Use of Gadolinium in CT Pulmonary Angiography | NCT02234375

Studies
Use of Gadolinium in CT Pulmonary Angiography

NCT02234375

Sponsor

Massachusetts General Hospital

Status

Withdrawn

Last Update Posted

Feb 17, 2020Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Pulmonary Embolism

Interventions

Gadolinium

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Gadolinium attenuation in vitro inadequate

Expanded Access Info

Start Date

Jul 2017Estimated

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Sep 5, 2014

First Submission Date that Met QC Criteria

Sep 5, 2014

First Posted Date

Sep 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2020

Last Update Posted Date

Feb 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gadolinium enhancement	Experimental	Gadolinium enhancement will be performed using intravenous Dotarem[recommended dose of 0.2 mL/kg (0.1 mmol Gd/kg )]	Drug: Gadolinium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gadolinium	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnosis of Pulmonary Embolism	Ability of Gadolinium to diagnose pulmonary embolism on a dual energy CT scan	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

Condition Browse Module

MeSH Terms

ID	Term
D011655	Pulmonary Embolism

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism
D016769	Embolism and Thrombosis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005682	Gadolinium
C072417	gadoterate meglumine

Ancestor Terms

ID	Term
D028581	Lanthanoid Series Elements
D008674	Metals, Rare Earth
D004602	Elements
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided