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Imaging and Biomarkers of Hypoxia in Solid Tumors

This study has been terminated.
(Logistical)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01123005
First Posted: May 13, 2010
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Billy W. Loo Jr., Stanford University
  Purpose
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 Intervention Phase
Neoplasms Procedure: PET Scan Drug: EF5 Drug: Carbogen Drug: Dichloroacetate Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging and Biomarkers of Hypoxia in Solid Tumors

Further study details as provided by Billy W. Loo Jr., Stanford University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 28
Study Start Date: December 2010
Study Completion Date: August 21, 2015
Primary Completion Date: August 21, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carbogen arm 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
Experimental: DCA arm Procedure: PET Scan
radiation calculated per patient
Other Name: positron emission tomography
Drug: EF5
10 mCi, IV
Other Name: NSC-684681
Drug: Dichloroacetate
Other Name: DCA

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123005


Locations
United States, California
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
  More Information

Responsible Party: Billy W. Loo Jr., Associate Professor of Radiation Oncology, Stanford University
ClinicalTrials.gov Identifier: NCT01123005     History of Changes
Other Study ID Numbers: IRB-15039
VAR0032 ( Other Identifier: OnCore )
First Submitted: July 27, 2009
First Posted: May 13, 2010
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
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
Signs and Symptoms, Respiratory
Signs and Symptoms