Cathartic-Free DECT Colonography for Detection of Colonic Polyps

January 20, 2016 updated by: Jeff Fidler, Mayo Clinic

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.

Study Overview

Status

Terminated

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance of dual-energy CT colonography (CTC).
Time Frame: Three Months
Detection of polyps in cathartic-free CTC using optimized dual-energy techniques.
Three Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jeff L. Fidler, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

January 4, 2008

First Posted (Estimate)

January 7, 2008

Study Record Updates

Last Update Posted (Estimate)

January 22, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 981-05
  • R21CA110390 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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