Understanding GRID Radiation Therapy Effects on Human Tumor Oxygenation and Interstitial Pressure to Increase Translation of Solid Tumor Therapy
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|ClinicalTrials.gov Identifier: NCT01967927|
Recruitment Status : Active, not recruiting
First Posted : October 23, 2013
Last Update Posted : July 25, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: GRID 18F-MISO||
A radiolabeled imaging agent that has been used for investigating tumor hypoxia with positron emission tomography (PET).
- 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 ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967927
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72120|
|Principal Investigator:||Robert J Griffin, PhD||University of Arkansas|