Preoperative Assessment for Synchronous Carcinoma or Polyps With Magnetic Resonance (MR) Colonography
This study has been completed.
Sponsor:
Herlev Hospital
Collaborator:
University Hospital, Gentofte, Copenhagen
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00300547
First received: March 8, 2006
Last updated: August 17, 2010
Last verified: March 2006
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 8, 2006 | ||||
| Last Updated Date | August 17, 2010 | ||||
| Start Date ICMJE | March 2007 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Feasibility of MR colonography to diagnose possible synchronous carcinomas and polyps [ Time Frame: 3 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Feasibility of MR colonography to diagnose possible synchronous carcinomas and polyps | ||||
| Change History | Complete list of historical versions of study NCT00300547 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Altered operative strategy due to findings on MR colonography [ Time Frame: 3 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Altered operative strategy due to findings on MR colonography | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Preoperative Assessment for Synchronous Carcinoma or Polyps With Magnetic Resonance (MR) Colonography | ||||
| Official Title ICMJE | Preoperative Assessment for Synchronous Carcinoma or Polyps With MR Colonography in Patients With Obstructing Cancer. A Prospective Study. | ||||
| Brief 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. 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Obstructing Colorectal Cancer | ||||
| Intervention ICMJE | Procedure: MR colonography
Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 50 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00300547 | ||||
| Other Study ID Numbers ICMJE | KA05030-MA, KA05030 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Michael Achiam, MD, Herlev Hospital | ||||
| Study Sponsor ICMJE | Herlev Hospital | ||||
| Collaborators ICMJE | University Hospital, Gentofte, Copenhagen | ||||
| Investigators ICMJE |
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| Information Provided By | Herlev Hospital | ||||
| Verification Date | March 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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