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

Purpose

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.

Condition	Intervention
Colorectal Cancer Metastatic Cancer	Drug: fludeoxyglucose F 18 Procedure: positron emission tomography Procedure: radiofrequency ablation

MedlinePlus related topics:

Cancer Colorectal Cancer

ChemIDplus related topics:

Fluorodeoxyglucose F18

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic

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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Sensitivity and specificity of fludeoxyglucose F 18 (FDG)-PET imaging in early diagnosis of residual disease [ Designated as safety issue: No ]

Secondary Outcome Measures:

Findings on day 7 after RFA using FDG-PET imaging [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	May 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499395

Locations


United States, North Carolina
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
	Chapel Hill, North Carolina, United States, 27599-7295

Sponsors and Collaborators

UNC Lineberger Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Amir H. Khandani, MD	UNC Lineberger Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000553137, UNC-LCCC-0513
First Received:	July 10, 2007
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00499395
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV colon cancer

stage IV rectal cancer

recurrent colon cancer

recurrent rectal cancer

liver metastases

Study placed in the following topic categories:

Digestive System Diseases

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Neoplasm Metastasis

Gastrointestinal Neoplasms

Intestinal Diseases

Rectal cancer

Rectal Diseases

Intestinal Neoplasms

Recurrence

Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplastic Processes

Neoplasms

Pathologic Processes

Neoplasms by Site

ClinicalTrials.gov processed this record on October 06, 2008

Sponsors and Collaborators:	UNC Lineberger Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00499395