Intrinsic Imaging has been awarded a clinical trial to study an interventional medical device designed for the percutaneous ablation of cancerous tumors.
The company 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 also will provide guidance to the study's 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 killing tumors. 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., president/chief operating officer of 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 brands itself as 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, executives note.
Located in Bolton, Mass., 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, 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 60 full-time, board-certified diagnostic radiologists on staff that have sub-specialization in various therapeutic areas including cardiovascular, central nervous system, gastrointestinal and genitourinary, medical device, musculoskeletal and oncology.