Unprepped CT Colonography

CTC of the Unprepped Colon: Optimization & Validation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00586053

Enrollment

1255

Registered

2008-01-04

Start date

2000-08-31

Completion date

2009-12-31

Last updated

2010-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Keywords

Colonic Polyps, Colon, Large Intestine, Cecum, Sigmoid, Rectum, Colonoscopy, Virtual Colonoscopy, CT Colonography, Computed Tomographic Colonography, Colonography

Brief summary

It is our objective to improve the performance of CTC in the prepared colon, and to validate CTC in the unprepared colon for the detection of colorectal neoplasia. The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening test.

Detailed description

To improve the diagnostic performance of CTC in the prepared colon using improved spatial resolution, advanced image displays, and computer-assisted diagnosis, and to optimize diagnostic performance of CTC in the unprepared colon for colorectal polyp detection using electronic stool subtraction and computer-aided diagnostic techniques. To estimate the sensitivity and specificity of CTC in the unprepared colon for clinically important colorectal neoplasms (large adenomas ≥ 1 cm) and to compare such estimates with colonoscopy. To survey patient acceptance of CTC in the unprepared colon, and to assess implications for health care costs and cost-effectiveness of CTC in the unprepared colon in comparison with other approaches.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Average risk or higher for colorectal cancer and scheduled for colonoscopy with any of the following indications: * Prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency. * Age ≥ 40 -100 years * Known or highly suspected primary colorectal neoplasms \> 10 mm (n = 160) * Higher than average risk for colorectal cancer and scheduled for colonoscopy with any of the following indications: prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency.

Exclusion criteria

* Less than 1/2 of colorectum remaining * Inflammatory bowel disease (Crohns, Chronic Ulcerative Colitis) * Familial Polyposis * Melena, hematochezia

Design outcomes

Primary

Measure	Time frame
To optimize diagnostic performance of CTC in the unprepared colon for colorectal polyp detection using electronic stool subtraction and computer-aided diagnostic techniques.	2000-2009

Secondary

Measure	Time frame
The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening tests	2000-2009

Countries

United States

Outcome results