NCT00499395

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Colorectal Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2007-07-11
• Last updated: 2012-04-03

Locations

1 site across 1 country: United States