Imaging and Biomarkers of Hypoxia in Solid Tumors

Stanford University

Status and phase: Terminated; Phase 1

Conditions: Neoplasms

Treatments: Drug: Dichloroacetate; Procedure: PET Scan; Drug: Carbogen; Drug: EF5

Study type: Interventional

Funder types: Other

Identifiers

NCT01123005

VAR0032 (Other Identifier)

IRB-15039

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Carbogen arm

Experimental group

Treatment:

Drug: EF5

Drug: Carbogen

Procedure: PET Scan

DCA arm

Experimental group

Treatment:

Drug: EF5

Drug: Dichloroacetate

Procedure: PET Scan