Protocol Number: 99-C-0025

Title:

The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms

Number:

99-C-0025

Summary:

The Radiofrequency Interstitial Tissue Ablation (RITA) unit and the Radionics CC-1 Cosman Coagulator system, and LeVeen electrodes and RF 2000 generator of the RadioTherapeutics RF Ablation System are FDA approved devices for the treatment of soft tissue. They use a modification of the standard surgical electrocautery that uses heat to destroy tissue. They have incorporated several improvements including multi-tipped cautery needles for the treatment of a larger volume of tissue as well as thermistors built into the tips which allow for accurate control of tissue temperature. There is already a large experience with these devices for the treatment of hepatic neoplasms. This protocol is designed to allow us to gain experience using these devices as well as to evaluate the use of various imaging modalities to determine tissue responses.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Patients with either primary or metastatic liver lesions who are not candidates for surgical resection either due to tumor histology, previous surgery, concomitant medical conditions or multi-site disease.

Biopsy proven evidence of cancer.

Patients with 6 or fewer lesions and with no single lesion greater than 7 cm in maximum diameter.

Age greater than or equal to 18 years.

Patients must be willing to return to NIH for their imaging scans.

Patient must be able to sign informed consent.

Life expectancy greater than or equal to 3 months.

ECOG performance status 0-2.

Patients with extrahepatic disease in addition to their hepatic metastases are eligible and may receive systemic therapy for their extrahepatic disease.

EXCLUSION CRITERIA:

Patients who are candidates for complete surgical resection.

Pregnancy or breast-feeding. A negative pregnancy test (urine or serum) is required prior to enrollment.

Known uncontrollable serious reactions such as anaphylaxis, to the contrast agents used in this study.

Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices.

PT or PTT greater than 1.5X control (except in patients who are therapeutically anticoagulated for non-related medical conditions such as atrial fibrillation).

Platelet count less than 50,000.

Total bilirubin greater than 3.0.

Serum creatinine greater than 2.5.

Patients who weigh greater than or equal to 136 kg (weight limit for the PET scanner table).

Patients with uncontrolled glucose due to diabetes may be studied, but will be evaluated separately.

Special Instructions: Currently Not Provided

Keywords:

Thermal

Cautery

RITA

Regional

Liver

Heat

Tumor

Recruitment Keywords:

None

Conditions:

Liver Neoplasm

Investigational Drug(s):

Fluorine-18-flourodeoxyglucose (FDG)

Investigational Device(s):

None

Contacts:

CSSC
Clinical Studies Support Center/NCI
164 Rollins Avenue
2nd FLoor
Rockville, MD 20852
Phone: (888) 624-1937
Fax: (301) 881-8239

Electronic Address: ncicssc@mail.nih.gov

Citations:

Laparoscopic thermal ablation of hepatic neuroendocrine tumor metastases

Magnetic resonance mapping demonstrates benefits of VEGF-induced myocardial angiogenesis

Laparoscopic ablation of a liver adenoma by radiofrequency electrocautery

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