Clinical trial NCT01123005: Imaging and Biomarkers of Hypoxia in Solid Tumors
Official title: Imaging and Biomarkers of Hypoxia in Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-05-13
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: 18F-EF5 uptake (tumor: blood ratio) before and after carbogen breathing for a subset of subjects.
timeFrame: 1-5 days
measure: 18F-EF5 uptake (tumor: blood ratio) before and after administration of DCA for a subset of subjects.
timeFrame: 1-5 days
Secondary outcomes:
measure: Levels of secreted hypoxia markers in plasma.
timeFrame: 1-5 days
measure: Hypoxia gene and protein expression scores in patients undergoing biopsy or surgical resection.
timeFrame: 1-5 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr. Billy W. Loo Jr. M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: