This trial studies how well fluorine-18-labeled fluoro-misonidazole (18F-FMISO) breath-hold positron emission tomography (PET)/computed tomography (CT) works in measuring tumor hypoxia (decrease in oxygen supply) in patients with non-small cell lung cancer who are receiving treatment. PET/CT uses a radioactive label, a "tracer" called 18F-FMISO, which can recognize tumor cells that have a low level of oxygen to take detailed pictures of areas inside the body. Due to patient breathing, imaging may become susceptible to breathing-induced uncertainties. Breath-hold PET/CT may improve the accuracy of PET quantitation. Comparing results of diagnostic procedures done before and during treatment may help doctors predict a patient's response to treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02016872.
PRIMARY OBJECTIVES:
I. To correlate the presence and extent of hypoxia, as defined by 18F-FMISO Free-Breathing (FB) and Breath-Hold (BH) PET/CT at baseline with 3-year progression-free survival (PFS) and overall survival (OS).
II. To assess the predictive value of 18F-FMISO PET/CT in lung cancer patients undergoing radiotherapy or concurrent chemoradiotherapy, as measured by BH and FB PET/CT images, and to determine whether BH PET/CT provides greater predictive capability than FB PET/CT.
SECONDARY OBJECTIVES:
I. To assess the predictive value of 18F-fludeoxyglucose (FDG) PET/CT in a group of twenty five lung cancer patients undergoing radiotherapy or concurrent chemoradiotherapy, as measured by BH and FB PET/CT images, and to determine whether BH PET/CT provides greater predictive than FB PET/CT.
II. To assess the feasibility of simultaneous 18F-FDG and 18F-FMISO PET dynamic acquisitions in a group of 5 patients undergoing radiotherapy or concurrent chemoradiotherapy.
OUTLINE:
Within 14 days of baseline 18-FDG PET/CT and before the initiation of therapy (baseline), patients receive 18F-FMISO intravenously (IV) then undergo PET/CT scans at 0-40, 90, and 180 minutes. A second set of three dynamic 18F-FMISO PET/CT scans are performed following the same sequences at 2-3 weeks after initiation of therapy. Patients also undergo 18F-FDG PET in both FB and BH modes or FB mode alone approximately 3-4 weeks after initiation of therapy (for patients undergoing radiotherapy or concurrent chemoradiotherapy only).
GROUP OF 5 PATIENTS ONLY: Within 14 days of baseline 18-FDG PET/CT and before the initiation of therapy (baseline), patients receive 18F-FMISO IV then undergo PET/CT scans at 0-40, 90, and 180 minutes. At least one day after the baseline 18F-FMISO PET/CT and before the initiation of therapy, patients receive 18F-FMISO IV followed by 18-FDG IV and undergo dynamic PET/CT scans simultaneously.
After completion of study, patients are followed up at 24 hours and then every 3-4 months for 3 years.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJacob Shin
