Pulmonary MR Angiography and Lower Extremity MR Venous Imaging Using Gadofosveset (Ablavar)

The use of the contrast agent, Ablavar, will help with the diagnosis of pulmonary embolism in magnetic resonance imaging (MRI).

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Specific Aim 1: To assess first-pass SNR and CNR of pulmonary MR angiography performed with 0.03 mmol/Kg of intravenous gadofosveset trisodium.

Hypothesis: Use of 0.03 mmol/Kg of gadofosveset trisodium in gradient recalled echo pulmonary MR angiography will provide a pulmonary artery SNR and CNR equal to or better than the SNR and CNR obtained using the same MR technique with 0.2 mmol/Kg of a conventional contrast agent (gadopentetate dimeglumine) and equal to or better than 0.1 mmol/Kg of intravenous gadobenate dimeglumine. Data will be compared to SNR and CNR of pulmonary MR angiogram images obtained at Washington University as part of the PIOPED III study.

Specific Aim 2: To assess SNR and CNR of breath-hold pulmonary MR imaging obtained immediately after the original first-pass breath-hold pulmonary MR angiography.

Hypothesis: SNR and CNR of pulmonary MR angiography performed immediately after first-pass breath-hold pulmonary MR angiography will be at least equal to the SNR and CNR obtained using the same MR technique with 0.2 mmol/Kg of a conventional contrast agent (gadopentetate dimeglumine) and at least equal to 0.1 mmol/Kg of intravenous gadobenate dimeglumine.

Specific Aim 3: To assess SNR and CNR of lower extremity MR venogram (MRV) performed immediately after the two pulmonary MR angiograms, described above.

Hypothesis: SNR and CNR of passive lower extremity MRV performed after pulmonary MR angiography will be equal to or better than the SNR and CNR obtained using the same passive MRV technique with 0.2 mmol/Kg of a conventional contrast agent or 0.1 mmol/Kg of gadobenate dimeglumine. Again, data will be compared to SNR and CNR of lower extremity

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient that have pulmonary embolism.
18 yrs of age and older

Exclusion criteria

allergy to gadolinium based contrast.
allergy to iodated based contrast.
renal insufficiency (GFR < 60 mL/min?1.73m2)
pregnant or nursing
contraindication to MRI

Treatment and study plan

Gadofosveset Triodium

Drug

Use of 0.03 mmol/Kg of gadofosveset trisodium (Ablavar)once with intravascular half life of up to 1 hr and optimal arterial imaging out to 20-30 minutes.

Other names: Ablavar

Primary outcomes

Imaging Outcome

Time frame: Upon imaging

Assessment of imaging parameters such as SNR, CNR

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

Lantheus Medical Imaging

Registry information

Official study title

Pulmonary MR Angiography and Lower Extremity MR Venous Imaging Using a Single Dose of Gadofosveset (Ablavar)

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jul 20, 2010
Registry last updated: Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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