NCT01165892

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2010

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 20, 2010

Completed
12 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

July 2, 2010

Last Update Submit

March 12, 2020

Conditions

Pulmonary Embolism

Keywords

Pulmonary embolismcontrast agent

Outcome Measures

Primary Outcomes (1)

  • Imaging Outcome

    Assessment of imaging parameters such as SNR, CNR

    Upon imaging

Interventions

Gadofosveset TriodiumDRUG

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.

Also known as: Ablavar

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients 18 years or older with pulmonary embolism

You may qualify if:

  • Patient that have pulmonary embolism.
  • yrs of age and older

You may not qualify if:

  • allergy to gadolinium based contrast.
  • allergy to iodated based contrast.
  • renal insufficiency (GFR \< 60 mL/min?1.73m2)
  • pregnant or nursing
  • contraindication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Pamela K Woodard, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2010

First Posted

July 20, 2010

Study Start

July 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

March 17, 2020

Record last verified: 2020-03