Phase II clinical trial of gadoteridol injection, a low-osmolal magnetic resonance imaging contrast agent.

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.

• Authors: M J Carvlin, D N De Simone, M J Meeks
• Journal: Investigative radiology (Invest Radiol) Vol. 27 Suppl 1 Pg. S16-21 (Aug 1992) ISSN: 0020-9996 [Print] United States
• PMID: 1506148 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Contrast Media
• Heterocyclic Compounds
• Organometallic Compounds
• gadoteridol
• Gadolinium

Topics

• Adult
• Aged
• Brain (pathology)
• Brain Neoplasms (diagnosis)
• Contrast Media (administration & dosage)
• Dose-Response Relationship, Drug
• Drug Evaluation
• Drug Tolerance
• Gadolinium (administration & dosage)
• Heterocyclic Compounds (administration & dosage)
• Humans
• Magnetic Resonance Imaging
• Middle Aged
• Organometallic Compounds (administration & dosage)
• Time Factors