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Imaging and Biomarkers of Hypoxia in Solid Tumors

Primary Purpose

Neoplasms

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PET Scan

EF5

Carbogen

Dichloroacetate

About this trial

This is an interventional diagnostic trial for Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Carbogen arm

DCA arm

Arm Description

Outcomes

Primary Outcome Measures

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

18F-EF5 uptake (tumor: blood ratio) before and after administration of DCA for a subset of subjects.

Secondary Outcome Measures

Levels of secreted hypoxia markers in plasma.

Hypoxia gene and protein expression scores in patients undergoing biopsy or surgical resection.

Full Information

NCT ID

NCT01123005

First Posted

July 27, 2009

Last Updated

November 1, 2017

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT01123005

Brief Title

Imaging and Biomarkers of Hypoxia in Solid Tumors

Official Title

Imaging and Biomarkers of Hypoxia in Solid Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Terminated

Why Stopped

Logistical

Study Start Date

December 2010 (undefined)

Primary Completion Date

August 21, 2015 (Actual)

Study Completion Date

August 21, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasms

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Carbogen arm

Arm Type

Experimental

Arm Title

DCA arm

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

PET Scan

Other Intervention Name(s)

positron emission tomography

Intervention Description

radiation calculated per patient

Intervention Type

Drug

Intervention Name(s)

EF5

Other Intervention Name(s)

NSC-684681

Intervention Description

10 mCi, IV

Intervention Type

Drug

Intervention Name(s)

Carbogen

Other Intervention Name(s)

Meduna's Mixture

Intervention Description

Calculated per patient

Intervention Type

Drug

Intervention Name(s)

Dichloroacetate

Other Intervention Name(s)

DCA

Primary Outcome Measure Information:

Title

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

Time Frame

1-5 days

Title

18F-EF5 uptake (tumor: blood ratio) before and after administration of DCA for a subset of subjects.

Time Frame

1-5 days

Secondary Outcome Measure Information:

Title

Levels of secreted hypoxia markers in plasma.

Time Frame

1-5 days

Title

Hypoxia gene and protein expression scores in patients undergoing biopsy or surgical resection.

Time Frame

1-5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Imaging and Biomarkers of Hypoxia in Solid Tumors

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