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Clinical Trials/NCT01123005
NCT01123005
Terminated
Phase 1

Imaging and Biomarkers of Hypoxia in Solid Tumors

Stanford University1 site in 1 country28 target enrollmentDecember 2010

Overview

Phase
Phase 1
Intervention
PET Scan
Conditions
Neoplasms
Sponsor
Stanford University
Enrollment
28
Locations
1
Primary Endpoint
18F-EF5 uptake (tumor: blood ratio) before and after carbogen breathing for a subset of subjects.
Status
Terminated
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2010
End Date
August 21, 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Billy W. Loo Jr.

Associate Professor of Radiation Oncology

Stanford University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Carbogen arm

Intervention: PET Scan

Carbogen arm

Intervention: EF5

Carbogen arm

Intervention: Carbogen

DCA arm

Intervention: PET Scan

DCA arm

Intervention: EF5

DCA arm

Intervention: Dichloroacetate

Outcomes

Primary Outcomes

18F-EF5 uptake (tumor: blood ratio) before and after carbogen breathing for a subset of subjects.

Time Frame: 1-5 days

18F-EF5 uptake (tumor: blood ratio) before and after administration of DCA for a subset of subjects.

Time Frame: 1-5 days

Secondary Outcomes

  • 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)

Study Sites (1)

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