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Clinical Trials

Screening and Interventional Clinical Trials

Screening should identify cancers at an early stage, before they are clinically evident. Treatment would therefore be more effective, surgery less disfiguring, and there would be a greater likelihood that the cancer will not have spread. To be valid, a screening tool must be easy, convenient, cost-effective, widely available and safe, and it must show a benefit for the participant. With NCI support, the American College of Radiology Imaging Network (ACRIN) has conducted a number of screening trials.

The National CT Colonography Trial is sponsored by the National Cancer Institute to clinically validate widespread use of computerized tomographic colongraphy (CTC) in a screening population for the detection of colorectal cancer. The study addresses aspects of central importance to the clinical application of CTC in several inter-related but independent parts that will be conducted in parallel. In Part I, the clinical performance of the CTC examination will be prospectively compared in a blinded fashion to colonoscopy. In Part II Optimization of the CT Technique will be performed in view of new technological advances in CT technology. In Part III, lesion detection will be optimized by studying the morphologic features of critical lesion types and in the development of a database for computer-assisted diagnosis. In Part IV, patient preferences and cost-effectiveness implications of observed performance outcomes will be evaluated using a predictive model. Participants will be male and female outpatients, aged 50 years or older, scheduled for screening colonoscopy, who have not had a colonoscopy in the past 5 years. See Investigator Protocol Information about the CTC Trial, ACRIN 6664: Protocol Summary Table

The National Lung Screening Trial (NLST) is a lung cancer screening trial sponsored by the National Cancer Institute (NCI). NLST is a prospective, randomized trial designed to determine if lung cancer screening using spiral CT reduces lung cancer-specific mortality compared to screening with standard chest X-ray. Launched in 2002, it enrolled 50,000 high risk participants 55-74 years of age and completed accrual in early 2004. In addition to the CT scans and chest X-rays that all the centers will do, some - those that are part of a cooperative group sponsored by the American College of Radiology Imaging Network (ACRIN) - will also collect samples of participants' blood, urine, or sputum for biomarker studies. NLST methodology includes evaluation of quality of life issues and the impact of screening on smoking cessation.

The Digital Mammographic Imaging Screening Trial (DMIST) is a research study sponsored by the National Cancer Institute (NCI). To compare digital mammography to conventional screen-film mammography for sensitivity, specificity, and positive and negative predictive value, a prospectively enrolled cohort of asymptomatic women were utilized. The American College of Radiology Imaging Network (ACRIN) coordinated the study and announced in late 2003 that DMIST had reached its target 49,500 participant recruitment goal. Radiologists participating in the research project now will use the DMIST data and images to carry out studies related to the diagnostic accuracy of both digital and conventional mammography. In addition, DMIST researchers will measure the relative cost-effectiveness of both technologies and their effect on patient quality of life. DMIST recruitment is complete, as of August 2005.
Published results can be found here.

The American College of Radiology Imaging Network (ACRIN) supports the development and conduct of clinical trials in imaging diagnosis and therapy. Information about the development of protocols, the status of protocols under development and in process can be found on the ACRIN Web site. Particularly, consult the Protocol Summary Table section.