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
  Purpose

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
Colorectal Carcinoma

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 204
Study Start Date: July 1998
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Memorial Sloan-Kettering Cancer Center patients with colorectal cancer

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588549

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

Additional Information:
No publications provided

Responsible Party: Yuman Fong, MD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00588549     History of Changes
Other Study ID Numbers: 98-015
Study First Received: December 24, 2007
Last Updated: March 18, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014