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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00588549
Recruitment Status : Completed
First Posted : January 8, 2008
Last Update Posted : March 19, 2009
Information provided by:
Memorial Sloan Kettering Cancer Center

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.

Condition or disease
Colorectal Carcinoma

Study Type : Observational
Actual Enrollment : 204 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utility of Whole-Body 18-Fluorodeoxyglucose Positron Emission Tomography (PET) In the Pre-Operative Assessment of Patients With Hepatic Colorectal Metastases
Study Start Date : July 1998
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Memorial Sloan-Kettering Cancer Center patients with colorectal cancer

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00588549

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Principal Investigator: Yuman Fong, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Yuman Fong, MD, Memorial Sloan-Kettering Cancer Center Identifier: NCT00588549     History of Changes
Other Study ID Numbers: 98-015
First Posted: January 8, 2008    Key Record Dates
Last Update Posted: March 19, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases