Use of Gadolinium in CT Pulmonary Angiography

NCT ID: NCT02234375

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Contrast enhancement with Gadolinium will be evaluated to assess its efficacy for diagnosis and exclusion of pulmonary embolism in a patient who previously would not have been investigated with CTPA due to an underlying allergy to contrast or other contraindication. If this proves beneficial, it will allow such patients to be investigated successfully with CTPA

Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Gadolinium enhancement

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

Group Type EXPERIMENTAL

Gadolinium

Intervention Type DRUG

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

Interventions

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Gadolinium

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

Intervention Type DRUG

Other Intervention Names

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Dotarem

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Renal impairment
* Less than 20 years of age
* Non-English speaking
* Pregnancy
* Allergy to Gadolinium
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Amita Sharma, MD

Radiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2012P002535b

Identifier Type: -

Identifier Source: org_study_id

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