Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499395
Status:
COMPLETED
Last Update Posted:
2012-04-03
First Post:
2007-07-10
Brief Title:
Fludeoxyglucose F 18-PET Imaging for Early Detection of Residual Disease in Patients Undergoing Radiofrequency Ablation of Liver Metastases From Colorectal Cancer
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Detection of Residual Colorectal Liver Metastases Within 24 Hours After RFA With 18-F FDG PET
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000553137 | OTHER | PDQ number | None |