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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Detection of Residual Colorectal Liver Metastases Within 24 Hours After RFA With 18-F FDG PET

Conditions
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Colorectal Cancer, Metastatic Cancer

Intervention / Treatment
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* Procedure: positron emission tomography
* Procedure: radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of fludeoxyglucose F 18 (FDG)-PET imaging in early diagnosis of residual disease |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Findings on day 7 after RFA using FDG-PET imaging |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, liver metastases