Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084929
Status:
COMPLETED
Last Update Posted:
2020-12-22
First Post:
2004-06-10
Brief Title:
The National CT Colonography Trial
Sponsor:
American College of Radiology Imaging Network
Organization:
American College of Radiology Imaging Network
Study Overview
Official Title:
The National CT Colonography Trial Multicenter Assessment of Accuracy for Detection of Large Adenomas and Cancers in a Healthy Screening Population
Status:
COMPLETED
Status Verified Date:
2020-11
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:
ACRIN6664
Brief Summary:
RATIONALE New diagnostic procedures such as computed tomographic colonography may improve the ability to detect colorectal cancer and may provide a less invasive method of detection
PURPOSE This clinical trial is studying how well computed tomographic colonography works in screening healthy participants for colorectal cancer
PURPOSE This clinical trial is studying how well computed tomographic colonography works in screening healthy participants for colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Compare the sensitivity of computed tomographic colonography CTC vs colonoscopy for detecting significantly large lesions 10 mm in diameter in asymptomatic participants in terms of specificity area under the ROC curve and predictive values for detecting clinically significant colorectal neoplasia
Secondary
Determine the interobserver variation in accuracy of interpreting CTC examinations of these participants including any benefits of a primary 3-dimensional read andor independent second interpretations
Determine the effects of different colon preparations on the accuracy of CTC in these participants
Compare participant acceptance and willingness to have a repeat examination by CTC vs colonoscopy
Determine the accuracy of CTC in detecting flat lesions in the colon of these participants
OUTLINE This is a multicenter study
Participants receive an oral laxative oral bisacodyl and three doses of oral barium sulphate 24 hours before imaging After cathartic cleansing participants undergo computed tomographic colonography followed by colonoscopy
Participants are followed up for approximately 4 weeks
PROJECTED ACCRUAL A total of 2607 participants will be accrued for this study
Primary
Compare the sensitivity of computed tomographic colonography CTC vs colonoscopy for detecting significantly large lesions 10 mm in diameter in asymptomatic participants in terms of specificity area under the ROC curve and predictive values for detecting clinically significant colorectal neoplasia
Secondary
Determine the interobserver variation in accuracy of interpreting CTC examinations of these participants including any benefits of a primary 3-dimensional read andor independent second interpretations
Determine the effects of different colon preparations on the accuracy of CTC in these participants
Compare participant acceptance and willingness to have a repeat examination by CTC vs colonoscopy
Determine the accuracy of CTC in detecting flat lesions in the colon of these participants
OUTLINE This is a multicenter study
Participants receive an oral laxative oral bisacodyl and three doses of oral barium sulphate 24 hours before imaging After cathartic cleansing participants undergo computed tomographic colonography followed by colonoscopy
Participants are followed up for approximately 4 weeks
PROJECTED ACCRUAL A total of 2607 participants will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| U01CA080098 | NIH | CIP | httpsreporternihgovquickSearchU01CA080098 |
| ACRIN-6664 | OTHER | None | None |
| U01CA079778 | NIH | None | None |