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Utility of PET In the Pre-Operative Assessment of Patients With Hepatic Colorectal Metastases

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00588549
First received: December 24, 2007
Last updated: March 18, 2009
Last verified: March 2009

December 24, 2007
March 18, 2009
July 1998
March 2009   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00588549 on ClinicalTrials.gov Archive Site
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 ]
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Utility of PET In the Pre-Operative Assessment of Patients With Hepatic Colorectal Metastases
Utility of Whole-Body 18-Fluorodeoxyglucose Positron Emission Tomography (PET) In the Pre-Operative Assessment of Patients With Hepatic Colorectal Metastases

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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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Memorial Sloan-Kettering Cancer Center patients with colorectal cancer

Colorectal Carcinoma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • initial diagnosis of colorectal carcinoma confirmed by the Pathology Department of Memorial Hospital or by diagnostic barium enema if the primary tumor is still in place.
  • a candidate for liver resection for metastatic colorectal cancer as defined by members of the Department of Surgery of Memorial Hospital. Patients with metastatic colorectal cancer isolated to the colon, rectum, or liver are eligible. In addition, patients with limited, resectable pulmonary metastases are eligible.

Exclusion Criteria:

  • Patients must not be pregnant; females of child bearing age must use an adequate form of contraception.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00588549
98-015
No
Yuman Fong, MD, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Yuman Fong, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP