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OPENING DAY ON THE BAY 2012 SKIN
For the needle biopsy, a needle is inserted through the skin and guided by CT into the tumor mass. The tumor biopsy is done either using a small bore needle under CT guidance or by direct visualization using a laparoscope/thoracoscope. A biopsy is the surgical removal of a small piece of tissue.
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For the test, the patient is given an injection of a sugar solution in which a radioactive tracer has been attached to the sugar molecule. Because rapidly growing cells, such as tumors, use more sugar than normal cells do, this test can be used to detect cancer. PET-CT approximately every 8 weeks to look at how different parts of the body take up and use glucose (a sugar nutrient).MRI uses a powerful magnet and radio waves instead of x-rays to produce accurate, detailed pictures of organs and tissues. It can be done from different angles, providing a 3-dimensional picture of the part of the body being studied and allowing the doctor to see the location, nature, and extent of disease. CT is an x-ray test that provides detailed pictures of the inside of the body. CT scans or other imaging tests, such as ultrasound or MRI, every 8 weeks to evaluate the tumor's response to treatment.Blood pressure checks once a week during the first 4 weeks.In addition to drug therapy, patients undergo the following tests and procedures: Treatment with BAY 43-9006 continues until the study doctor determines that the medication is not beneficial or the patient wishes to withdraw from the study. For the test, blood is collected at intervals (at 15 minutes, 30 minutes, and 1, 2, 4, 6, 8, 12 and 24 hours after ingestion) to determine the drug's level in the bloodstream. On the first and 15th days of treatment, patients are admitted to the hospital for pharmacokinetic studies that is, a test of how the body handles the drug. Participants take BAY 43-9006 by mouth twice a day, morning and evening. Candidates are screened with a medical history and physical examination blood tests tumor biopsy (see below) chest x-ray electrocardiogram and imaging studies, including positron emission tomography-computed tomography (PET-CT, see below) and dynamic, contrast-enhanced MRI (DCE-MRI, see below). Patients 18 years of age and older with NSCLC that has recurred or progressed after one regimen of chemotherapy may be eligible for this study.
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BAY 43-9006 is one of a new class of anticancer agents known as bi-aryl ureas. This study will investigate the effects and side effects of BAY 43-9006 in patients with advanced, recurrent, or refractory non-small cell lung cancer (NSCLC). Why Should I Register and Submit Results?.