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Imaging and Biomarkers of Hypoxia in Solid Tumors

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ClinicalTrials.gov Identifier: NCT01123005
Recruitment Status : Terminated (Logistical)
First Posted : May 13, 2010
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Billy W. Loo Jr., Stanford University

Tracking Information
First Submitted Date  ICMJE July 27, 2009
First Posted Date  ICMJE May 13, 2010
Last Update Posted Date November 6, 2017
Study Start Date  ICMJE December 2010
Actual Primary Completion Date August 21, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
  • 18F-EF5 uptake (tumor: blood ratio) before and after carbogen breathing for a subset of subjects. [ Time Frame: 1-5 days ]
  • 18F-EF5 uptake (tumor: blood ratio) before and after administration of DCA for a subset of subjects. [ Time Frame: 1-5 days ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
  • Levels of secreted hypoxia markers in plasma. [ Time Frame: 1-5 days ]
  • Hypoxia gene and protein expression scores in patients undergoing biopsy or surgical resection. [ Time Frame: 1-5 days ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imaging and Biomarkers of Hypoxia in Solid Tumors
Official Title  ICMJE Imaging and Biomarkers of Hypoxia in Solid Tumors
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Neoplasms
Intervention  ICMJE
  • Procedure: PET Scan
    radiation calculated per patient
    Other Name: positron emission tomography
  • Drug: EF5
    10 mCi, IV
    Other Name: NSC-684681
  • Drug: Carbogen
    Calculated per patient
    Other Name: Meduna's Mixture
  • Drug: Dichloroacetate
    Other Name: DCA
Study Arms  ICMJE
  • Experimental: Carbogen arm
    Interventions:
    • Procedure: PET Scan
    • Drug: EF5
    • Drug: Carbogen
  • Experimental: DCA arm
    Interventions:
    • Procedure: PET Scan
    • Drug: EF5
    • Drug: Dichloroacetate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 1, 2017)
28
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2010)
40
Actual Study Completion Date  ICMJE August 21, 2015
Actual Primary Completion Date August 21, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01123005
Other Study ID Numbers  ICMJE IRB-15039
VAR0032 ( Other Identifier: OnCore )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Billy W. Loo Jr., Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr. Billy W. Loo Jr. M.D. Ph.D. Stanford University
PRS Account Stanford University
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP