Cathartic-Free DECT Colonography for Detection of Colonic Polyps



Status:Terminated
Conditions:Colorectal Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:40 - 99
Updated:4/21/2016
Start Date:February 2007
End Date:December 2008

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Cathartic-Free Dual Energy Computerized Tomography (DECT) Colonography.

Asses the clinical performance of dual-energy CTC for the detection of larger polyps 1 cm or
larger without cathartic preparation.

Determine the feasibility to differentiate polyps from stool with or without the use of
contrast agents and to assess the feasibility and accuracy of dual energy techniques in a
pilot patient study.

1.1 Formulate algorithms that use dual-energy information to quantitatively measure specific
material density of colon polyps in physics based simulation.

1.2 Determine optimal scanning parameters on prototype CT equipment.

2.1 Measure the material composition density and Hounsfield number of polyps with and
without simulated contrast enhancement.

2.2 Measure the accuracy of dual-energy techniques to differentiate between polyps and stool
and if needed using a combination of simulated intravenous enhanced polyps and contrast
material tagged stool.

3.0 Asses the clinical performance of dual-energy CTC for the detection of larger polyps 1
cm or larger without cathartic preparation.

Inclusion Criteria:

- Participants with a known colorectal polyp or colon carcinoma with pathology, at or
greater than 1 cm in size on a colonoscopy that is completed either eight weeks
before or after CT Colonography study visit.

- If receiving iodine oral or IV contrast, must have a creatinine less than 1.4 on
record within last 30 days of study visit date. If no creatinine is available, one
will be drawn for enrollment criteria purposes.

Exclusion Criteria:

- Pregnant females.

- Presence of colostomy or right hemicolectomy.

- Inflammatory bowel disease (Crohn's, chronic ulcerative colitis).

- Familial polyposis syndrome.

- Pregnant female.

- Creatinine at or greater than 1.4

- Severe or uncontrolled chronic obstructive pulmonary disease (COPD) or chronic
obstructive lung disease (COLD).

- Iodine contrast allergy.
We found this trial at
2
sites
Scottsdale, Arizona 85259
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from
Scottsdale, AZ
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Rochester, Minnesota 55905
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Rochester, MN
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