Cutaneous Tumors Clinical Trial
Official title:
Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry
Oxygen has a critical role in the metabolism of tumors and normal tissues and is a key determinant of sensitivity of tissues to ionizing radiation. Knowledge of the relationship between the partial pressure of oxygen (pO2) and radiation sensitivity has been exploited in strategies to enhance oxygenation or to sensitize hypoxic cells to radiation. This study involves taking at least one measurement of the oxygen level in the patient's tumor before, during, and after breathing oxygen through a facemask. The goal of the measurements is to learn more about changes in tumor oxygen levels in response to breathing extra oxygen and standard treatments like chemotherapy and radiation therapy, so that in the future we have a better understanding of how to best use these treatments to improve their ability to fight cancer. By taking measurements of a variety of tumor types undergoing a variety of treatments, we will gain valuable information towards assessing our underlying hypothesis that repeated measurements of tissue oxygen levels can be used to optimize cancer therapy, especially radiation therapy, so that the therapy is applied in a way that maximizes the therapeutic ratio. All patients in this study will receive standard of care therapy for their cancer at the discretion of their treating physician(s).
This protocol is designed to demonstrate the clinical feasibility of using in vivo EPR oximetry to obtain clinically useful measurements of tumor oximetry from cancer patients. By taking measurements of a variety of tumor types undergoing a variety of treatments, we will gain valuable information towards assessing our underlying hypothesis that repeated measurements of tissue oxygen levels can be used to optimize cancer therapy, especially radiation therapy, so that the therapy is applied in a way that maximizes the therapeutic ratio. All patients in this study will receive standard of care therapy for their cancer at the discretion of their treating physician(s). All subjects will be assigned to one of the four cohorts below for which they qualify;there is no randomization and no stratification within the cohorts. All measurements will be carried out before, during and after hyperoxygenation therapy * Not all tumor's may be amenable to the SPOTChip or India ink measurements. Similarly, some patients may refuse one or the other. In either of these cases, measurements may still be made with only one of the two probes. - For patients in whom measurements are being made while on systemic therapy, the goal of the systemic therapy may be neoadjuvant in curative patients or palliative in metastatic patients. - If patients receive chemotherapy at intervals of less than q3 weeks, oximetry measurements should still only be taken at 3-4 week intervals with every other cycle. Patients on systemic therapy for prolonged. The duration of the EPR oximetry measurements will vary t depending on the type of therapy a given patient receives (which determines the cohort they are in). Patients who undergo pre-operative EPR oximetry measurements will not have any follow-up measurements after surgery since the tumor has been excised. Patients who undergo radiation or systemic therapy will have EPR oximetry measurements during treatment, 1 month after completing radiation or systemic therapy and none thereafter. Adverse events specifically related to the India ink injection and EPR oximetry measurements will be followed until resolution, stabilization, or until it has been determined that study participation is not the cause. Adverse events related to cancer-directed therapies (e.g. radiation or systemic therapy) will not be monitored on this study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT01060319 -
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