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Phase I clinical evaluation of a new iron oxide MR contrast agent
Author(s) -
McLachlan Stuart J.,
Morris Marie R.,
Lucas Maria A.,
Fisco Ricardo A.,
Eakins Michael N.,
Fowler Dennis R.,
Scheetz R. Bradley,
Olukotun Adeoye Y.
Publication year - 1994
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/jmri.1880040313
Subject(s) - medicine , magnetic resonance imaging , placebo , lymph , adverse effect , mri contrast agent , radiology , relaxation (psychology) , contrast (vision) , clinical trial , nuclear medicine , pathology , alternative medicine , artificial intelligence , computer science
The safety and magnetic resonance (MR) imaging potential of BMS 180549, a new superparamagnetic iron oxide contrast agent, were evaluated in a phase I, open‐label, placebo‐controlled study involving 41 healthy subjects. No clinically significant postdose changes in physical examination findings, vital signs, or electrocardiogram results were reported for any of the subjects evaluated. No clinically significant changes in clinical laboratory values were noted by the investigators. Fourteen adverse events considered not serious and considered possibly or definitely related to the drug were reported, three of which required minor treatment. Relaxation time measurements in plasma samples showed a strong, dose‐dependent, and persistent decrease in T1 and T2 values. Significant changes in MR signal intensity of the blood pool and wellperfused organs (liver and spleen) were noted on both T1‐ and T2‐weighted images. Changes in signal intensity of cervical lymph nodes were also observed at the higher doses and late postdose imaging times.