Use of Gadolinium in CT Pulmonary Angiography
Primary Purpose
Pulmonary Embolism
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gadolinium
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Embolism focused on measuring Pulmonary embolism, Contrast, Computed tomography, Gadolinium
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gadolinium enhancement
Arm Description
Gadolinium enhancement will be performed using intravenous Dotarem[recommended dose of 0.2 mL/kg (0.1 mmol Gd/kg )]
Outcomes
Primary Outcome Measures
Diagnosis of Pulmonary Embolism
Ability of Gadolinium to diagnose pulmonary embolism on a dual energy CT scan
Secondary Outcome Measures
Full Information
NCT ID
NCT02234375
First Posted
September 5, 2014
Last Updated
February 13, 2020
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02234375
Brief Title
Use of Gadolinium in CT Pulmonary Angiography
Official Title
Efficacy of Gadolinium Contrast in CT Pulmonary Angiography in Patients With Allergy to Iodine
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Gadolinium attenuation in vitro inadequate
Study Start Date
July 2017 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
Pulmonary embolism, Contrast, Computed tomography, Gadolinium
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gadolinium enhancement
Arm Type
Experimental
Arm Description
Gadolinium enhancement will be performed using intravenous Dotarem[recommended dose of 0.2 mL/kg (0.1 mmol Gd/kg )]
Intervention Type
Drug
Intervention Name(s)
Gadolinium
Other Intervention Name(s)
Dotarem
Intervention Description
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
Primary Outcome Measure Information:
Title
Diagnosis of Pulmonary Embolism
Description
Ability of Gadolinium to diagnose pulmonary embolism on a dual energy CT scan
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
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Use of Gadolinium in CT Pulmonary Angiography
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