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

Expanded access is temporarily not available for this treatment.
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: May 23, 2012
Last verified: May 2012
  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: Expanded Access     What is Expanded Access?
Official Title: Pulmonary MR Angiography and Lower Extremity MR Venous Imaging Using a Single Dose of Gadofosveset (Ablavar)

Resource links provided by NLM:


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

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
Genders Eligible for Study:   Both
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
No Contacts or Locations Provided
  More Information

No publications provided

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: May 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
Pulmonary embolism
CT scan
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 April 21, 2014