Located in Bolton, MA, and San Antonio, TX, Intrinsic Imaging LLC is an FDA audited, ISO 9001:2008, ISO 13485:2003, and ISO 22301:2012 certified, GAMP® 5 medical imaging core lab that specializes in providing imaging core lab services for clinical trials. Intrinsic has a team of more than 60 board-certified diagnostic radiologists, making it ideally positioned to provide imaging core lab services globally. The company announced yesterday that it has been awarded a global clinical trial to assess patients with hepatocellular carcinomas (HCC).
Intrinsic will be providing comprehensive imaging core lab services, which include, but are not limited to, protocol and charter development, site qualification, site training and management, image transfer, blinding and processing, as well as the specialized radiologic review of images using Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI).
Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) allows for analysis of blood vessels in a tumor. The system uses a contrast agent that is blocked by the blood-brain-barrier but is not blocked in blood vessels that are generated by a tumor. Images that are taken are MRI T1-weighted after an intravenous injection of gadolinium. The contrast agent (gadolinium) concentration is then measured when it passes from the blood vessels in the tumor to the extracellular space and whether it goes back to the blood vessels. Gadolinium causes the relaxation time to decrease so images come out having a higher contrast.
The first scan is a regular T1-weighted MRI scan with no gadolinium and then gadolinium is injected and another T1-weighted scan is done. These two scans are then compared for each voxel. By doing so, one can identify permeable blood vessels and tissue with active tumors. If the tissue has many healthy cells, gadolinium gets back to the bloodstream since it cannot enter cells. If the tissue is damaged (tumor) and there are fewer cells, gadolinium remains in the extracellular space and gets out of the blood vessels slowly making for an excellent imaging protocol for tumors.
Hepatocellular carcinoma (HCC) is the most common type of liver cancer in many countries with more than 700,000 individuals diagnoses annually globally, according to the American Cancer Society. Many cases of HCC are secondary to either a viral hepatitis infection (B or C) or cirrhosis (usually alcoholism). The highest incident of HCC is in Asia and Africa where hepatitis B and C predisposes individuals to chronic liver disease that leads to hepatocellular carcinoma.
According to Todd A. Joron, BSc. MBA, President and Chief Operating Officer, Intrinsic Imaging, “Intrinsic Imaging is dedicated to applying our therapeutic and regulatory expertise throughout this clinical trial towards assisting in the development of a new effective therapy to treat patients with hepatocellular carcinomas.”