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Fludeoxyglucose F 18-PET Imaging for Early Detection of Residual Disease in Patients Undergoing Radiofrequency Ablation of Liver Metastases From Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00499395
Recruitment Status : Completed
First Posted : July 11, 2007
Last Update Posted : April 3, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief Summary:

RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18-PET imaging, may be effective in detecting residual disease after radiofrequency ablation of liver metastases in patients with colorectal cancer.

PURPOSE: This clinical trial is studying fludeoxyglucose F 18-PET imaging to see how well it works for early detection of residual disease in patients undergoing radiofrequency ablation of liver metastases from colorectal cancer.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Cancer Procedure: positron emission tomography Procedure: radiofrequency ablation Not Applicable

Detailed Description:

OBJECTIVES:

Primary

  • Determine the sensitivity and specificity of fludeoxyglucose F 18 (FDG)-PET imaging in detecting residual disease within 48 hours after radiofrequency ablation (RFA) of liver metastases in patients with colorectal cancer.

Secondary

  • Determine the findings on day 7 after RFA using FDG-PET imaging in these patients.

OUTLINE: This is a prospective study.

Patients undergo fludeoxyglucose F 18 (FDG)-PET imaging at baseline. They then undergo percutaneous laparoscopic or intraoperative radiofrequency ablation (RFA). Patients then undergo further FDG-PET scans within 48 hours and 7 days after RFA. FDG-PET images are evaluated for residual disease, including focal FDG uptake at the site of ablation. Beginning 1 month after RFA, patients undergo contrast-enhanced MRI for routine post-ablation follow-up. MRI scans are performed at 1, 4, 7, 12, 18, and 24 months after completion of RFA.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Detection of Residual Colorectal Liver Metastases Within 24 Hours After RFA With 18-F FDG PET
Study Start Date : July 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: positron emission tomography
    All patients will undergo pre RFA PET prior to ablation for intra and extrahepatic staging and to assess FDG avidity of the lesions. When evaluating patients with liver metastases, we routinely obtain a dedicated liver PET study (Liver View) after the whole body PET. Patients will undergo two post RFA PET scans as part of this project: PET # 1) within 32 hours after RFA. The patients having percutaneous RFA will undergo PET on the same day after the clinical studies at the PET facility are completed; this will be within 8 hours after RFA. In case of laparoscopic and intra-operative RFA, PET will be performed on the following day after the clinical studies are completed; this will be within 32 hours after RFA. PET # 2) on day seven after RFA
  • Procedure: radiofrequency ablation
    All patients will undergo pre RFA PET prior to ablation for intra and extrahepatic staging and to assess FDG avidity of the lesions. Patients will undergo two post RFA PET scans as part of this project: PET # 1) within 32 hours after RFA. The patients having percutaneous RFA will undergo PET on the same day after the clinical studies at the PET facility are completed; this will be within 8 hours after RFA. In case of laparoscopic and intra-operative RFA, PET will be performed on the following day after the clinical studies are completed; this will be within 32 hours after RFA. PET # 2) on day seven after RFA


Primary Outcome Measures :
  1. Sensitivity and specificity of fludeoxyglucose F 18 (FDG)-PET imaging in early diagnosis of residual disease

Secondary Outcome Measures :
  1. Findings on day 7 after RFA using FDG-PET imaging


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of colorectal cancer

    • Disease metastatic to the liver
  • Undergoing percutaneous, intraoperative or laparoscopic radiofrequency ablation for liver metastases at the University of North Carolina Gastrointestinal Oncology Clinic

PATIENT CHARACTERISTICS:

  • Not pregnant

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No chemotherapy within 7 days after RFA on study

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 ClinicalTrials.gov identifier (NCT number): NCT00499395


Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Amir H. Khandani, MD UNC Lineberger Comprehensive Cancer Center

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00499395     History of Changes
Other Study ID Numbers: LCCC 0513
CDR0000553137 ( Other Identifier: PDQ number )
First Posted: July 11, 2007    Key Record Dates
Last Update Posted: April 3, 2012
Last Verified: April 2012

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
liver metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes