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Trial record 4 of 9 for:    Recruiting, Not yet recruiting, Available Studies | Allergy CT

Use of Gadolinium in CT Pulmonary Angiography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02234375
Recruitment Status : Not yet recruiting
First Posted : September 9, 2014
Last Update Posted : September 28, 2016
Information provided by (Responsible Party):
Amita Sharma, MD, 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.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Drug: Gadolinium Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Efficacy of Gadolinium Contrast in CT Pulmonary Angiography in Patients With Allergy to Iodine
Study Start Date : July 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Gadolinium enhancement
Gadolinium enhancement will be performed using intravenous Dotarem[recommended dose of 0.2 mL/kg (0.1 mmol Gd/kg )]
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
Other Name: Dotarem

Primary Outcome Measures :
  1. Diagnosis of Pulmonary Embolism [ Time Frame: 24 hours ]
    Ability of Gadolinium to diagnose pulmonary embolism on a dual energy CT scan

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02234375

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United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Amita Sharma, MD    617-724-4254   
Principal Investigator: Amita Sharma, MD         
Sponsors and Collaborators
Massachusetts General Hospital

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Responsible Party: Amita Sharma, MD, Radiologist, Massachusetts General Hospital Identifier: NCT02234375     History of Changes
Other Study ID Numbers: 2012P002535b
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Keywords provided by Amita Sharma, MD, Massachusetts General Hospital:
Pulmonary embolism
Computed tomography
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases