Cathartic-Free DECT Colonography for Detection of Colonic Polyps

NCT00587028 | Terminated

• 2 other identifiers: 981-05R21CA110390
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Colonic Polyps

Keywords

Colonography; Colonoscopy; Virtual; Computed Tomographic Colonography; Large intestine; colon

Outcome Measures

Primary Outcomes (1)

• Clinical performance of dual-energy CT colonography (CTC).

  Detection of polyps in cathartic-free CTC using optimized dual-energy techniques.

  Three Months

Study Arms (4)

Oral Omnipaque MCA

Ten participant minimum: for stool tagging two days preceding the CT colonography, if applicable, with oral Omnipaque. This cohort at Scottsdale Mayo Clinic only.

IV Iodine MCR

Ten participant minimum: for intravenous iodine contrast dye. This cohort at Rochester Mayo Clinic only.

NO oral and no IV MCR

Five participant minimum for no oral or IV contrast.

Replacement Group

Five participant minimum for either cohorts 1, 2, or 3 as above should there be poor imaging results. A like prepped participant will replace that who had poor quality imaging to meet 25 imaging data sets.

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mayo Clinic, Rochester, Minnesota and Mayo Clinic, Scottsdale, Arizona Colonoscopy schedules.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeff L. Fidler, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: February 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 22, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)