Intrinsic Imaging Awarded Pivotal Phase III Trial to Assess Novel Oral Chemotherapeutic for Metastatic Breast Cancer
Bolton (MA), San Antonio (TX) October 5, 2015
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 a pivotal Phase III clinical trial designed to compare the safety, tolerability and tumor response of a new oral chemotherapeutic versus the leading therapy for the treatment of metastatic breast cancer.
Throughout this trial, which includes over 5,500 radiological reads, Intrinsic Imaging will provide comprehensive imaging core lab services including, but not limited to, protocol and charter development, site qualification, site training and management, image transfer and processing.
In addition, Intrinsic Imaging’s full time board certified fellowship trained radiologists will also evaluate the patients’ tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
According to American Cancer Society 2015 statistics, female breast cancer will account for greater than 230,000 (29%) of all new cancer cases in women, making it the most common cancer diagnosed in women in the United States. Further, breast cancer is also one of the leading causes of cancer death in women, and will account for greater than 40,000 (15%) of all cancer mortality in 2015.
“The outcome of this pivotal Phase III study will determine if this new treatment compares favorably with the leading metastatic breast cancer therapy, ” said Todd A. Joron, President & COO at Intrinsic Imaging. “At Intrinsic Imaging, we are very proud to provide our expertise in assessing if this new treatment could bring renewed hope for those facing the challenge of having metastatic breast cancer.”
Intrinsic Imaging’s more than sixty board-certified fellowship training radiologists have fellowship training in all subspecialty therapeutic areas including Oncology. Intrinsic Imaging’s Oncology team consists of 12 full-time board-certified, fellowship trained radiologists all of whom have significant expertise in the evaluation of many cancers including but not limited to breast, cervical, lymphoma, colorectal, gastric, head and neck, hepatocellular, liver, lung, melanoma, ovarian, pancreas, prostate, renal cell, sarcomas and thyroid.
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 medical imaging core lab specializing in providing imaging core lab services for clinical trials. With its team of more than sixty board-certified fellowship trained radiologists, robust and scalable clinical imaging technologies and our ISO certified and registered quality management systems, Intrinsic Imaging is ideally positioned to provide unprecedented imaging core lab services around the world.