WithdrawnPhase 4

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

Stopped: No patients enrolled as study did not move to enrollment stage

United States0Started 2016-12

Plain-language 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.

Who can participate

Age range

56 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patients required to undergo a clinically indicated CT examination Exclusion Criteria: * subject less than 56 yrs of age * pregnant women * Non English speaking * Abnormal Renal function * Allergy to Gadolinium

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vessel enhancement

Timeframe: Within 1 hour of contrast administration

Trial details

NCT IDNCT02163005

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12

View on ClinicalTrials.gov More Contrast Media Allergy trials