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

Not Applicable

Completed

• Conditions: Colorectal Cancer; Metastatic Cancer

• Registration Number: NCT00499395
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-07
• Study First Submitted: 2007-07-10
• Study First Submitted QC: 2007-07-10
• Study First Posted: 2007-07-11
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-02
• Last Update Posted: 2012-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of fludeoxyglucose F 18 (FDG)-PET imaging in early diagnosis of residual disease

Secondary Outcome Measures

Name	Time	Method
Findings on day 7 after RFA using FDG-PET imaging

Trial Locations

Locations (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States