Characterisation of Central Nervous System, Liver, and Abdomino-Pelvic Tumours using Meglumine Gadoterate: Pooled Phase III Studies.

Abstract

Aim: To compare the diagnostic performance of Gd-DOTA-enhanced MRI with non-enhanced MRI in the characterization of tumoral lesions with histological (or other) corroboration.Materials and Methods: Pooled data included 381 patients from three comparable Phase III trials of patients with abdomino-pelvic, hepatic and cerebro-spinal lesions. Each patient underwent MRI with appropriate unenhanced sequences (pre), followed by an injection of Gd-DOTA (0.1 mmol/kg) and corresponding enhanced sequences (post). Histology was used as the gold standard or, in the hepatic study, a corroborative diagnosis. Qualitative and quantitative assessments of images were done by one on-site and two independent off-site blinded readers.Results: Technical failures were at least five times more frequent on the unenhanced sequences compared with the GdDOTA-enhanced sequences. Delineation of lesion borders was superior with enhanced MRI compared with unenhanced MRI, irrespective of evaluation off-site (‘post’-injection/‘pre+post’-injection: 60.9%/65.3% versus ‘pre’-injection: 35.5%, p<.0001) or onsite (post: 75.8%, versus pre: 39.9%, p<.0001). Gd-DOTA sequences improved diagnostic confidence both off-site (76.2%/83.2% versus pre: 57.6%, p<.0001) and on-site (88.7%/93.9% versus pre: 43.9%, p<.0001). Sensitivity and specificity were statistically significantly improved with Gd-DOTA for off-site (pre+post/post: 90.3%/88.8% versus pre 84.3%; and 71.1%/76.2% versus 65.3%) and on-site (95.2%/94.7% versus 71.2% and 81.9%/81.0% versus 60.8%) readings, respectively. There were no unexpected adverse events.Conclusion: Gd-DOTA-enhanced MRI resulted in fewer technical failures, better image quality and better diagnostic performance compared with unenhanced MRI, confirming that Gd-DOTA adds clinical value and greater diagnostic confidence to the characterization of tumoral lesions.