Phase III multicenter trial of high-dose gadoteridol in MR evaluation of brain metastases
- Univ. of Iowa College of Medicine, Iowa City, IA (United States)
- Univ. of Kentucky Medical Center, Lexington, KY (United States)
- Univ. of Pennsylvania, Philadelphia, PA (United States)
- Baylor Univ. Medical Center, Dallas, TX (United States)
- Univ. of Washington, Seattle, WA (United States)
- Albany Medical Center, NY (United States)
To assess the efficacy and safety profile of high-dose (0.3 mmol/kg cumulative dose) gadoteridol in patients with suspected central nervous system metastatic disease. We studied 67 patients using an incremental-dose technique. Patient monitoring included a medical history, physical examination, vital signs, and extensive laboratory tests within 24 hours before and after the MR examination. Precontrast T1- and T2-weighted spin-echo studies were performed, followed by intravenous injection of 0.1 mmol/kg of gadoteridol. T1-weighted images were acquired immediately after and at 10 and 20 minutes after injection. At 30 minutes an additional 0.2 mmol/kg of gadoteridol was administered, and T1-weighted images were acquired. Cases demonstrating abnormal MR findings were assessed for efficacy by unblinded and blinded reviewers and were analyzed quantitatively. Three adverse effects in two patients were considered to be related to gadoteridol administration. No adverse effects were serious; all self-resolved. Forty-nine cases showed abnormal MR findings and were included in the efficacy analysis. A significantly greater number of lesions was seen on the high-dose as opposed to the standard-dose images. Blinded and unblinded readers identified 5 and 8 patients, respectively, with solitary lesions on standard-dose examination and multiple lesions on high-dose examination. Two patients who had normal standard-dose findings had lesions identified on high-dose studies. Quantitative analysis of 133 lesions in 45 patients demonstrated significant increased in lesion signal intensity on high-dose studies when compared with standard-dose studies. Gadoteridol can be safely administered up to a cumulative dose of 0.3 mmol/kg. High-dose contrast studies provide improved lesion detectability and additional diagnostic information over studies performed in the same patients with a 0.1-mmol/kg dose and aid in patient diagnosis and treatment. 49 refs., 7 figs., 4 tabs.
- OSTI ID:
- 50617
- Journal Information:
- AJNR. American Journal of Neuroradiology, Vol. 15, Issue 6; Other Information: PBD: Jun 1994
- Country of Publication:
- United States
- Language:
- English
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