Imaging and Biomarkers of Hypoxia in Solid Tumors

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.

Study Overview

• Status: Terminated
• Conditions: Neoplasms
• Intervention / Treatment: Procedure: PET Scan; Drug: EF5; Drug: Carbogen; Drug: Dichloroacetate

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carbogen arm	Procedure: PET Scan; radiation calculated per patient; Other Names: positron emission tomography; Drug: EF5; 10 mCi, IV; Other Names: NSC-684681; Drug: Carbogen; Calculated per patient; Other Names: Meduna's Mixture
Experimental: DCA arm	Procedure: PET Scan; radiation calculated per patient; Other Names: positron emission tomography; Drug: EF5; 10 mCi, IV; Other Names: NSC-684681; Drug: Dichloroacetate; Other Names: DCA

What is the study measuring?

Primary Outcome Measures

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 Measures

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Dr. Billy W. Loo Jr. M.D. Ph.D., Stanford University

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): August 21, 2015
• Study Completion (Actual): August 21, 2015

Study Registration Dates

• First Submitted: July 27, 2009
• First Submitted That Met QC Criteria: May 12, 2010
• First Posted (Estimate): May 13, 2010

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 1, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: IRB-15039; VAR0032 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No