A multicenter clinical trial of Gadolite Oral Suspension as a contrast agent for MRI

Daniel L. Rubin, Karen L. Falk, Malcolm J. Sperling, Michael Ross, Sanjay Saini, Barry Rothman, Frank Shellock, Elias Zerhouni, David Stark, Eric K. Outwater, Udo Schmiedl, Louis C. Kirby, Judith Chezmar, Terry Coates, Miles Chang, Jeffery M. Silverman, Neil Rofsky, Keith Burnett, Julie Engel, Stuart W. Young

Research output: Contribution to journalArticlepeer-review

18 Scopus citations

Abstract

The purpose of this study was to assess the effectiveness and safety of Gadolite Oral Suspension as a gastrointestinal (GI) contrast agent for MRI in a phase H and two phase HI multicenter clinical trials. Gadolite was administered to 306 patients with known or suspected abdominal and/or pelvic disease. MRI with T1 and T2-weighted sequences was performed before and after ingestion. Efficacy was evaluated by having two masked readers rate the certainty of their MR diagnosis (0 = uncertain, 1 = probable, 2 = definite) on randomly presented pre- and post-Gadolite Oral Suspension enhanced images. Principal investigators also evaluated the images and established the final diagnosis. Vital signs, clinical chemistries, and adverse events were documented. Blood and urine samples were analyzed for gadolinium content to determine whether Gadolite Oral Suspension was absorbed systemically. Certainty in MR diagnosis increased significantly (P < .001) for both blinded readers between pre and post-Gadolite images (.49-1.18 for reader 1; .461.53 for reader 2). Sensitivity, specificity, and accuracy also increased for both masked readers. No gadolinium was detected in blood or urine samples. There were no serious adverse events and no apparent drug-related trends in mean vital signs or laboratory values. Gadolite is a highly effective, safe, and well tolerated contrast agent for clinical use with MRI.

Original languageEnglish (US)
Pages (from-to)865-872
Number of pages8
JournalJournal of Magnetic Resonance Imaging
Volume7
Issue number5
DOIs
StatePublished - Sep 1 1997

Keywords

  • Abdomen
  • Contrast agent
  • Gadolite
  • Gastrointestinal
  • MR
  • Pelvis

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

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