Viewing Study NCT00005809



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Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00005809
Status: COMPLETED
Last Update Posted: 2013-02-04
First Post: 2000-06-02

Brief Title: Computerized Tomographic Colonography Compared With Standard Diagnostic Procedures in Detecting Colorectal Neoplasia
Sponsor: American College of Radiology Imaging Network
Organization: American College of Radiology Imaging Network

Study Overview

Official Title: Computerized Tomographic Colonography Performance Evaluation in a Multicenter Setting
Status: COMPLETED
Status Verified Date: 2013-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ACRIN 6656
Brief Summary: RATIONALE New diagnostic procedures such as computed tomographic colonography may provide a less invasive method of identifying patients who have colorectal neoplasia

PURPOSE Diagnostic study to compare the effectiveness of computerized tomographic colonography with that of standard diagnostic procedures in detecting colorectal neoplasia
Detailed Description: OBJECTIVES I Compare retrospectively the accuracy of computerized tomographic colonography CTC vs pathology and colonoscopy in the detection of clinically important colorectal neoplasia defined as at least one proven lesion with a diameter measuring at least 1 cm II Compare the physician image display preferences and interpretation time across three viewing platforms for CTC images

OUTLINE This is a retrospective multicenter study Radiologists evaluate each patients optimal diagnostic computerized tomographic colonography CTC data Patients CTC findings are evaluated by a radiologist at a central facility using an imaging display software platform from General Electric Vital Images or the Mayo Clinic CTC findings are compared with conventional colonoscopy findings and pathologic analysis A comparison is made between physician image display preferences and interpretation time across three viewing platforms for CTC images

PROJECTED ACCRUAL A total of 90 patients will be accrued for this study

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
CA80098 OTHER_GRANT NCI CIP None
ACRIN-6656 None None None