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Pulmonary MR Angiography and Lower Extremity MR Venous Imaging Using Gadofosveset (Ablavar)
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Purpose
| Condition | Intervention |
|---|---|
| Pulmonary Embolism | Drug: Gadofosveset Triodium |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pulmonary MR Angiography and Lower Extremity MR Venous Imaging Using a Single Dose of Gadofosveset (Ablavar) |
- Imaging Outcome [ Time Frame: Upon imaging ]Assessment of imaging parameters such as SNR, CNR
| Enrollment: | 15 |
| Study Start Date: | July 2011 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
-
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
Eligibility| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01165892
| Principal Investigator: | Pamela K Woodard, M.D. | Washington University School of Medicine |
More Information
| Responsible Party: | Pamela Woodard, MD, Doctor, Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01165892 History of Changes |
| Other Study ID Numbers: |
10-0567 |
| Study First Received: | July 2, 2010 |
| Last Updated: | December 8, 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 |
ClinicalTrials.gov processed this record on July 24, 2017