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Imaging and Biomarkers of Hypoxia in Solid Tumors

Sponsor
Stanford University (Other)
Overall Status
Terminated
CT.gov ID
NCT01123005
Collaborator
(none)
28
Enrollment
1
Location
2
Arms
56.6
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Imaging and Biomarkers of Hypoxia in Solid Tumors
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
Aug 21, 2015
Actual Study Completion Date :
Aug 21, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 18F-EF5 uptake (tumor: blood ratio) before and after carbogen breathing for a subset of subjects. [1-5 days]

    2. 18F-EF5 uptake (tumor: blood ratio) before and after administration of DCA for a subset of subjects. [1-5 days]

    Secondary Outcome Measures

    1. Levels of secreted hypoxia markers in plasma. [1-5 days]

    2. Hypoxia gene and protein expression scores in patients undergoing biopsy or surgical resection. [1-5 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University School of Medicine Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Billy W. Loo Jr., Associate Professor of Radiation Oncology, Stanford University
    ClinicalTrials.gov Identifier:
    NCT01123005
    Other Study ID Numbers:
    • IRB-15039
    • VAR0032
    First Posted:
    May 13, 2010
    Last Update Posted:
    Nov 6, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypoxia

    Study Results

    No Results Posted as of Nov 6, 2017