drugset / Trial / NCT01967927

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

NCT01967927

Phase 0 Withdrawn University of Arkansas
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2013-12
Primary completion
2021-08-17
Completion
2021-08-17

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-fluoromisonidazole Diagnostic / imaging agent