Treatment Trials

4 Clinical Trials for Various Conditions

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COMPLETED
Assessment of Immediate Adverse Reactions From Dotarem in Children Under 2 Years of Age
Description

Our primary outcome is to assess the safety of Dotarem in children \<2 years old up to 24 hours after Dotarem injection. Patients will be monitored for any adverse events that occur for 2 hours following the completion of the MRI exam. The type of event, time of onset, duration of symptoms, intensity of the reaction (mild, moderate, severe), causality (not related, probably related, related, definitely related, unclassifiable), and subsequent outcome (required treatment, favorable outcome, recovery with sequela, or death) will be documented. Parents will be given instruction sheets on who and when to call should any adverse event occur after discharge. Parents will be called by the radiology department the next day to identify any adverse events that occurred during the first 24 hours after discharge from the hospital. Our secondary outcome is to assess image quality of the exam. The pre-contrast images will be compared to the combined pre- and post-contrast images following administration of Dotarem by radiologists who are blinded to the patients' clinical information to assess for improvement of image quality and delineation of structures with contrast.

WITHDRAWN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

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.

COMPLETED
Reactions to Contrast Media (CM) Administered at the Time of the Endoscopic Retrograde Cholangiopancreatography (ERCP)
Description

The aim of this study is to prospectively document the incidence of CM adverse reactions at the time of ERCP and to determine whether various perceived risk factors are predictive of adverse reaction. Adverse reactions to iodine containing contrast media (CM) have been described after endoscopic retrograde cholangiopancreaticography (ERCP) but have been difficult to study due to their extremely low incidence. Adverse reactions can be classified by severity (mild, moderate or severe) or underlying mechanism (idiosyncratic versus nonidiosyncratic). Nonidiosyncratic reactions are related to the dose and osmolality of the CM; these are not observed during ERCP due to the relative small amount of systemic absorption of CM. Idiosyncratic reactions on the other hand are not dose-dependent and generally occur shortly after administration of CM. Premedication with corticosteroids, H1/H2 -blockers and the use of low osmolality CM is beneficial in preventing nonidiosyncratic reactions during intravascular administration. However their role in during ERCP is unclear as CM is not injected into the intravascular space. Currently there are no formal recommendations and clinical practice varies considerably. The general purpose of this study is to determine the incidence of CM reactions during ERCP and to determine whether various risk factors are predictive of idiosyncratic reactions. Based on these results, we hope to develop guidelines for the use of prophylaxis to prevent CM reactions in ERCP.

COMPLETED
CT Scan Using IV Contrast Alone for Pediatric Appendicitis
Description

Computed tomography (CT) scan using intravenous contrast (CT IV) as the sole type of contrast material, was studied as one method of evaluating children with suspected appendicitis. We felt that this technique could provide physicians with a faster and better-tolerated alternative to CT imaging which involves patients drinking oral contrast or needing rectal contrast administered. SPECIFIC AIMS 1. To test an imaging protocol using CT IV for the evaluation of suspected appendicitis in children in the setting of a pediatric emergency department (ED). 2. To determine test performance characteristics (specificity, sensitivity and diagnostic accuracy) of CT IV in detecting appendicitis in children.