Patients With Potential Colorectal NeoplasiaPhase 4NCT00212433
Optimisation and Performance of Reduced Preparation CT Colography
A Phase 4 study testing Tagitol V, Lo So, Readi-Cat 2 in people with Patients With Potential Colorectal Neoplasia, run by London North West Healthcare NHS Trust at 3 sites in United Kingdom.
Trial summary
To ascertain which of four combinations of low residue diet, reduced laxative dose and oral contrast agent is best tolerated by patients and optimally prepares the colon prior ro CT colonography Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Patients With Potential Colorectal Neoplasia
- What is being tested?
- Tagitol V, Lo So, Readi-Cat 2
- How many people
- 120 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jul 2004to Feb 2006
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are under investigation for suspected colonic neoplasia and over 50 years old:
- Symptomatic patients eg. change in bowel habit, rectal bleeding etc.
- Polyp surveillance
- Strong family history
- suspected neoplasia on previous investigation (e.g. barium enema)
Who cannot join
- patients under 50 patients undergoing surveillance for inflammatory bowel disease (due to poor diagnostic use of CT colonography in this specific patient cohort)
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
St Mark's Hospital, North West London Hospitals NHS Trust
London, Middlesex, HA1 3UJ
University College Hospital
London, NW1 2BU
Oxford Radcliffe Hospital NHS Trust
Oxford
About this study
Official title: Multidetector-row CT Colonography: Optimisation of Reduced Bowel Preparation Regimes and Diagnostic Performance in Comparison to Colonoscopy
To ascertain which of four combinations of low residue diet, reduced laxative dose and oral contrast agent is best tolerated by patients and optimally prepares the colon prior ro CT colonography
Read the detailed description
CT colonography has been shown to be accurate in detection of colorectal neoplasia in enriched patient populations and is generally preferred by patients to conventional endoscopy and barium enema. It is advocated as an acceptable alternative for colorectal cancer screening and is increasingly used in the investigation of symptomatic patients. Ideally, like conventional colonoscopy, CT colonography requires a clean colon, free of residual stool and fluid. There is however good evidence that the arduous bowel purgation regimes required may produce adverse effects such as electrolyte imbalance, and are more detrimental to overall patient experience and compliance than any subsequent investigation. An ability to perform CT colonography with reduced bowel purgation, whilst maintaining acceptable diagnostic accuracy, would undoubtedly make the technique a more attractive proposition both for population screening and investigation of symptomatic patients.
Interest has been generated in the use of orally ingested dilute barium or ionated contrast medium prior ro CT colonography to "label" or "tag" residual fluid or faecal matter reduced laxative. Such oral contrast agents are highly attenuating to X-rays such that labeled residual bowel contents appear white on CT scanning and are readily distinguished from true colonic pathology.
Despite the early promise of a few limited studies, there is no consensus as to the optimum oral contrast type, dose and concentration. Anecdotally barium tends to best label solid residue whereas iodinated contrast best labels fluid, but this assumption has not been proven. Furthermore it is known that iodinated contrast tends to draw fluid into the bowel, producing a wet colon, which may not be suited to CT colonography. However, this indrawing of fluid by iodinated contrast such as gastrograffin produces a mild laxative effect, which may obviate the need for further formal purgation.
The study aims to establish the optimum reduced preparation-tagging regimen, establish patient experience and document diagnostic performance compared to conventional colonoscopy.
- Being tested
- Tagitol V, Lo So, Readi-Cat 2
- Keywords
- colorectal neoplasia, CT colonography, faecal tagging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tagitol V, Lo So, Readi-Cat 2Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Which of four combinations of low residue diet, reduced laxative dose and oral contrast agent is best tolerated by patients and optimally prepares the colon prior ro CT colonography
Secondary outcomes (1)
to compare the diagnostic performance of CT colonography after reduced bowel preparation and faecal tagging with conventional colonoscopy in patients undergoing both procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJul 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Potential Colorectal NeoplasiaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- St Mark's Foundation
- Investigators
- Stuart Taylor, MD, Principal investigator, St Mark's Hospital, North West London NHS Trust; & University College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212433
- Sponsor's protocol ID
- 04/Q0405/CT2
- Status last verified
- May 2025
- First submitted
- 12 Sep 2005
- Last updated
- 23 May 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidetector-row CT Colonography: Optimisation of Reduced Bowel Preparation Regimes and Diagnostic Performance in Comparison to Colonoscopy
- ClinicalTrials.gov ID
- NCT00212433
- Acronym / sponsor ID
- 04/Q0405/CT2
- Keywords
- colorectal neoplasia, CT colonography, faecal tagging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- St Mark's Foundation
- Study start
- Jul 2004
- Study completion
- Feb 2006
- First posted
- 21 Sep 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.
To ascertain which of four combinations of low residue diet, reduced laxative dose and oral contrast agent is best tolerated by patients and optimally prepares the colon prior ro CT colonography
Detailed description
CT colonography has been shown to be accurate in detection of colorectal neoplasia in enriched patient populations and is generally preferred by patients to conventional endoscopy and barium enema. It is advocated as an acceptable alternative for colorectal cancer screening and is increasingly used in the investigation of symptomatic patients. Ideally, like conventional colonoscopy, CT colonography requires a clean colon, free of residual stool and fluid. There is however good evidence that the arduous bowel purgation regimes required may produce adverse effects such as electrolyte imbalance, and are more detrimental to overall patient experience and compliance than any subsequent investigation. An ability to perform CT colonography with reduced bowel purgation, whilst maintaining acceptable diagnostic accuracy, would undoubtedly make the technique a more attractive proposition both for population screening and investigation of symptomatic patients.
Interest has been generated in the use of orally ingested dilute barium or ionated contrast medium prior ro CT colonography to "label" or "tag" residual fluid or faecal matter reduced laxative. Such oral contrast agents are highly attenuating to X-rays such that labeled residual bowel contents appear white on CT scanning and are readily distinguished from true colonic pathology.
Despite the early promise of a few limited studies, there is no consensus as to the optimum oral contrast type, dose and concentration. Anecdotally barium tends to best label solid residue whereas iodinated contrast best labels fluid, but this assumption has not been proven. Furthermore it is known that iodinated contrast tends to draw fluid into the bowel, producing a wet colon, which may not be suited to CT colonography. However, this indrawing of fluid by iodinated contrast such as gastrograffin produces a mild laxative effect, which may obviate the need for further formal purgation.
The study aims to establish the optimum reduced preparation-tagging regimen, establish patient experience and document diagnostic performance compared to conventional colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are under investigation for suspected colonic neoplasia and over 50 years old:
Key exclusion criteria (1 listed)
- patients under 50 patients undergoing surveillance for inflammatory bowel disease (due to poor diagnostic use of CT colonography in this specific patient cohort)
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 |
|---|---|---|
| Tagitol V, Lo So, Readi-Cat 2 | Drug | – |
Primary outcome
Which of four combinations of low residue diet, reduced laxative dose and oral contrast agent is best tolerated by patients and optimally prepares the colon prior ro CT colonography
1 secondary outcome
to compare the diagnostic performance of CT colonography after reduced bowel preparation and faecal tagging with conventional colonoscopy in patients undergoing both procedures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
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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.
Stuart Taylor, MD principal investigator
St Mark's Hospital, North West London NHS Trust; & University College Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tagitol V, Lo So, Readi-Cat 2 in people with Patients With Potential Colorectal Neoplasia, run by London North West Healthcare NHS Trust at 3 sites in United Kingdom.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Which of four combinations of low residue diet, reduced laxative dose and oral contrast agent is best tolerated by patients and optimally prepares the colon prior ro CT colonography. 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 23 May 2025.