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

摘要

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 Gd-DOTA-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 on-site (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. Introduction Magnetic resonance imaging (MRI) is a well established technique for imaging tumours. However, some tumours may appear isointense making differentiation from surrounding tissue difficult and enhancement agents are often used to provide greater delineation and characterization of these lesions (1-5). Identification of tumours in the abdomen, pelvis, brain and spine present their own specific problems. Cross-sectional imaging of the abdomino-pelvic region offers important advantages over CT and is of particular value in the diagnosis and management of paediatric abdominal masses (6, 7). MRI of the liver is made easier by the use of contrast agents, which improve lesion detection and characterization by increasing lesion to liver contrast, including many types of extrahepatic tumour (8, 9). Rapid breath-hold imaging techniques have been used with intravenous and intraluminal contrast media to demonstrate tumours of the solid visceral organs, the gastrointestinal tract, peritoneum, mesentery, omentum, bile ducts, lymph nodes, and osseous structures. MRI is also considered to be the modality of choice for the evaluation of most patients presenting or suspected of having cerebral or spinal tumours in terms of both detection and differential diagnosis (10).Gadoterate meglumine (Gd-DOTA; Magnescope in Japan; Dotarem in other countries; Guerbet, Roissy CdG Cedex, France) is a commonly used enhancement agent and its safety has been well documented in clinical practice (11, 12). Efficacy has largely been judged by reader evaluation of the image, which is a subjective measure and has rarely been corroborated. Furthermore, a large variation in response has been observed between scanner types and this may impact upon the heterogeneity of overall efficacy (13).This study evaluates a heterogeneous population by pooling data from three comparable Phase III studies. The aim of this analysis was to compare the diagnostic performance of Gd-DOTA-enhanced MRI with non-enhanced MRI in the characterization of tumoral lesions using histology or a corroborative diagnosis (hepatic patients only) as th