The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: EF5 in Measuring Tumor Hypoxia in Patients With Stage I-III Non-Small Cell Lung Cancer
Official Title: Pilot Phase II Research Study of EF5 to Measure Tumor Hypoxia in Patients With Non-small Cell Lung Cancer
Study ID: NCT02154399
Brief Summary: This pilot phase II trial studies how well EF5 works in measuring lack of tumor oxygen, hypoxia, in patients with stage I-III non-small cell lung cancer. EF5 may be effective in measuring the lack of oxygen in lung tumors and may allow doctors to plan better treatment.
Detailed Description: PRIMARY OBJECTIVES: I. Assess the frequency and degree of hypoxia as measured by EF5 binding in patients with non-small cell lung cancer. II. Correlate hypoxia as measured by EF5 binding with potential serum/plasma markers of hypoxia in patients with non-small cell lung cancer. III. Correlate hypoxia as measured by EF5 binding with tissue markers of hypoxia in patients with non-small cell lung cancer. IV. Correlate hypoxia as measured by EF5 binding with tumor angiogenesis in patients with non-small cell lung cancer. V. Correlated hypoxia as measured by EF5 binding with apoptosis in patients with non-small cell lung cancer. VI. Measure and characterize tumor perfusion in relationship to hypoxia in patients with non-small cell lung cancer. VII. Correlate tumor perfusion to microvessel density in tumor samples in patients with non-small cell lung cancer. VIII. Determine the longevity of EF5 adducts in human lung tumors. OUTLINE: Patients receive EF5 intravenously (IV) over 1-2.5 hours. Beginning 24-55 hours later, patients undergo tumor hypoxia measurement using a polarographic needle electrode and intraoperative tumor measurement before undergoing surgical biopsy or resection. After completion of study treatment, patients are followed up for 4-6 weeks.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Durham Veterans Affairs Medical Center, Durham, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Name: Michael Kelley
Affiliation: Duke University
Role: PRINCIPAL_INVESTIGATOR