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Updated: Aug 15, 2026
Registered Bioimaging of Nanomaterials for Diagnostic and Therapeutic Monitoring
Published on: December 10, 2010
[New super-paramagnetic iron particles for MRI. Phase II study of malignant liver tumors]
H E Daldrup1, P Reimer, E J Rummeny
1Institut für Klinische Radiologie, Universität Münster.
Abstract:
The clinical tolerability and diagnostic value of Resovist as a new superparamagnetic iron oxide contrast medium was studied in 30 patients with malignant focal liver lesions (28 metastases, 2 HCC) within a phase II multicenter study. Magnetic resonance imaging (MRI) was performed at 1.0 Tesla with T1-weighted FLASH- and T2-weighted spin echo sequences before and following intravenous injection of Resovist at three different dose groups (4, 8 and 16 mumol Fe/kg). Liver signal intensity was significantly reduced on post-contrast images, while malignant focal liver lesions showed no signal changes. Resovist improved tumor liver contrast and lesion-conspicuity, especially for lesions smaller than 1 cm. The dose of 8 mumol Fe/kg was sufficient to achieve diagnostic tumor-liver contrast. Compared to images directly after injection, the number of detected lesions did not improve until 70 min later. There were no significant changes in vital signs (heart rate, blood pressure) or laboratory values until 72 h post-injection.
Insights
Resovist, a new MRI contrast agent, effectively enhanced liver lesion detection in patients with malignant focal liver lesions. A dose of 8 mumol Fe/kg provided diagnostic tumor-liver contrast with good tolerability.
Area of Science:
- Radiology
- Oncology
- Medical Imaging
Background:
- Malignant focal liver lesions require accurate detection and characterization.
- Superparamagnetic iron oxide (SPIO) contrast agents offer potential for improved Magnetic Resonance Imaging (MRI).
Purpose of the Study:
- To evaluate the clinical tolerability and diagnostic value of Resovist, a novel SPIO contrast medium.
- To determine the optimal dose of Resovist for enhancing tumor-liver contrast in MRI.
Main Methods:
- A phase II multicenter study involving 30 patients with malignant focal liver lesions.
- MRI at 1.0 Tesla using T1-weighted FLASH and T2-weighted spin echo sequences.
- Intravenous injection of Resovist at doses of 4, 8, and 16 mumol Fe/kg, with pre- and post-contrast imaging.
Main Results:
- Resovist significantly reduced liver signal intensity post-contrast, improving tumor-liver contrast and lesion conspicuity, particularly for sub-centimeter lesions.
- A dose of 8 mumol Fe/kg achieved diagnostic contrast.
- No significant changes in vital signs or laboratory values were observed up to 72 hours post-injection, indicating good tolerability.
Conclusions:
- Resovist demonstrates favorable clinical tolerability and diagnostic value for detecting malignant focal liver lesions.
- The 8 mumol Fe/kg dose is recommended for achieving diagnostic tumor-liver contrast in MRI.
- Resovist enhances lesion conspicuity, aiding in the diagnosis of small liver metastases.
