Intrinsic Imaging Awarded Medical Device Trial for Percutaneous Tumor Ablation
Bolton (MA), San Antonio (TX), April 23, 2015
Intrinsic Imaging, an FDA audited, ISO 9001:2008 and ISO 13485:2003 certified, GAMP® 5 compliant medical imaging core lab specializing in providing services for clinical trials, announced today that it has been awarded a clinical trial to study an interventional medical device designed for the percutaneous ablation of cancerous tumors.
Intrinsic Imaging will provide comprehensive imaging core lab services. As the evaluation of loco-regional ablative techniques require significant expertise in multimodalablation zone evaluation, Intrinsic Imaging’s board certified fellowship trained interventional radiologists will also provide guidance to the Sponsor on the imaging charter, optimal image acquisition parameters and the most reliable and reproducible imaging endpoints to assess pre and post tumor ablation findings.
Image-guided percutaneous tumor ablation is a technique of controlled, direct destruction of cells and tissue with the end goal of complete tumor destruction. Ablative therapy can be performed for both primary and metastatic tumors. The spectrum of ablation therapy encompasses techniques such as radiofrequency ablation (RFA), cryoablation, , laser ablation, microwave ablation, high-intensity focused ultrasound, and irreversible electroporation.
“Clinical trials requiring the use and evaluation of tumor ablation medical devices present a number of challenges for a Sponsor,” said Todd A. Joron, BSc. MBA, President and Chief Operating Officer, Intrinsic Imaging. “Our team of full time radiologists have significant experience with medical devices for percutaneous tumor ablation have a wealth of expertise in the complex assessment of tumors treated by various ablative therapies.”
Intrinsic Imaging is the only imaging core lab that is ISO 13485 certified specifically to provide quality services for medical device clinical trials. The company’s team of full-time, board-certified, fellowship-trained interventional radiologists have experience assessing medical devices including, but not limited to, catheters, stents, angioplasty balloons, thrombectomy devices, venous access tools, novel devices and biologics.
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.