CLINICAL TRIAL: 11546 ACRIN 6678--FDG-PET/CT as a Predictive Marker of Tumor Response and Patient Outcome: Prospective Validation in Non-small Cell Lung Cancer Principal Investigator: Alan Waxman, M.D. Status: Active and Recruiting Disease: Non Small Cell Lung Cancer Summary: The purpose of this research study is to determine if FDG-PET/CT scans can help doctors determine if chemotherapy is effectively controlling non-small cell lung cancer. This will also test the hypothesis that FDG-PET/CT may be an early predictor of disease progression or regression.
22286 A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma Principal Investigator: Marc L. Friedman, M.D Status: Active Disease: Unresectable Hepatocellular (Liver) Cancer Summary: Therasphere® is microscopic glass beads embedded with Yttrium-90, a form of high-energy radiation used to treat cancers, in this case, liver cancer that cannot be surgically removed. It is also used as neoadjuvant therapy to shrink the liver tumor before liver surgery or transplant.
A Humanitarian Use Device (HUD) is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the United States per year. They are FDA approved to incentivize the development of devices for diseases affecting small populations because of high development costs. Treatment under the HDE Treatment Protocol is not investigational, not part of a clinical trial but does permit ongoing investigation of the clinical outcomes of the HUD according to institutional practices, monitored by the IRB.
17796 18F-Fluoride PET/CT versus 99m-Tc-MDP Scanning for Detecting Bone Metastases: A Randomized, Multi-Center Trial to Compare Two Bone Imaging Techniques Principal Investigator: Alan D. Waxman, M.D. Status: Active and Recruiting Disease: Cancer with Bone Metastasis Summary: The purpose of this research study is to compare the accuracy of Sodium Fluoride 18F-NaF (a skeletal imaging PET tracer) for PET combined CT (computer tomography) scanning to the standard of care 99mTc-MDP (Technetium-99m methylene disphosphonate) bone scanning for detecting cancer that has spread to the bone.