Obstructing Colorectal CancerPhase 4NCT00300547
Preoperative Assessment for Synchronous Carcinoma or Polyps With Magnetic Resonance (MR) Colonography
A Phase 4 study testing MR colonography in people with Obstructing Colorectal Cancer, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to diagnose possible synchronous carcinomas and polyps with magnetic resonance (MR) colonography in patients booked for operation because of carcinoma in the descending or sigmoid colon, where a preoperative full colonoscopy is not possible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructing Colorectal Cancer
- What is being tested?
- MR colonography
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2007to Apr 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obstructing colorectal cancer
Who cannot join
- Suspicion of IBD
- Pacemaker
- Metal in the body
- Claustrophobia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Radiology Copenhagen University Hospital Herlev
Copenhagen, DK-2730
About this study
Official title: Preoperative Assessment for Synchronous Carcinoma or Polyps With MR Colonography in Patients With Obstructing Cancer. A Prospective Study.
The purpose of this study is to diagnose possible synchronous carcinomas and polyps with magnetic resonance (MR) colonography in patients booked for operation because of carcinoma in the descending or sigmoid colon, where a preoperative full colonoscopy is not possible. Two days before colonography, patients ingest a 200 ml Barium sulfate solution four times a day, which will render fecal masses "invisible" on the following MR colonography. The study is primarily a feasibility study with altered operative strategy as a secondary end-point. Gold standard is colonoscopy and operation.
- Conditions
- Obstructing Colorectal Cancer
- Being tested
- MR colonography
- Keywords
- colorectal cancer, polyps, Virtual colonoscopy, synchronous carcinoma, MR colonography
- Medical subject headings
- Colorectal Neoplasms, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR colonographyProcedure or surgery
Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of MR colonography to diagnose possible synchronous carcinomas and polyps
Measured: 3
Secondary outcomes (1)
Altered operative strategy due to findings on MR colonography
Measured: 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2006 (estimated)
- Study startMar 2007
- Primary completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructing Colorectal 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen
- Investigators
- Michael P Achiam, MD, Principal investigator, Department of Radiology Copenhagen University Hospital Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300547
- Sponsor's protocol ID
- KA05030-MA
- Other IDs
- KA05030
- Status last verified
- Mar 2006
- First submitted
- 8 Mar 2006
- Last updated
- 18 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Assessment for Synchronous Carcinoma or Polyps With MR Colonography in Patients With Obstructing Cancer. A Prospective Study.
- ClinicalTrials.gov ID
- NCT00300547
- Acronym / sponsor ID
- KA05030-MA
- Conditions
- Obstructing Colorectal Cancer
- Keywords
- colorectal cancer, polyps, Virtual colonoscopy, synchronous carcinoma, MR colonography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen
- Study start
- Mar 2007
- Primary completion
- Apr 2008 (actual)
- First posted
- 9 Mar 2006 (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.
The purpose of this study is to diagnose possible synchronous carcinomas and polyps with magnetic resonance (MR) colonography in patients booked for operation because of carcinoma in the descending or sigmoid colon, where a preoperative full colonoscopy is not possible. Two days before colonography, patients ingest a 200 ml Barium sulfate solution four times a day, which will render fecal masses "invisible" on the following MR colonography. The study is primarily a feasibility study with altered operative strategy as a secondary end-point. Gold standard is colonoscopy and operation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obstructing colorectal cancer
Key exclusion criteria (5 listed)
- Suspicion of IBD
- Pacemaker
- Metal in the body
- Claustrophobia
- Pregnancy
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 |
|---|---|---|
| MR colonographyAltered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps | Procedure or surgery | – |
Primary outcome
Feasibility of MR colonography to diagnose possible synchronous carcinomas and polyps
Time frame: 3
1 secondary outcome
Altered operative strategy due to findings on MR colonography
Time frame: 3
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 18 Aug 2010.
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.
Michael P Achiam, MD principal investigator
Department of Radiology Copenhagen University Hospital Herlev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MR colonography in people with Obstructing Colorectal Cancer, run by Herlev Hospital at 1 site in Denmark.
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 5 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 18 Aug 2010. 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 Denmark. 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?
Feasibility of MR colonography to diagnose possible synchronous carcinomas and polyps (time frame: 3). 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 18 Aug 2010.