Clinical Trials

Unprepped CT Colonography

Location:

Trial status:

Closed

Why is this study being done?

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.

Who is eligible to participate?

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

What is involved?

-Patients will take a contrast agent by mouth two days before the study day.
-The day before the study day, the patient will be asked to drink an oral contrast agent containing iodine, as well as taking the barium capsules.
-On the day of the study patients will take some more of the barium capsules.
-One hour before the CT Colonography, patients will drink 8 ounces of liquid barium.
-On the day of the CT Colonography scan; patients will come to the CT area to complete the procedure.
-No blood draws are required.
-Patients will be asked to complete a written questionnaire at least 12 hours after they have had their colonoscopy. The researchers will give the patient a pre-paid postage envelope to return it to the research staff.

How long is the study?

Patients will be in the study for no more than 30 days. They will have the CT examination and within 30 days have their colonoscopy.

Sponsor(s): Mayo Clinic

Study Activation/Registration Date: 08/07/2007

IRB Review and Approval Date: 02/02/2007

Study Type: Screening

Projected Accrual: The plan is to have up to 1255 patients participate at Mayo Clinic.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Charles D. Johnson, MD

Last updated: 02/10/2010

NCT ID:

NCT00586053