ACR Image Metrix Is Selected As Imaging CRO In Aegerion Pharmaceuticals Groundbreaking, Randomized Clinical Trial
American College of Radiology (ACR) Image Metrix™ was chosen by Aegerion Pharmaceuticals for a groundbreaking, randomized clinical trial testing the efficacy and safety of an MTP inhibitor because of its unique capabilities in employing novel imaging technologies in drug development trials.
Sponsored by Aegerion Pharmaceuticals, a double-blind and placebo-controlled parallelgroup study was conducted to evaluate the improvement in hyperlipidemic patients given low doses of the MTP-inhibitor AEGR-733. The primary objective for ACR Image Metrix was to evaluate the impact of low-dose AEGR-733 as monotherapy and in combination with established lipid-lowering on hepatic fat accumulation measured by MRS/MRI. A secondary objective was to assess the correlation between hepatic fat measurements obtained by MRS (the more standard approach) and those generated from the MRI scans in the same patients.
A total of 696 participants were screened for eligibility, of which 460 underwent a screening MRS/MRI scan and 260 were randomized for treatment. During the 11 months of the trial, ACR Image Metrix trained and qualified 17 radiology sites identified by the clinical CRO, PharmaNet, to perform the imaging part of the protocol. ACR Image Metrix received the 1,405 MRS and 1,417 MRI scans from the sites, then archived image and non-image data into its clinical trials management system. ACR Image Metrix researchers and staff evaluated images for quality and protocol adherence then analyzed the data using a novel data processing software, (ACORN) NUTS, validated by ACR Image Metrix for this purpose.
"This is one of the largest studies to utilize MRS and MRI for the quantification of hepatic fat and certainly one of the first to do multiple serial measurements," stated Aegerion Pharmaceuticals Chief Medical Officer, William Sasiela, Ph.D. "ACR Image Metrix did an extraordinary job of qualifying and training the radiology labs to a standard protocol, then collecting, analyzing, and archiving over 2,800 separate images. The process was well-designed and well-managed from start to finish."
ACR Image Metrix provided a comprehensive range of services – utilizing new MRS and MRI techniques – and handled all aspects of the images themselves, including archiving, image interpretation/quantitation and processing and delivery. While AEGR-733 is still in the midst of clinical development, the methodology of utilizing MRS or MRI to measure hepatic fat was determined to be efficient and effective, and in that regard, the study was agreed by all of the involved parties to be a success.
About ACR Image Metrix
ACR Image Metrix, located in the American College of Radiology Clinical Research Center, applies imaging
techniques as a predictive and prognostic biomarker improving the efficiency for drug development programs. The world-class team of physicians and scientists at ACR Image Metrix work with pharmaceutical, biotech and medical device companies to increase the efficiency of drug and device development programs by integrating the appropriate imaging modalities. ACR Image Metrix has years of experience and proven expertise in employing state-of-the-art technologies provide a complete line of imaging services.
SOURCE: ACR Image Metrix