Imaging and Biomarkers of Hypoxia in Solid Tumors

Neoplasms Clinical Trial

Official title:

Imaging and Biomarkers of Hypoxia in Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01123005
• Other study ID #: IRB-15039
• Secondary ID: VAR0032
• Status: Terminated
• Phase: Phase 1
• First received: July 27, 2009
• Last updated: November 1, 2017
• Start date: December 2010
• Est. completion date: August 21, 2015

Study information

• Verified date: November 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: August 21, 2015
• Est. primary completion date: August 21, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Neoplasms

Intervention

Procedure:
• PET Scan
radiation calculated per patient

Drug:
• EF5
10 mCi, IV
• Carbogen
Calculated per patient
• Dichloroacetate

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	18F-EF5 uptake (tumor: blood ratio) before and after carbogen breathing for a subset of subjects.		1-5 days
Primary	18F-EF5 uptake (tumor: blood ratio) before and after administration of DCA for a subset of subjects.		1-5 days
Secondary	Levels of secreted hypoxia markers in plasma.		1-5 days
Secondary	Hypoxia gene and protein expression scores in patients undergoing biopsy or surgical resection.		1-5 days