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Imaging and Biomarkers of Hypoxia in Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01123005
First received: July 27, 2009
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

We hope to find safer, noninvasive methods for measuring tumor hypoxia. 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 make this measurement.


Condition Intervention
Neoplasms
Procedure: PET Scan
Drug: EF5
Drug: Carbogen

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Imaging and Biomarkers of Hypoxia in Solid Tumors

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
  • 18F-EF5 uptake (tumor: blood ratio) before and after administration of DCA for a subset of subjects. [ Time Frame: 1-5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Levels of secreted hypoxia markers in plasma. [ Time Frame: 1-5 days ] [ Designated as safety issue: No ]
  • Hypoxia gene and protein expression scores in patients undergoing biopsy or surgical resection. [ Time Frame: 1-5 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood and tumor samples


Estimated Enrollment: 40
Study Start Date: December 2010
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed Description:

To establish PET imaging with the tracer FMISO 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any solid tumor malignancies of any stage meeting all of the following criteria: 1. Tumor is accessible for minimally invasive biopsy (i.e., not requiring general anesthesia; e.g., FNA, core needle, punch, excision under local anesthesia) OR surgical resection is the planned initial treatment regardless of participation in this study; 2. Minimum tumor dimension is at least 1 cm (to ensure it is above the detection threshold of PET imaging).

Criteria

Inclusion Criteria:3.1.1 Eligible Diseases

Any solid tumor malignancies of any stage meeting all of the following criteria: 1. Tumor is accessible for minimally invasive biopsy (i.e., not requiring general anesthesia; e.g., FNA, core needle, punch, excision under local anesthesia) OR surgical resection is the planned initial treatment regardless of participation in this study; 2. 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.

In addition, a subset of patients will be eligible for the carbogen breathing portion of the study if their initial 18F-EF5 scan demonstrates increased tumor uptake (tumor:blood ratio > 1.5).

3.1.2 Allowable type and amount of prior therapy: 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.

3.1.4 Patients must be greater than or equal to eighteen years of age.

3.1.5 ECOG or Karnofsky Performance Status will not be employed, but patients will need to be sufficiently healthy to tolerate all study procedures.

3.1.6 Requirements for organ and marrow function are not applicable to this study, but function will need to be sufficient to undergo planned therapy.

3.1.7 Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:Pregnant or nursing patients will be excluded from the study.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123005

Contacts
Contact: Laura Gable 650-736-0798 lauraw1@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Laura Gable    650-736-0798    lauraw1@stanford.edu   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: Dr. Billy W. Loo Jr. M.D. Ph.D.         
Sub-Investigator: Quynh-Thu Le         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr. Billy W. Loo Jr. M.D. Ph.D. Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01123005     History of Changes
Other Study ID Numbers: VAR0032
Study First Received: July 27, 2009
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014