Imaging and Biomarkers of Hypoxia in Solid Tumors

NCT01123005 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: IRB-15039VAR0032
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

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

  1-5 days

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

  1-5 days

Secondary Outcomes (2)

• Levels of secreted hypoxia markers in plasma.

  1-5 days

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

  1-5 days

Study Arms (2)

Carbogen arm

EXPERIMENTAL

Procedure: PET Scan; Drug: EF5; Drug: Carbogen

DCA arm

EXPERIMENTAL

Procedure: PET Scan; Drug: EF5; Drug: Dichloroacetate

Interventions

PET Scan PROCEDURE

radiation calculated per patient

Also known as: positron emission tomography

Carbogen arm; DCA arm

EF5 DRUG

10 mCi, IV

Also known as: NSC-684681

Carbogen arm; DCA arm

Carbogen DRUG

Calculated per patient

Also known as: Meduna's Mixture

Carbogen arm

Dichloroacetate DRUG

Also known as: DCA

DCA arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or nursing

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Magnetic Resonance Spectroscopy; carbogen; Dichloroacetic Acid

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Chloroacetates; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Dr. Billy W. Loo Jr. M.D. Ph.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiation Oncology

Study Record Dates

• First Submitted: July 27, 2009
• First Posted: May 13, 2010
• Study Start: December 1, 2010
• Primary Completion: August 21, 2015
• Study Completion: August 21, 2015
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)