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

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ClinicalTrials.gov Identifier: NCT01165892
Recruitment Status : Completed
First Posted : July 20, 2010
Last Update Posted : December 10, 2014
Sponsor:
Collaborator:
Lantheus Medical Imaging
Information provided by (Responsible Party):
Pamela Woodard, MD, Washington University School of Medicine

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

Condition or disease Intervention/treatment
Pulmonary Embolism Drug: Gadofosveset Triodium

Detailed Description:

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


Study Design
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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmonary MR Angiography and Lower Extremity MR Venous Imaging Using a Single Dose of Gadofosveset (Ablavar)
Study Start Date : July 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

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Groups and Cohorts
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Intervention Details:
  • Drug: Gadofosveset Triodium
    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 Name: Ablavar

Outcome Measures
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Primary Outcome Measures :
  1. Imaging Outcome [ Time Frame: Upon imaging ]
    Assessment of imaging parameters such as SNR, CNR


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients 18 years or older with pulmonary embolism
Criteria

Inclusion Criteria:

  1. Patient that have pulmonary embolism.
  2. 18 yrs of age and older

Exclusion Criteria:

  1. allergy to gadolinium based contrast.
  2. allergy to iodated based contrast.
  3. renal insufficiency (GFR < 60 mL/min?1.73m2)
  4. pregnant or nursing
  5. contraindication to MRI
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01165892


Sponsors and Collaborators
Washington University School of Medicine
Lantheus Medical Imaging
Investigators
Principal Investigator: Pamela K Woodard, M.D. Washington University School of Medicine
More Information
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Responsible Party: Pamela Woodard, MD, Doctor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01165892     History of Changes
Other Study ID Numbers: 10-0567
First Posted: July 20, 2010    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014

Keywords provided by Pamela Woodard, MD, Washington University School of Medicine:
Pulmonary embolism
contrast agent

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases