Quality Score	2.1 Units on a visualization score scale Interval 1.0 to 4.0	2.1 Units on a visualization score scale Interval 1.0 to 4.0	2.3 Units on a visualization score scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	0.01 mmol/kg n=10 Participants gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent	0.02 mmol/kg n=10 Participants gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent	0.03 mmol/kg n=10 Participants FDA-approved dose for lower extremity arterial imaging gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
Quantitative Analysis Noise Ratios signal to noise ratio	81 ratio Standard Deviation 17	119 ratio Standard Deviation 28	135 ratio Standard Deviation 25
Quantitative Analysis Noise Ratios contrast to noise ratio	37 ratio Standard Deviation 14	60 ratio Standard Deviation 28	80 ratio Standard Deviation 25

Adverse Events

0.01 mmol/kg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

0.02 mmol/kg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

0.03 mmol/kg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Charles Kim

Duke University Medical Center

Phone: 919-684-7284

Email: charles.kim@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place