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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00641238
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : May 14, 2015
Information provided by (Responsible Party):
Ernest Scalzetti, State University of New York - Upstate Medical University

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

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer (NSCLC) Device: Radiofrequency ablation

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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Follow-up of Patients Treated With Radiofrequency Ablation of Lung Masses.
Study Start Date : March 2004
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Early stage NSCLC
Early stage non-small cell lung cancer
Device: Radiofrequency ablation
Radiofrequency ablation

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 years after diagnosis of NSCLC ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with clinical stage I NSCLC that are treated with Radiofrequency ablation.

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00641238

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United States, New York
Upstate Medical University
Syracuse, New York, United States, 13201
Sponsors and Collaborators
State University of New York - Upstate Medical University
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Principal Investigator: Ernest Scalzetti, MD State University of New York - Upstate Medical University
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Responsible Party: Ernest Scalzetti, MD, State University of New York - Upstate Medical University Identifier: NCT00641238    
Other Study ID Numbers: SUNYUMU 4886
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2015
Keywords provided by Ernest Scalzetti, State University of New York - Upstate Medical University:
lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms