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

Phase 2

Terminated

Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Liver Cancer
Metastatic Cancer

Interventions: Procedure: computed tomography
Procedure: magnetic resonance imaging
Procedure: positron emission tomography
Procedure: radiofrequency ablation
Procedure: radionuclide imaging
Procedure: ultrasound imaging
Radiation: fludeoxyglucose F 18 (FDG-PET)
Radiation: gadopentetate dimeglumine

Registration Number: NCT00019604

Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief 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.

Detailed 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 computed tomography (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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiofrequency ablation in liver cancer	magnetic resonance imaging	This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Radiofrequency ablation in liver cancer	fludeoxyglucose F 18 (FDG-PET)	This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Radiofrequency ablation in liver cancer	gadopentetate dimeglumine	This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Radiofrequency ablation in liver cancer	computed tomography	This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Radiofrequency ablation in liver cancer	radionuclide imaging	This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Radiofrequency ablation in liver cancer	ultrasound imaging	This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Radiofrequency ablation in liver cancer	radiofrequency ablation	This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Radiofrequency ablation in liver cancer	positron emission tomography	This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.

Primary Outcome Measures

Name	Time	Method
Response		Standard response criteria will be used to assess the CT (computed tomography) scan images on a lesion per lesion basis. Complete response is complete disappearance of the index lesion on followup scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.

Secondary Outcome Measures

Name	Time	Method
Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Computed Tomography (CT)	Baseline, 6 weeks, 3 months, and 6 months following treatment	Participants were to undergo FDG-PET scanning and CT scans to compare changes in size of metabolically active volume and standard uptake value (tumor metabolism).
Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Biopsies	Baseline, 6 weeks, 3 months, and 6 months following treatment	Participants were to undergo tissue biopsies of tumor to quantify changes in the tumor to see if the changes we see on the imaging studies are the same as the changes in the tumor.
Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Serum Markers	Baseline, 6 weeks, 3 months, and 6 months following treatment	Images obtained by the FDG-PET was to be processed for changes in measured parameters and quantified compared to serum markers at baseline and appropriate follow-up points.
Tumor Blood Flow	Baseline, 3 months, and 6 months following treatment	Tumor blood flow was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density.
Percentage of Participants With a Response Using Fludeoxyglucose (18F) - Positron Emission Tomography (FDG-PET) Following Radiofrequency Ablation (RFA)	Baseline, 6 weeks, 3 months, and 6 months following treatment	Response was to be evaluated by the standard response criteria. Complete response is the complete disappearance of the index lesion on follow-up scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.
Compare the Performance of Fludeoxyglucose (18F) Positron-Emission Tomography to Computed Tomography and Magnetic Resonance Imaging With Respect to Their Ability to Assess the Effects of Radiofrequency Ablation on the Treatment of Hepatic Neoplasms	Baseline, 6 weeks, 3 months, and 6 months following treatment	Images obtained by the FDG-PET, MRI and CT was to be processed for changes in measured parameters and quantified compared to baseline (e.g., \<median change, \>median change in size on CT, computed by subtracting the baseline value from the value at the appropriate follow-up point).
Number of Participants With Adverse Events	9 years, 9 months	Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Tumor Vascular Density	Baseline, 3 months, and 6 months following treatment	Tumor vascular density was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density. Patterns of MRI contrast uptake within tumors correlate with microvessel density.
Evaluate the Ability of Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) to Monitor Response Following Radiofrequency Ablation (RFA)	Baseline, 6 weeks, 3 months, and 6 months following treatment	PET scan images was to be read by a physician experienced in the interpretation of whole body PET imaging. The region of interest was to be performed in any abnormal sites of uptake that is a candidate and or has been RFA ablated.