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Oral magnetic particles (ferristene) as a contrast medium in abdominal magnetic resonance imaging
T F Jacobsen1, M Laniado, B E Van Beers
1Nycomed Imaging AS, Oslo, Norway.
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.
Insights
Ferristene, an oral magnetic particle contrast agent, improved diagnostic information in half of patients undergoing abdominal MR imaging. This negative contrast medium was well-tolerated with a low incidence of mild adverse events.
Area of Science:
- Radiology
- Gastroenterology
- Medical Imaging
Background:
- Magnetic resonance (MR) imaging is a key diagnostic tool for abdominal conditions.
- Negative contrast agents can enhance MR imaging visualization of the gastrointestinal tract.
- Ferristene is an oral magnetic particle suspension designed for gastrointestinal MR imaging.
Purpose of the Study:
- To evaluate the efficacy and safety of ferristene as a negative contrast medium in abdominal MR imaging.
- To assess the diagnostic yield of ferristene in a phase III clinical trial.
- To compare enhanced MR images with unenhanced MR images for abdominal pathology.
Main Methods:
- A phase III, intraindividual-patient controlled study involving 277 patients.
- Administration of 800 ml ferristene as an oral negative contrast agent.
- Comparison of enhanced and unenhanced MR images acquired on 1.5-T MR systems using T1- and T2-weighted sequences.
Main Results:
- Ferristene provided increased diagnostic information in 50.9% of patients, particularly for abdominal masses, lymphoma, and pancreatic disease.
- Sufficient distribution of ferristene was achieved in 70.5-85% of the gastrointestinal tract.
- Confidence in MR findings increased in 64% of patients, with additional findings disclosed in 22%.
Conclusions:
- Ferristene is a well-tolerated negative contrast agent for abdominal MR imaging.
- The agent added useful diagnostic information in approximately 50% of patients.
- Adverse events were generally mild to moderate, with a 3.6% incidence of ferristene-related events.
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