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Phase II Clinical Trial of Gadoteridol Injection, a Low-Osmolal Magnetic Resonance Imaging Contrast Agent

Phase II Clinical Trial of Gadoteridol Injection, a Low-Osmolal Magnetic Resonance Imaging Contrast Agent

M J Carvlin, D N De Simone, M J Meeks

Invest Radiol. 1992 Aug;27 Suppl 1:S16-21.

PMID: 1506148

Abstract:

Rationale and objectives:
The safety and efficacy of a new, low-osmolal magnetic resonance imaging contrast medium, gadoteridol injection, were evaluated in a phase II, open-label study at doses ranging from 0.05 to 0.30 mmol/kg.
Methods:
Eighty-six patients with a diagnosis of intracranial tumor received gadoteridol injection followed by magnetic resonance imaging.
Results:
Two adverse events (headache, taste disturbance) in 2 of 86 (2.3%) patients were reported. Both were of mild intensity and resolved without treatment and without residual effects. In 4 of 86 (4.7%) patients, 5 laboratory changes were reported by the investigators as possibly related to gadoteridol injection. Efficacy evaluation was conducted in 80 of the 86 patients who received gadoteridol injection. In these patients, a total of 119 lesions was identified, and each was evaluated at four time points after contrast administration, yielding a total of 476 lesion studies. Marked enhancement was demonstrated in 402 of 476 (84%) lesions, whereas slight enhancement was demonstrated in 62 of 476 (13%) lesions. The difference in both the incidence and degree of enhancement of pathology between the predose and postdose images was highly significant (P less than .001).
Conclusions:
Overall, enhanced images provided more diagnostic information and facilitated detection of more lesions than precontrast images. Gadoteridol injection at doses up to 0.3 mmol/kg is a safe and effective magnetic resonance imaging contrast agent for use in patients with intracranial tumors.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP120041089	Gadoteridol Related Compound A		120041-08-9	Price

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