A Feasibility Study to Assess the Use of Gadolinium in Computed Tomography

NCT02163005 | Withdrawn Phase 4

• 1 other identifier: 2012P002535a
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with an allergy to iodine based intravenous contrast cannot undergo a CT scan with contrast, unless they are premedicated. Premedication can result in a delay in diagnosis, that can be significant with acute conditions such as Pulmonary embolism. The investigators are evaluating the use of Gadolinium as an alternative contrast agent in CT. Gadolinium has been used extensively in MRI exams but the dose that is used is not sufficient to provide good enhancement on CT. Dual Energy CT is a new technology that has better sensitivity to lower doses of intravenous contrast and the investigators aim to study its effectiveness in improving the enhancement with Gadolinium. The investigators will compare enhancement of Iodine with enhancement of Gadolinium during Dual Energy CT, to assess the possibility that Gadolinium could be used as an alternative for patients who are suspected of having Pulmonary embolism. They will recruit up to 50 patients who are having a routine Chest CT during treatment for a malignancy and administer Gadolinium contrast and Iodine contrast during a chest CT exam. The enhancement with the two agents can be compared.

Conditions

Contrast Media Allergy

Keywords

GDL contrast agent

Outcome Measures

Primary Outcomes (1)

• Vessel enhancement

  Following injection of Gadolinium based intravenous contrast, a CT scan will be performed and the level of enhancement of vessels by Gadolinium based contrast will be measured

  Within 1 hour of contrast administration

Study Arms (1)

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

Gadolinium DRUG

-agent will be administered intravenously and a CT scan will be performed to evaluate contrast enhancement characteristics of the agent to assess its feasibility as an alternative to Iodine based contrast agents.

Also known as: Dotarem

Gadolinium enhancement

Eligibility Criteria

• Age: 56 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients required to undergo a clinically indicated CT examination

You may not qualify if:

• subject less than 56 yrs of age
• pregnant women
• Non English speaking
• Abnormal Renal function
• Allergy to Gadolinium

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Gadolinium; gadoterate meglumine

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals

Study Officials

• Amita Sharma, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiologist

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 13, 2014
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 4, 2021

Record last verified: 2021-04

Locations

US (1)