N/A
Completed N=31
Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT01431300 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: Imaging Quality Score — 2.1; 2.1; 2.3 Units on a visualization score scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Imaging Quality Score |
2.1; 2.1; 2.3 | — |
| SECONDARY Quantitative Analysis Noise Ratios |
81; 119; 135; 37; 60; 80 | <0.01 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01431300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.