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Imaging and Biomarkers of Hypoxia in Solid Tumors

NCT ID: NCT01123005

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2015-08-21

Brief Summary

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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

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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.

Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Carbogen arm

Group Type EXPERIMENTAL

PET Scan

Intervention Type PROCEDURE

radiation calculated per patient

EF5

Intervention Type DRUG

10 mCi, IV

Carbogen

Intervention Type DRUG

Calculated per patient

DCA arm

Group Type EXPERIMENTAL

PET Scan

Intervention Type PROCEDURE

radiation calculated per patient

EF5

Intervention Type DRUG

10 mCi, IV

Dichloroacetate

Intervention Type DRUG

Interventions

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PET Scan

radiation calculated per patient

Intervention Type PROCEDURE

EF5

10 mCi, IV

Intervention Type DRUG

Carbogen

Calculated per patient

Intervention Type DRUG

Dichloroacetate

Intervention Type DRUG

Other Intervention Names

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positron emission tomography NSC-684681 Meduna's Mixture DCA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Billy W. Loo Jr.

Associate Professor of Radiation Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Billy W. Loo Jr. M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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VAR0032

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-15039

Identifier Type: -

Identifier Source: org_study_id