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

NCT ID: NCT00499395

Last Updated: 2012-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2007-09-30

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.

Conditions

Colorectal Cancer; Metastatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amir H. Khandani, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

CDR0000553137

Identifier Type: OTHER

Identifier Source: secondary_id

LCCC 0513

Identifier Type: -

Identifier Source: org_study_id