Abstract | RATIONALE AND OBJECTIVES: In this phase III study, we evaluated the efficacy and safety of a negative contrast medium, ferristene (oral magnetic particles), among 277 patients undergoing magnetic resonance (MR) imaging of the abdomen. METHODS: Enhanced (800 ml ferristene) MR images were compared with unenhanced MR images in an intraindividual-patient control design. Adverse events were recorded. The examinations were performed on 1.5-T MR systems (T1- and T2-weighted sequences). RESULTS:
Ferristene increased the diagnostic information in 50.9% of the patients, particularly in those with abdominal masses, lymphoma, or pancreatic disease. Distribution of ferristene in the stomach, duodenum, jejunum, and ileum was complete or sufficient in 70.5-85% of the studies. In 64% of the patients, we were confident in the MR findings after the use of ferristene, and ferristene disclosed additional findings in 22% of the patients. The incidence of adverse events was 9.0%, but only 3.6% of all patients experienced ferristene-related adverse events (e.g., nausea, vomiting). Most events were mild or moderate in intensity. CONCLUSION:
Ferristene was well tolerated, and for 50% of the patients it added useful diagnostic information.
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Authors | T F Jacobsen, M Laniado, B E Van Beers, B Dupas, F P Boudghène, E Rummeny, T H Falke, P A Rinck, D MacVicar, B Lundby |
Journal | Academic radiology
(Acad Radiol)
Vol. 3
Issue 7
Pg. 571-80
(Jul 1996)
ISSN: 1076-6332 [Print] United States |
PMID | 8796719
(Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Multicenter Study)
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Chemical References |
- Contrast Media
- Ferric Compounds
- ferristene
- ferric oxide
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Topics |
- Administration, Oral
- Adolescent
- Adult
- Aged
- Contrast Media
(administration & dosage)
- Digestive System
(anatomy & histology)
- Digestive System Diseases
(pathology)
- Female
- Ferric Compounds
(administration & dosage)
- Humans
- Magnetic Resonance Imaging
(methods)
- Male
- Middle Aged
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