The National CT Colonography Trial

Protocol Documents 

Protocol-ACRIN 6664 Administrative Amendment to Amendment 2, 8.4.10 [PDF]

SOC-ACRIN 6664 Administrative Amendment to Amendment 2, 8.4.10 [PDF]

SOC-ACRIN 6664 Amendment 2, 7.7.06 [PDF]

Principal Investigator: C. Daniel Johnson, MD

Status: Accrual Complete; Primary-Aim Paper in Process

Main Objective: To clinically validate widespread use of computerized
tomographic colongraphy (CTC) in a screening population for the detection
of colorectal neoplasia.

Study Design Summary: 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: Male and female outpatients, aged 50 years or older, scheduled
for screening colonoscopy, who have not had a colonoscopy in the past 5 years.