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

Pulmonary Embolism Clinical Trial

Official title:

Pulmonary MR Angiography and Lower Extremity MR Venous Imaging Using a Single Dose of Gadofosveset (Ablavar)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165892
• Other study ID #: 10-0567
• Status: Completed
• Start date: July 2011
• Est. completion date: April 2013

Study information

• Verified date: March 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Lantheus Medical Imaging

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Imaging Outcome	Assessment of imaging parameters such as SNR, CNR	Upon imaging