Oral magnetic particles. Results from clinical phase II trials in 216 patients.
Oral magnetic particles (OMP) have been evaluated in a clinical phase II trial program comprising 216 patients in 7 European centers. Adult patients referred for MR imaging for various abdominal pathologies were examined. The patients received OMP at a concentration of 0.1 g/l (ultralow field) or 0.5 g/l (mid/high field) and OMP was diluted in water or in a more viscous liquid formulation. Depending on the area of interest, OMP was ingested in a volume of 300 to 800 ml. OMP was well tolerated with no serious adverse events and the patient acceptability was good. OMP had a good contrast effect on all applied pulse sequences. The viscous formulation of OMP was homogeneously distributed through the entire gastrointestinal tract without inducing disturbing susceptibility artifacts. The postcontrast diagnostic information was improved in 70% of the cases. Based on the encouraging results in phase II, OMP has been advanced to phase III clinical trials.
Oksendal
A N
AN
Nycomed AS, Oslo, Norway.
Bach-Gansmo
T
T
Jacobsen
T F
TF
Eide
H
H
Andrew
E
E
D000005:Abdomen / Q000473:pathology; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects; D003911:Dextrans; D004361:Drug Tolerance; D005060:Europe; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage / Q000009:adverse effects; D052203:Ferrosoferric Oxide; D006801:Humans; D007501:Iron / Q000008:administration & dosage / Q000009:adverse effects; D008279:Magnetic Resonance Imaging / Q000295:instrumentation / Q000379:methods; D008280:Magnetics / Q000009:adverse effects; D058185:Magnetite Nanoparticles; D008297:Male; D008875:Middle Aged; D010087:Oxides / Q000008:administration & dosage / Q000009:adverse effects
D003287:Contrast Media; D003911:Dextrans; D005290:Ferric Compounds; D058185:Magnetite Nanoparticles; D010087:Oxides; C001215:ferrite; D007501:Iron; C065507:ferumoxides; D052203:Ferrosoferric Oxide