Outcome of Patients With Lung Masses Who Are Treated With Radiofrequency Ablation (RFA)

NCT ID: NCT00641238

Last Updated: 2023-12-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2011-02-28

Brief Summary

We are collecting clinical notes and results of imaging studies (CT and PET scans) from referring physicians who follow the clinical status of patients treated with radiofrequency ablation (RFA). The research objective is to determine whether the patients with (RFA) remain alive, and whether they are in remission or have progressive/ recurrent malignancy

Detailed Description

Radiofrequency ablation (RFA) is a relatively new treatment for localized forms of cancer. It requires that a device called a needle-electrode be placed in the tumor. Radiofrequency energy can be passed through this needle-electrode that heats the tissue surrounding the needle tip. If the heating effect is intense enough and maintained for a long enough period of time, the cells in the treated area will be destroyed. RFA has been used in the lung to treat metastases from cancers originating in other sites, and cancers other than small cell carcinoma (Non-small cell lung cancer, NSCLC) that arise in the lung itself.

Pre-treatment assessment includes evaluation of the patient and the tumor itself; this determines whether the patient meets the entry criteria. These criteria are:

• Patient has a biopsy-proven NSCLC, with no other sites of disease, and with a tumor small enough to treat (usually <4 cm). Clinical stage I NSCLC.
• Patient is not a candidate for surgical removal of the cancer, or refused surgery.
• Patient is not a candidate for radiation therapy, or refused radiation therapy.
• Patient has > 6 month life expectancy. The procedure is performed similar to a needle biopsy of the lung, under CT guidance. Placement of the needle-electrode is similar to needle placement for CT-guided biopsy. Appropriate positioning of the needle-electrode is confirmed by CT imaging. Radiofrequency energy is applied to the needle-electrode and the tissue is monitored continuously for electrical changes that indicate tissue destruction. After completion of the treatment, the needle-electrode is removed. The patient is followed for at least three hours prior to discharge. Complications that can be discovered at this time are pulmonary hemorrhage (bleeding in the lung) and pneumothorax (leakage of air from the lung at the site of needle puncture). Subsequent follow-up usually consists of a CT scan at three months and six months after the RFA, and then at six month intervals after that, to see whether the tumor successfully has been transformed into a scar, or continues to grow.

This follow-up is conducted by the referring physician, who may not be associated with this institution. We gather and record this follow-up information until the patient dies, has documented recurrence of the cancer, or completes five years of post- treatment observation. In the cases of recurrence, we also determine whether the tumor is re-growing at the treatment site, or at distant sites that appeared to be uninvolved at the time of treatment.

Statistical analysis will be performed using de-identified patient data. Measures of interest include lifetable determination of median survival and 5-year overall survival. Patients will undergo no study-related procedures during the follow-up period. Chemotherapy given at any time following RFA, at the discretion of a medical oncologist, will not result in exclusion of the patient from analysis.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

NSCLC; lung cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Early stage NSCLC

Early stage non-small cell lung cancer

Radiofrequency ablation

Intervention Type: DEVICE

Radiofrequency ablation

Interventions

Radiofrequency ablation

Radiofrequency ablation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with lung masses
• Patients who consent to radiofrequency ablation of mass

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ernest Scalzetti

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ernest Scalzetti, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

Upstate Medical University

Syracuse, New York, United States

Countries

United States

Other Identifiers

SUNYUMU 4886

Identifier Type: -

Identifier Source: org_study_id