Preoperative Assessment of Colon Tumor
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by Herlev Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Herlev Hospital
Collaborator:
University Hospital, Gentofte, Copenhagen
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00114829
First received: June 17, 2005
Last updated: March 8, 2006
Last verified: May 2005
| Tracking Information | |||||
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| First Received Date ICMJE | June 17, 2005 | ||||
| Last Updated Date | March 8, 2006 | ||||
| Start Date ICMJE | July 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Sensitivity in determining malignant or benign diagnose | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00114829 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Sensitivity/specificity of MR colonography | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Preoperative Assessment of Colon Tumor | ||||
| Official Title ICMJE | Preoperative Assessment of Colon Tumor: A Prospective, Blinded Study. | ||||
| Brief Summary | The purpose of this study is to determine whether a colonic tumor can be classified as malignant or benign with magnetic resonance (MR) colonography. Patients with a verified colon carcinoma or benign tumor based on diverticulitis are offered a MR colonography with intravenous (I.V.) contrast. The tumor is classified as malignant or benign by assessing the dynamic contrast uptake and morphology. The Investigator is blinded from the verified diagnosis and the MR classification is compared to the histological diagnosis. |
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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: Double-Blind Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: MR colonography with dynamic contrast uptake | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Achiam MP, Andersen LP, Klein M, Løgager V, Chabanova E, Thomsen HS, Rosenberg J. Differentiation between benign and malignant colon tumors using fast dynamic gadolinium-enhanced MR colonography; a feasibility study. Eur J Radiol. 2010 Jun;74(3):e45-50. Epub 2009 May 5. | ||||
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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 | Recruiting | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00114829 | ||||
| Other Study ID Numbers ICMJE | KA05028-MA, KA05028 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Herlev Hospital | ||||
| Collaborators ICMJE | University Hospital, Gentofte, Copenhagen | ||||
| Investigators ICMJE |
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| Information Provided By | Herlev Hospital | ||||
| Verification Date | May 2005 | ||||
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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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