NCT02234375

Brief Summary

The study will investigate patients with clinical suspicion for pulmonary embolism (PE) who have a contraindication to iodine based contrast. These patients normally get investigated with studies such as ultrasound and nuclear medicine studies but the fastest and preferred investigation is CT with contrast to look for filling defects in the pulmonary arteries. The investigators will assess whether gadolinium, which is currently used with MRI can be used with CT as an alternative effective contrast in diagnosis or exclusion of PE. A new type of CT scanner, a Dual Energy Scanner will be used to improve the visibility of Gadolinium contrast on CT.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

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

September 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
2.8 years until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

September 5, 2014

Last Update Submit

February 13, 2020

Conditions

Pulmonary Embolism

Keywords

Pulmonary embolismContrastComputed tomographyGadolinium

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of Pulmonary Embolism

    Ability of Gadolinium to diagnose pulmonary embolism on a dual energy CT scan

    24 hours

Study Arms (1)

Gadolinium enhancement

EXPERIMENTAL

Gadolinium enhancement will be performed using intravenous Dotarem\[recommended dose of 0.2 mL/kg (0.1 mmol Gd/kg )\]

Drug: Gadolinium

Interventions

GadoliniumDRUG

agents will be administered intravenously and a CT scan will be performed to evaluate contrast enhancement characteristics of the agents to assess their feasibility as an alternative to Iodine based contrast agents

Also known as: Dotarem
Gadolinium enhancement

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suspected of having a Pulmonary embolus
  • Allergy to Iodine based intravenous contrast

You may not qualify if:

  • Renal impairment
  • Less than 20 years of age
  • Non-English speaking
  • Pregnancy
  • Allergy to Gadolinium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Gadoliniumgadoterate meglumine

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lanthanoid Series ElementsMetals, Rare EarthElementsInorganic ChemicalsMetals
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiologist

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 9, 2014

Study Start

July 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

US(1)