Utility of PET In the Pre-Operative Assessment of Patients With Hepatic Colorectal Metastases
| Tracking Information | |||||
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| First Received Date ICMJE | December 24, 2007 | ||||
| Last Updated Date | March 18, 2009 | ||||
| Start Date ICMJE | July 1998 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To assess if whole body 18F-FDG-PET enhances our ability to detect metastatic colorectal cancer restricted to liver and lung over conventional imaging such as CT and to determine the accuracy of PET in imaging extrahepatic tumors. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00588549 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To determine whether PET plays a role in altering clinical management of patients undergoing evaluation for liver resection for hepatic colorectal metastases. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ] | ||||
| 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 | Utility of PET In the Pre-Operative Assessment of Patients With Hepatic Colorectal Metastases | ||||
| Official Title ICMJE | Utility of Whole-Body 18-Fluorodeoxyglucose Positron Emission Tomography (PET) In the Pre-Operative Assessment of Patients With Hepatic Colorectal Metastases | ||||
| Brief Summary | This study aims to determine whether a test, called the PET scan, may be useful in determining if there are additional locations of cancer not otherwise detectable by other tests. The PET scan is a nuclear medicine imaging study that measures how much radioactive sugar is used by your tumor. The study will compare pictures of the cancer from the PET scan to other x-ray exams, such as a CT scan, as well as to what your doctors find at the time of surgery. If the study results show that the PET scan gives us a good idea of what is happening to the tumor, then it may be useful in deciding which patients with colorectal metastases to the liver should be operated on and what operation should be performed. Additionally, by comparing the results of PET scans with the other studies that will be performed as part of your care, we will try to determine which test best tells us which patient is most likely to benefit from surgery. |
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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 | Non-Probability Sample | ||||
| Study Population | Memorial Sloan-Kettering Cancer Center patients with colorectal cancer |
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| Condition ICMJE | Colorectal Carcinoma | ||||
| 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 | 204 | ||||
| Completion Date | March 2009 | ||||
| Primary Completion Date | March 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 | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00588549 | ||||
| Other Study ID Numbers ICMJE | 98-015 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Yuman Fong, MD, Memorial Sloan-Kettering Cancer Center | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||
| Verification Date | March 2009 | ||||
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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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