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Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer

2014-08-27 03:56:47 | BioPortfolio

Summary

RATIONALE: Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have unresectable primary or metastatic liver cancer.

Description

OBJECTIVES:

- Evaluate the nature and duration of response of patients with primary or metastatic liver neoplasms, who are not candidates for surgical resection, treated with radiofrequency interstitial tissue ablation.

- Evaluate the ability of dynamic magnetic resonance imaging (MRI) to assess the effects of this therapy on tumor blood flow and tumor vascular density in these patients.

- Determine the ability of positron emission tomography with fludeoxyglucose F 18 (FDG-PET) to monitor response after treatment with this therapy in these patients.

- Compare FDG-PET results with CT scan, biopsy, and serum marker results in patients treated with this therapy.

- Compare the performance of FDG-PET with CT scan and MRI, in terms of their ability to assess the efficacy of this therapy in these patients.

OUTLINE: Lesions are targeted by ultrasound and then radiofrequency ablation needles are inserted into the lesions and heated to a target temperature greater than 60 degrees C for 15 minutes, though exposure time may vary depending on temperatures achieved. To achieve a 1 cm margin of ablated tissue around each lesion, multiple ablation courses may be performed, depending on the size of the lesions and the time required to complete the treatment.

Patients undergo magnetic resonance imaging with gadopentetate dimeglumine contrast, CT scan, ultrasound, and positron emission tomography with fludeoxyglucose F 18 at baseline, 6 weeks, every 3 months for 1 year, and then every 6 months for 2 years.

Patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months for 2 years or until evidence of recurrence.

PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study within 6 years.

Study Design

Primary Purpose: Treatment

Conditions

Liver Cancer

Intervention

computed tomography, magnetic resonance imaging, positron emission tomography, radiofrequency ablation, radionuclide imaging, ultrasound imaging, fludeoxyglucose F 18, gadopentetate dimeglumine

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda
Maryland
United States
20892-1182

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:47-0400

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Medical and Biotech [MESH] Definitions

An imaging technique that combines a POSITRON-EMISSION TOMOGRAPHY (PET) scanner and a CT X RAY scanner. This establishes a precise anatomic localization in the same session.

An imaging technique using compounds labelled with short-lived positron-emitting radionuclides (such as carbon-11, nitrogen-13, oxygen-15 and fluorine-18) to measure cell metabolism. It has been useful in study of soft tissues such as CANCER; CARDIOVASCULAR SYSTEM; and brain. SINGLE-PHOTON EMISSION-COMPUTED TOMOGRAPHY is closely related to positron emission tomography, but uses isotopes with longer half-lives and resolution is lower.

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Descriptive anatomy based on three-dimensional imaging (IMAGING, THREE-DIMENSIONAL) of the body, organs, and structures using a series of computer multiplane sections, displayed by transverse, coronal, and sagittal analyses. It is essential to accurate interpretation by the radiologist of such techniques as ultrasonic diagnosis, MAGNETIC RESONANCE IMAGING, and computed tomography (TOMOGRAPHY, X-RAY COMPUTED). (From Lane & Sharfaei, Modern Sectional Anatomy, 1992, Preface)

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