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Imaging and Biomarkers of Hypoxia in Solid Tumors

Phase 1
Terminated
Conditions
Neoplasms
Interventions
Procedure: PET Scan
Drug: Carbogen
Registration Number
NCT01123005
Lead Sponsor
Stanford University
Brief Summary

Hypoxia, meaning a lack of oxygen, has been associated strongly with a wide range of human cancers. Hypoxia occurs when tumor growth exceeds the ability of blood vessels to supply the tumor with oxygenated blood. It is currently understood that hypoxic tumors are more aggressive. Current methods for measuring hypoxia include invasive procedures such as tissue biopsy, or insertion of an electrode into the tumor. EF5-PET may be a non-invasive way to measure tumor hypoxia.

Detailed Description

To establish PET imaging with the tracer EF5 as an accurate and reliable method for measuring the oxygen content of a tumor and to establish the measurement of secreted markers in blood as an accurate and reliable method for measuring the oxygen content of a tumor.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
28
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Carbogen armPET Scan-
Carbogen armEF5-
Carbogen armCarbogen-
DCA armPET Scan-
DCA armEF5-
DCA armDichloroacetate-
Primary Outcome Measures
NameTimeMethod
18F-EF5 uptake (tumor: blood ratio) before and after carbogen breathing for a subset of subjects.1-5 days
18F-EF5 uptake (tumor: blood ratio) before and after administration of DCA for a subset of subjects.1-5 days
Secondary Outcome Measures
NameTimeMethod
Levels of secreted hypoxia markers in plasma.1-5 days
Hypoxia gene and protein expression scores in patients undergoing biopsy or surgical resection.1-5 days

Trial Locations

Locations (1)

Stanford University School of Medicine

🇺🇸

Stanford, California, United States

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