Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Lantheus Medical Imaging
Information provided by (Responsible Party):
Pamela Woodard, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01165892
First received: July 2, 2010
Last updated: December 8, 2014
Last verified: December 2014
History of Changes
  Purpose
The use of the contrast agent, Ablavar, will help with the diagnosis of pulmonary embolism in magnetic resonance imaging (MRI).

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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Imaging Outcome [ Time Frame: Upon imaging ] [ Designated as safety issue: No ]
    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)
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
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

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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
Health Authority: United States: Food and Drug Administration

Keywords provided by 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 September 27, 2016