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


N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Metastatic Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Amir H. Khandani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

LCCC 0513

NCT ID:

NCT00499395

Start Date:

July 2005

Completion Date:

September 2007

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • liver metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Liver Neoplasms

Name

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570