Colonic PolypsNCT00587028
Cathartic-Free DECT Colonography for Detection of Colonic Polyps
An observational study of Colonic Polyps, run by Mayo Clinic at 2 sites in United States.
Trial summary
Asses the clinical performance of dual-energy CTC for the detection of larger polyps 1 cm or larger without cathartic preparation. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Colonic Polyps
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2007to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mayo Clinic, Rochester, Minnesota and Mayo Clinic, Scottsdale, Arizona Colonoscopy schedules.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic
Scottsdale, Arizona, 85259
About this study
Official title: 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.
Read the 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.
- Conditions
- Colonic Polyps
- Keywords
- Colonography, Colonoscopy, Virtual, Computed Tomographic Colonography, Large intestine, colon
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of dual-energy CT colonography (CTC).
Detection of polyps in cathartic-free CTC using optimized dual-energy techniques.
Measured: Three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startFeb 2007
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Administrative closed due to funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jeff Fidler, Mayo Clinic
- Investigators
- Jeff L. Fidler, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587028
- Sponsor's protocol ID
- 981-05
- Other IDs
- R21CA110390
- Status last verified
- Jan 2016
- First submitted
- 21 Dec 2007
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cathartic-Free Dual Energy Computerized Tomography (DECT) Colonography.
- ClinicalTrials.gov ID
- NCT00587028
- Acronym / sponsor ID
- 981-05
- Conditions
- Colonic Polyps
- Keywords
- Colonography, Colonoscopy, Virtual, Computed Tomographic Colonography, Large intestine, colon
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Administrative closed due to funding
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asses the clinical performance of dual-energy CTC for the detection of larger polyps 1 cm or larger without cathartic preparation.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mayo Clinic, Rochester, Minnesota and Mayo Clinic, Scottsdale, Arizona Colonoscopy schedules.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- Pregnant females.
- Presence of colostomy or right hemicolectomy.
- Inflammatory bowel disease (Crohn's, chronic ulcerative colitis).
- Familial polyposis syndrome.
- Pregnant female.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical performance of dual-energy CT colonography (CTC).
Time frame: Three Months
Detection of polyps in cathartic-free CTC using optimized dual-energy techniques.
Results and safety
The study was stopped early (reason given: Administrative closed due to funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff L. Fidler, M.D. principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Polyps, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Administrative closed due to funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance of dual-energy CT colonography (CTC). (time frame: Three Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2016.