Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01967927
Recruitment Status : Active, not recruiting
First Posted : October 23, 2013
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Drug: 18F-MISO Early Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Understanding GRID Radiation Therapy Effects on Human Tumor Oxygenation and Interstitial Pressure to Increase Translation of Solid Tumor Therapy
Study Start Date : December 2013
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967927


Locations
Layout table for location information
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72120
Sponsors and Collaborators
University of Arkansas
Investigators
Layout table for investigator information
Principal Investigator: Robert J Griffin, PhD University of Arkansas

Layout table for additonal information
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01967927     History of Changes
Other Study ID Numbers: 138725
138725 ( Other Grant/Funding Number: UAMS TRI )
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

Keywords provided by University of Arkansas:
carcinoma
cancer
head
neck
otolaryngology

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site