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A multisite phase III study of the safety and efficacy of a new manganese chloride‐based gastrointestinal contrast agent for MRI of the abdomen and pelvis
Author(s) -
Small William C.,
DeSimoneMacchi Debra,
Parker John R.,
Sukerkar Arun,
Hahn Peter F.,
Rubin Daniel L.,
Zelch James V.,
Kuhlman Janet E.,
Outwater Eric K.,
Weinreb Jeffrey C.,
Brown Jeffrey J.,
de Lange Eduard E.,
Woodward Paula J.,
Arildsen Ronald,
Foster Gregory S.,
Runge Val M.,
Aisen Alex M.,
Muroff Lawrence R.,
Thoeni Ruedi F.,
Parisky Yuri R.,
Tanenbaum Lawrence N.,
Totterman Saara,
Herfkens Robert J.,
Knudsen John,
Laster, Jr. Robert E.,
Duerinckx Andre,
Stillman Arthur E.,
Spritzer Charles E.,
Saini Sanjay,
Rofsky Neil M.,
Bernardino Michael E.
Publication year - 1999
Publication title -
journal of magnetic resonance imaging
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.563
H-Index - 160
eISSN - 1522-2586
pISSN - 1053-1807
DOI - 10.1002/(sici)1522-2586(199907)10:1<15::aid-jmri3>3.0.co;2-x
Subject(s) - medicine , abdomen , pelvis , perforation , magnetic resonance imaging , radiology , clinical trial , adverse effect , placebo , iodinated contrast , pathology , computed tomography , materials science , metallurgy , punching , alternative medicine
The purpose of this study was to evaluate the safety and efficacy of a manganese chloride‐based oral magnetic resonance (MR) contrast agent during a Phase III multisite clinical trial. Two hundred seventeen patients were enrolled who were already scheduled for MRI of the abdomen and/or pelvis. In this group of patients, it was postulated that the use of an oral agent would better allow discrimination of pathology from bowel. Patients with known gastrointestinal pathology including peptic ulcer disease, inflammatory bowel disease, obstruction, or perforation were excluded to minimize confounding variables that could affect the safety assessment. Of these 217 patients, 18 received up to 900 mL of placebo, and 199 patients were given up to 900 mL of a manganese chloride‐based oral contrast agent, LumenHance® (Bracco Diagnostics, Inc.). Safety was determined by comparing pre‐ and post‐dose physical examinations, vital signs, and laboratory examinations and by documenting adverse events. Efficacy was assessed by unblinded site investigators and two blinded reviewers who compared pre‐ and post‐dose T1‐ and T2‐weighted MRI scans of the abdomen and/or pelvis. In 111 (57%) of the 195 cases evaluated for efficacy by site investigators (unblinded readers), MRI after LumenHance provided additional diagnostic information. Increased information was found by two blinded readers in 52% and 51% of patients, respectively. In 44/195 cases (23%) unblinded readers felt the additional information would have changed patient diagnosis and in 50 patients (26%), it would have changed management and/or therapy. Potential changes in patient diagnosis or management/therapy were seen by the two blinded readers in 8–20% of patients. No clinically significant post‐dose laboratory changes were seen. Forty‐eight patients (24%) receiving LumenHance and four patients (22%) receiving placebo experienced one or more adverse events. Gastrointestinal tract side effects were most common, seen in 29 (15%) of LumenHance patients and in 3 (17%) of the placebo patients. LumenHance is a safe and efficacious oral gastrointestinal contrast agent for MRI of the abdomen and pelvis.J. Magn. Reson. Imaging 1999;10:15–24. © 1999 Wiley‐Liss, Inc.