Imaging and Biomarkers of Hypoxia in Solid Tumors

Imaging and Biomarkers of Hypoxia in Solid Tumors

Sponsors

Lead Sponsor: Stanford University

Source 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.

Overall Status Terminated
Start Date 2010-12-01
Completion Date 2015-08-21
Primary Completion Date 2015-08-21
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Measure Time Frame
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
Enrollment 28
Condition
Intervention

Intervention Type: Procedure

Intervention Name: PET Scan

Description: radiation calculated per patient

Other Name: positron emission tomography

Intervention Type: Drug

Intervention Name: EF5

Description: 10 mCi, IV

Other Name: NSC-684681

Intervention Type: Drug

Intervention Name: Carbogen

Description: Calculated per patient

Arm Group Label: Carbogen arm

Other Name: Meduna's Mixture

Intervention Type: Drug

Intervention Name: Dichloroacetate

Arm Group Label: DCA arm

Other Name: DCA

Eligibility

Criteria:

INCLUSION CRITERIA - Any solid tumor malignancies of any stage meeting all of the following criteria: Minimum tumor dimension is at least 1 cm (to ensure it is above the detection threshold of PET imaging). Examples include but are not limited to: locally advanced squamous cell carcinoma of the head and neck to be treated by either initial surgery or primary chemoradiotherapy; inoperable non-small cell lung cancer or pancreatic carcinoma to be treated with stereotactic radiotherapy, which may be biopsied again at the time of percutaneous needle delivery of implanted fiducial markers. - Patients with newly diagnosed malignancies should not have initiated treatment for their disease before participating in this study. Patients with recurrent or second malignancies may have had prior therapy as appropriate for their disease, but should have completed all prior treatment at least 30 days before participation in this study and should not have initiated new treatment for the current problem. - Greater than or equal to eighteen years of age. - Sufficiently healthy to tolerate all study procedures. - Organ and marrow function sufficient to undergo planned therapy. - Ability to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA • Pregnant or nursing

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Dr. Billy W. Loo Jr. M.D. Ph.D. Principal Investigator Stanford University
Location
Facility: Stanford University School of Medicine
Location Countries

United States

Verification Date

2017-11-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Stanford University

Investigator Full Name: Billy W. Loo Jr.

Investigator Title: Associate Professor of Radiation Oncology

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Carbogen arm

Type: Experimental

Label: DCA arm

Type: Experimental

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Sequential Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

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