Understanding GRID Radiation Therapy Effects on Human Tumor Oxygenation and Interstitial Pressure to Increase Translation of Solid Tumor Therapy

August 17, 2021 updated by: University of Arkansas

To estimate the mean and standard deviation (SD) of the post-treatment decreases in the interstitial fluid pressure and hypoxia-specific PET-scan signal from GRID-treated tumors in patients with locally advanced squamous-cell carcinoma of the head and neck.

The possible effects of GRID radiotherapy on tumor oxygenation levels and interstitial fluid pressure within the tumors will be measured by assessing the trend and statistical significance of the difference in values for each condition obtained prior to and just after GRID exposure in each subject enrolled in the study. We expect that there may be a trend for increases in tumor oxygenation and decreases in interstitial fluid pressure which would indicate that more accurately timed additional chemotherapy and radiation therapy would improve overall patient outcomes.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72120
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 - 80 years of age
  • Karnofsky performance status greater than 70 or ECOG ≥ 2
  • Cytological or histological documentation of squamous cell carcinoma of the head and neck, including the tongue, with a minimum tumor size of 6cm in any dimension.

  • History of adequate hepatic function (endoscopic or percutaneous drainage as needed):

    a. AST (SGOT) / ALT (SGPT) ≤ 5X institutional ULN

  • Chemotherapy naive

  • History of adequate renal and bone marrow function:

    1. Leukocytes ≥ 3000/uL
    2. ANC ≥ 1500/uL
    3. Platelets ≥ 100000/UI
    4. Serum Creatinine ≤ 2.0 mg/dL

Exclusion Criteria:

  • Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence
  • Subjects with active infections such as pneumonia, or wound infections that would preclude study procedures
  • Subjects with known presence of central nervous system or brain metastases
  • Subjects with prior radiotherapy to the head and neck region
  • Subjects will be excluded if deemed unable to comply with study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GRID 18F-MISO
Drug: 18F-MISO
A radiolabeled imaging agent that has been used for investigating tumor hypoxia with positron emission tomography (PET).
Other Names:
  • [18F]FMISO
  • [18F]FLUOROMISONIDAZOLE
  • 1H-1-(3-[18F]-FLUORO-2-HYDROXY-PROPYL)-2-NITRO-IMIDAZOLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To estimate the mean and standard deviation of the decrease in interstitial fluid pressure in tumors within 72 hours after GRID treatment.
Time Frame: within 72 hours after GRID treatment
within 72 hours after GRID treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Investigators

  • Principal Investigator: Robert J Griffin, PhD, University of Arkansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

August 17, 2021

Study Completion (Actual)

August 17, 2021

Study Registration Dates

First Submitted

October 18, 2013

First Submitted That Met QC Criteria

October 18, 2013

First Posted (Estimate)

October 23, 2013

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 138725 (Other Grant/Funding Number: UAMS TRI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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