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
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Condition or disease | Intervention/treatment |
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Pulmonary Embolism | Drug: Gadofosveset Triodium |
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 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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Drug: Gadofosveset Triodium
- Imaging Outcome [ Time Frame: Upon imaging ]Assessment of imaging parameters such as SNR, CNR

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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
Principal Investigator: | Pamela K Woodard, M.D. | Washington University School of Medicine |
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 |