NCT00351754

Brief Summary

To compare the vascular enhancement of the two contrast agents in pulmonary Multi-detector CTA

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

June 30, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 13, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

January 7, 2008

Status Verified

January 1, 2008

First QC Date

June 30, 2006

Last Update Submit

January 3, 2008

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

  • Hounsfield Units (HU) measured at various levels of pulmonary arteries

Secondary Outcomes (1)

  • Presence of artifacts; global enhancement

Interventions

IsovueDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 yrs or older
  • With suspected PE
  • Referred for MDCTA of pulmonary arteries
  • Signed informed consent

You may not qualify if:

  • Pregnant and lactating females
  • History of hypersensitivity to iodinated contrast agents
  • Hyperthyroidism or pheochromocytoma
  • Severe CHF
  • Renal impairment
  • Weight greater than 300 lbs
  • Pacemaker
  • Swan Ganz catheter
  • Defibrillator or other intrathoracic metallic vascular device
  • Received an investigational compound within 30 days of being in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bracco Diagnostics, Inc.

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Iopamidol

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Triiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Steve Sireci, M.D.

    Bracco Diagnostics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 13, 2006

Study Start

July 1, 2006

Study Completion

November 1, 2006

Last Updated

January 7, 2008

Record last verified: 2008-01

Locations

US(1)