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


N/A
40 Years
N/A
Not Enrolling
Both
Colonic Polyps

Thank you

Trial Information

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


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 COPD or COLD.

- Iodine contrast allergy.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Jeff L. Fidler, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

981-05

NCT ID:

NCT00587028

Start Date:

July 2005

Completion Date:

December 2008

Related Keywords:

  • Colonic Polyps
  • Colonography
  • Colonoscopy
  • Virtual
  • Computed Tomographic Colonography
  • Large intestine
  • colon
  • Colonic Polyps

Name

Location
Mayo Clinic Rochester, Minnesota  55905
Mayo Clinic Scottsdale, Arizona