Intrinsic Imaging, an FDA audited, ISO 9001:2008 and ISO 13485:2003 certified, GAMP® 5 compliant, imaging core lab, announced today that it has been awarded an international Phase II clinical trial to assess a new treatment for patients with glioblastoma multiforme (GBM).
Glioblastoma multiforme (GBM) is the most common and most aggressive malignant type of primary brain tumor (gliomas). With the exception of the brainstem gliomas, glioblastoma multiforme has the most severe prognosis of any central nervous system malignancy.
There are many ongoing clinical trials designed to evaluate treatment regimens for gliomas and in particular glioblastoma multiforme brain tumors; however determining reliable imaging endpoints in clinical trials remains very problematic. This is a result of the inherent growth characteristics of primary brain tumors, which demonstrate extensive infiltration of the surrounding normal brain. From an imaging perspective, this often results in an imperceptible transition from normal brain to areas of gross tumor involvement.
Throughout this trial, Intrinsic Imaging will provide comprehensive imaging core lab services. Most importantly these services include the development of the imaging charter, providing guidance to the sponsor on the best methodology for image acquisition and guiding the most reliable imaging endpoints to ensure correct radiologic assessment of glioblastoma multiforme brain tumors. During the execution of this trial, the Intrinsic Imaging radiologists will employ their subspecialty neuro-imaging expertise by utilizing the Response Assessment in Neuro-Oncology (RANO) criteria to ensure the optimal measurement of the effect of treatment.
“Intrinsic Imaging’s more than sixty full time board-certified radiologists have fellowship training in all subspecialty therapeutic areas,” said Todd A. Joron, BSc. MBA, President and Chief Operating Officer, Intrinsic Imaging. “Our team includes full time fellowship trained board certified neuroradiologists who specialize in all brain and spine pathology.“
Clinical trials involving disorders of the Central Nervous System (CNS) present a number of challenges. A wealth of domain knowledge utilizing validated scoring methods in centralized image processing and analysis for all necessary modalities and techniques is required. Of the more than 1 million images reviewed annually by Intrinsic Imaging radiologists, 400,000 images are central nervous system related. Intrinsic Imaging’s CNS team possesses broad experience and expertise in MRI, CT, diagnostic and interventional angiographic procedures, as well as PET imaging using novel CNS markers.
About Intrinsic Imaging, LLC
Located in Bolton, Massachusetts and San Antonio, Texas, Intrinsic Imaging is an FDA audited, ISO 9001:2008 and ISO 13485:2003 certified, GAMP® 5 compliant medical imaging core lab specializing in providing imaging core lab services for clinical trials. Its comprehensive medical imaging core lab services include, but are not limited to, expert radiologist consultation, protocol and charter development, site qualification, training and management, as well as image acquisition, processing and detailed radiologic analysis.
Intrinsic Imaging has more than sixty full-time, board-certified diagnostic radiologists on staff that have sub-specialization in all therapeutic areas including, but not limited to, Cardiovascular, Central Nervous System, Gastrointestinal & Genitourinary, Medical Device, Musculoskeletal and Oncology.