Colon CancerNCT00124163
Evaluation of Stool Tagging for Improved Patient Compliance
An observational study of Colon Cancer and Polyps, run by Center for Diagnostic Imaging at 1 site in United States.
Trial summary
Computed tomography (CT) colonography has gained widespread multi-disciplinary interest as an evolving noninvasive colorectal screening examination, with the potential of improved patient compliance. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Polyps
- What is being tested?
- Imaging procedure of CT colonography
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to not given
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are 45 to 80 years old for routine screening colonoscopy
Who cannot join
- Patients with inflammatory bowel disease
- Patients with polyposis syndromes
- Pregnant women
- Patients over 350 pounds
- Patients with bright red blood per rectum
- Patients who have a contraindication to undergo outpatient colonoscopy, including patients on blood thinners, prior myocardial infarction (MI) in the last six months, history of congestive heart failure (CHF), history of arrhythmia, patients too weak to transfer themselves from a bed to a chair, or patients with severe constipation who would require a two day bowel preparation.
- All subjects will undergo informed consent by the St. Luke's institutional review board (IRB). Referred subjects will be asked if they are interested in the study and those responding affirmatively will be transferred to a recruiter to learn about the study and begin the consent process if interested.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Diagnostic Imaging Associates
Chesterfield, Missouri, 63017
Elizabeth G. McFarland, MD, 636-733-8911, McFarlandB@mir.wustl.edu
Elisabeth Quam-Berne, 952-525-6308, lquam@cdirad.com
About this study
Official title: CT Colonography Ph. I CDI Trial: Evaluation of Stool Tagging for Improved Patient Compliance
Computed tomography (CT) colonography has gained widespread multi-disciplinary interest as an evolving noninvasive colorectal screening examination, with the potential of improved patient compliance. The investigator's prior work demonstrated that the bowel preparation was the least tolerable aspect of colorectal evaluation when compared to the CT colonography and optical colonoscopy procedures. Stool tagging could provide a more gentle and efficient bowel preparation, with fewer false positives due to retained stool-mimicking polyps.
The researchers hypothesize that image quality and patient preference will vary with stool tagging concentration and dosing schedule. The researchers propose to evaluate specific stool tagging protocols with the following aims:
Read more
AIM 1: Perform a randomized trial of three specific stool tagging protocols using barium and iodine at CT colonography in a well-characterized cohort of patients undergoing colorectal evaluation.
AIM 2: Analyze the CT colonography and optical colonoscopy data to assess differences across stool tagging protocols for the outcome measures of patient preference, image quality in the presence of tagging, and diagnostic reader performance.
The researchers will use specific variations in stool tagging techniques to determine the best image quality of CT data (e.g., homogenous tagging of fluid and stool), and highest patient acceptability, as well as evaluate the adequacy of preparation for same-day colonoscopy. Diagnostic reader performance will focus on the accuracy for detecting all neoplastic lesions including colon cancers, adenomatous polyps, sessile adenomas and flat adenomas. Most importantly, these results will help inform the design of a larger trial of an optimized CT colonography technique in a community setting.
Read the detailed description
CT Colonography, a rapidly evolving technique, offers a noninvasive and efficient colorectal screening examination, with the potential to improve patient compliance. However, currently it requires the bowel preparation, one of the largest barriers to colonoscopy screening. A promising new tool in CT Colonography is stool tagging, which has the potential to decrease the amount of catharsis required by patients during the bowel preparation, while decreasing the number of false positives due to the reader mistaking residual stool for polyps.
Our primary hypothesis is that image quality and patient compliance differ depending upon the tagging agent and dosing schedule. Our strategy is to vary key components of recently reported barium and iodine protocols to further optimize them and to compare our results with existing and currently aggregating data in collaboration with other investigators.
The following aims will implement this strategy:
AIM 1: Perform a randomized control trial of specific stool tagging protocols at CT Colonography in a well characterized cohort of patients undergoing colorectal evaluation.
Task 1A - Recruit a prospective cohort of 60 subjects, randomize them equally to three different stool tagging protocols, and sequentially perform CT Colonography and optical colonoscopy on them.
Task 1B - Assess image quality of CT Colonography and optical colonoscopy data by the method of bowel preparation in the first five subjects of each arm and implement specific changes, if necessary.
AIM 2: Analyze the CT Colonography and optical colonoscopy data to assess differences across study arms for the outcome measures of patient preference, image quality of tagged stool, and diagnostic reader performance.
Task 2A: Assess patient expectations regarding the bowel preparations, CT Colonography and colonoscopy before the procedures and their preferences after the procedures.
Task 2B: Evaluate image quality, in the presence of tagged stool and fluid, of both the CT data and the colonoscopy data.
Task 2C: Perform a multi-observer reader evaluation of diagnostic performance of CT Colonography and colonoscopy, compared to the enhanced reference standard of colonoscopy aided by segmental unblinding of CT results, to assess sensitivity and specificity of colorectal polyp detection.
Upon completion, the three specific variations in stool tagging techniques will be compared on homogenous density of tagging and patient acceptability to determine which protocol optimizes the trade-off. Diagnostic performance of CT and colonoscopy will be compared to the enhanced reference standard of colonoscopy aided by the segmental unblinding of CT results. Most significantly, these results may help determine an optimal tagging protocol to use for larger trials of CT Colonography implementation in community settings.
- Conditions
- Colon Cancer, Polyps
- Being tested
- Imaging procedure of CT colonography
- Keywords
- CT Virtual Colonoscopy, Optical Colonoscopy, Stool Tagging, Patient Preparation
- Medical subject headings
- Colonic Neoplasms, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging procedure of CT colonographyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2005 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Center for Diagnostic Imaging
- Sponsor type
- University, hospital or other
- Investigators
- Elizabeth G. McFarland, MD, Principal investigator, St. Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124163
- Sponsor's protocol ID
- 633
- Status last verified
- Jan 2006
- First submitted
- 25 Jul 2005
- Last updated
- 2 Feb 2006
- Results posted
- No
Publications
Pickhardt PJ, Choi JR, Hwang I, Butler JA, Puckett ML, Hildebrandt HA, Wong RK, Nugent PA, Mysliwiec PA, Schindler WR. Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. N Engl J Med. 2003 Dec 4;349(23):2191-200. doi: 10.1056/NEJMoa031618. Epub 2003 Dec 1.
PubMed 14657426Iannaccone R, Laghi A, Catalano C, Mangiapane F, Lamazza A, Schillaci A, Sinibaldi G, Murakami T, Sammartino P, Hori M, Piacentini F, Nofroni I, Stipa V, Passariello R. Computed tomographic colonography without cathartic preparation for the detection of colorectal polyps. Gastroenterology. 2004 Nov;127(5):1300-11. doi: 10.1053/j.gastro.2004.08.025.
PubMed 15520999Lefere PA, Gryspeerdt SS, Dewyspelaere J, Baekelandt M, Van Holsbeeck BG. Dietary fecal tagging as a cleansing method before CT colonography: initial results polyp detection and patient acceptance. Radiology. 2002 Aug;224(2):393-403. doi: 10.1148/radiol.2241011222.
PubMed 12147834
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Colonography Ph. I CDI Trial: Evaluation of Stool Tagging for Improved Patient Compliance
- ClinicalTrials.gov ID
- NCT00124163
- Acronym / sponsor ID
- 633
- Conditions
- Colon Cancer, Polyps
- Keywords
- CT Virtual Colonoscopy, Optical Colonoscopy, Stool Tagging, Patient Preparation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Center for Diagnostic ImagingUniversity, hospital or other
- Study start
- Jul 2005
- First posted
- 27 Jul 2005 (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.
Computed tomography (CT) colonography has gained widespread multi-disciplinary interest as an evolving noninvasive colorectal screening examination, with the potential of improved patient compliance. The investigator's prior work demonstrated that the bowel preparation was the least tolerable aspect of colorectal evaluation when compared to the CT colonography and optical colonoscopy procedures. Stool tagging could provide a more gentle and efficient bowel preparation, with fewer false positives due to retained stool-mimicking polyps.
The researchers hypothesize that image quality and patient preference will vary with stool tagging concentration and dosing schedule. The researchers propose to evaluate specific stool tagging protocols with the following aims:
AIM 1: Perform a randomized trial of three specific stool tagging protocols using barium and iodine at CT colonography in a well-characterized cohort of patients undergoing colorectal evaluation.
AIM 2: Analyze the CT colonography and optical colonoscopy data to assess differences across stool tagging protocols for the outcome measures of patient preference, image quality in the presence of tagging, and diagnostic reader performance.
The researchers will use specific variations in stool tagging techniques to determine the best image quality of CT data (e.g., homogenous tagging of fluid and stool), and highest patient acceptability, as well as evaluate the adequacy of preparation for same-day colonoscopy. Diagnostic reader performance will focus on the accuracy for detecting all neoplastic lesions including colon cancers, adenomatous polyps, sessile adenomas and flat adenomas. Most importantly, these results will help inform the design of a larger trial of an optimized CT colonography technique in a community setting.
Detailed description
CT Colonography, a rapidly evolving technique, offers a noninvasive and efficient colorectal screening examination, with the potential to improve patient compliance. However, currently it requires the bowel preparation, one of the largest barriers to colonoscopy screening. A promising new tool in CT Colonography is stool tagging, which has the potential to decrease the amount of catharsis required by patients during the bowel preparation, while decreasing the number of false positives due to the reader mistaking residual stool for polyps.
Our primary hypothesis is that image quality and patient compliance differ depending upon the tagging agent and dosing schedule. Our strategy is to vary key components of recently reported barium and iodine protocols to further optimize them and to compare our results with existing and currently aggregating data in collaboration with other investigators.
The following aims will implement this strategy:
AIM 1: Perform a randomized control trial of specific stool tagging protocols at CT Colonography in a well characterized cohort of patients undergoing colorectal evaluation.
Task 1A - Recruit a prospective cohort of 60 subjects, randomize them equally to three different stool tagging protocols, and sequentially perform CT Colonography and optical colonoscopy on them.
Task 1B - Assess image quality of CT Colonography and optical colonoscopy data by the method of bowel preparation in the first five subjects of each arm and implement specific changes, if necessary.
AIM 2: Analyze the CT Colonography and optical colonoscopy data to assess differences across study arms for the outcome measures of patient preference, image quality of tagged stool, and diagnostic reader performance.
Task 2A: Assess patient expectations regarding the bowel preparations, CT Colonography and colonoscopy before the procedures and their preferences after the procedures.
Task 2B: Evaluate image quality, in the presence of tagged stool and fluid, of both the CT data and the colonoscopy data.
Task 2C: Perform a multi-observer reader evaluation of diagnostic performance of CT Colonography and colonoscopy, compared to the enhanced reference standard of colonoscopy aided by segmental unblinding of CT results, to assess sensitivity and specificity of colorectal polyp detection.
Upon completion, the three specific variations in stool tagging techniques will be compared on homogenous density of tagging and patient acceptability to determine which protocol optimizes the trade-off. Diagnostic performance of CT and colonoscopy will be compared to the enhanced reference standard of colonoscopy aided by the segmental unblinding of CT results. Most significantly, these results may help determine an optimal tagging protocol to use for larger trials of CT Colonography implementation in community settings.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are 45 to 80 years old for routine screening colonoscopy
Key exclusion criteria (7 listed)
- Patients with inflammatory bowel disease
- Patients with polyposis syndromes
- Pregnant women
- Patients over 350 pounds
- Patients with bright red blood per rectum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging procedure of CT colonography | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2006.
- Background: PubMed 14657426Pickhardt PJ, Choi JR, Hwang I, Butler JA, Puckett ML, Hildebrandt HA, Wong RK, Nugent PA, Mysliwiec PA, Schindler WR. Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. N Engl J Med. 2003 Dec 4;349(23):2191-200. doi: 10.1056/NEJMoa031618. Epub 2003 Dec 1.
- Background: PubMed 15520999Iannaccone R, Laghi A, Catalano C, Mangiapane F, Lamazza A, Schillaci A, Sinibaldi G, Murakami T, Sammartino P, Hori M, Piacentini F, Nofroni I, Stipa V, Passariello R. Computed tomographic colonography without cathartic preparation for the detection of colorectal polyps. Gastroenterology. 2004 Nov;127(5):1300-11. doi: 10.1053/j.gastro.2004.08.025.
- Background: PubMed 12147834Lefere PA, Gryspeerdt SS, Dewyspelaere J, Baekelandt M, Van Holsbeeck BG. Dietary fecal tagging as a cleansing method before CT colonography: initial results polyp detection and patient acceptance. Radiology. 2002 Aug;224(2):393-403. doi: 10.1148/radiol.2241011222.
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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.
Elizabeth G. McFarland, MD principal investigator
St. Luke's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Polyps, run by Center for Diagnostic Imaging at 1 site 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth G. McFarland, MD (636-733-8911, McFarlandB@mir.wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00124163, which also lists 3 linked publications.
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 2 Feb 2006.