Image Fusion PET, CT and 3D-ultrasound Examinations
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 10, 2006 | ||||||||
| Last Updated Date | November 29, 2012 | ||||||||
| Start Date ICMJE | June 2006 | ||||||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Program to fuse 3D ultrasound and PET/CT data [ Time Frame: april 2009 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00302094 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Image Fusion PET, CT and 3D-ultrasound Examinations | ||||||||
| Official Title ICMJE | Image Fusion PET, CT and 3D-ultrasound Examinations in Treatment of Anal Cancer | ||||||||
| Brief Summary | CT-examinations are used in computer programs which are used in the planning of external radiation of cancers in the anal canal. In CT the structures of the anal canal are hardly visible. 3D-ultrasound examinations offer a better visualisation of normal and pathological structures of the anal canal. The description of the tumour made from the 3D-ultrasound examination is used in the planning of the external radiation. PET-CT is used to visualise tumour activity also in lymp nodes. The hypothesis of the study is that image fusion of PET, CT and 3D-ultrasound will offer better visualisation of tumour and hereby more accurate diagnostics and treatment. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Patients with anal cancer |
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| Condition ICMJE | Anal Cancer | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (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 | 10 | ||||||||
| Completion Date | April 2009 | ||||||||
| Primary Completion Date | April 2009 (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 | NCT00302094 | ||||||||
| Other Study ID Numbers ICMJE | (KF) 11-107/03 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Caroline Ewertsen, Rigshospitalet, Denmark | ||||||||
| Study Sponsor ICMJE | Rigshospitalet, Denmark | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Rigshospitalet, Denmark | ||||||||
| Verification Date | November 2012 | ||||||||
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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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