Use of Gadolinium in CT Pulmonary Angiography

Phase 4

Withdrawn

• Conditions: Pulmonary Embolism
• Interventions: Drug: Gadolinium

• Registration Number: NCT02234375
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2014-09-05
• Study First Submitted QC: 2014-09-05
• Study First Posted: 2014-09-09
• Study Start: 2017-07
• Primary Completion: 2018-12
• Study Completion: 2019-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Diagnosis of Pulmonary Embolism	24 hours	Ability of Gadolinium to diagnose pulmonary embolism on a dual energy CT scan

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States