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

National Institutes of Health Clinical Center (CC)

Status and phase: Terminated; Phase 2

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

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

Study type: Interventional

Funder types: NIH

Identifiers

NCT00019604

CDR0000066875

990025

99-C-0025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary or metastatic liver lesions

  • Not a candidate for surgical resection

• Must have six or fewer lesions and no single lesion greater than 7 cm in diameter

• Extrahepatic disease allowed

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Platelet count at least 50,000/mm^3
• Prothrombin time (PT) or partial thromboplastin time (PTT) no greater than 1.5 times control (except for therapeutically anticoagulated nonrelated medical conditions [e.g., atrial fibrillation])

Hepatic:

• Bilirubin no greater than 3.0 mg/dL

Renal:

• Creatinine no greater than 2.5 mg/dL

Other:

• Not pregnant or nursing
• Negative pregnancy test
• No pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices
• No known uncontrollable serious reactions (e.g., anaphylaxis) to contrast agents used in this study
• Weight less than 136 kg

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• Concurrent systemic therapy for extrahepatic disease is allowed only if begun prior to radiofrequency ablation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Radiofrequency ablation in liver cancer

Experimental group

Description:

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.

Treatment:

Procedure: magnetic resonance imaging

Radiation: gadopentetate dimeglumine

Procedure: computed tomography

Procedure: ultrasound imaging

Procedure: radiofrequency ablation

Procedure: radionuclide imaging

Radiation: fludeoxyglucose F 18 (FDG-PET)

Procedure: positron emission tomography