This research trial studies fluorine F 18 EF5 (18F-EF5) positron emission tomography (PET) and biospecimen collection in measuring hypoxia in patients with solid tumors. Hypoxia is a lack of oxygen and occurs when tumor growth does not allow blood vessels to supply the tumor with blood. Diagnostic procedures, such as 18F-EF5 PET, may help find hypoxic tissue and provide a noninvasive alternative that is just as accurate as current, invasive methods. Collecting and storing samples of blood and tissue to study in the laboratory may help identify biomarkers related to hypoxia. 18F-EF5 PET and biospecimen collection may work better in measuring hypoxia in patients with solid tumors.
Additional locations may be listed on ClinicalTrials.gov for NCT01123005.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To validate PET imaging with the tracer fluorine F 18 EF5 (18F-EF5) as an indicator of functionally and prognostically significant tumor hypoxia.
II. Measure the change in 18F-EF5 uptake pre- and post-carbogen breathing. (Carbogen breathing sub-study)
III. To measure the change in 18F-EF5 uptake pre- and post-sodium dichloroacetate (DCA) administration. (DCA administration sub-study)
SECONDARY OBJECTIVES:
I. To validate a panel of secreted markers in plasma as an indicator of functionally and prognostically significant tumor hypoxia.
II. To correlate EF5-PET imaging with gene and protein biomarkers of hypoxia.
OUTLINE:
Patients undergo standard of care 18F-EF5 PET scan and phlebotomy. Patients with high 18F-EF5 uptake undergo carbogen breathing and a second 18F-EF5 PET scan. Patients with low 18F-EF5 uptake receive DCA orally (PO) and undergo a second 18F-EF5 PET scan. Patients scheduled for biopsy or surgical resection also undergo collection of blood and tissue samples for tissue analysis and protein expression.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorBilly W. Loo
