Use of Gadolinium in CT Pulmonary Angiography

Pulmonary Embolism Clinical Trial

Official title:

Efficacy of Gadolinium Contrast in CT Pulmonary Angiography in Patients With Allergy to Iodine

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02234375
• Other study ID #: 2012P002535b
• Status: Withdrawn
• Phase: Phase 4
• Start date: July 2017
• Est. completion date: December 2019

Study information

• Verified date: February 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of Pulmonary Embolism	Ability of Gadolinium to diagnose pulmonary embolism on a dual energy CT scan	24 hours