Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Assess the change in oxygenation of cutaneous tumors from hyperoxygenation therapy during the standard therapy for the disease
研究概览
简要总结
This protocol will take measurements of a variety of tumors involving the skin in order to assess changes in tumor oxygen from hyperoxygenation therapy and standard cancer-directed treatments, to demonstrate the clinical feasibility of using in vivo Electron Paramagnetic Resonance (EPR) Oximetry to obtain clinically useful measurements of tumor oxygen levels from cancer patients.
详细描述
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 for which they qualify; there is no randomization and no stratification within the cohorts.
Cohort 1 - Patients who will receive definitive surgery for a primary malignancy of the skin
Cohort 2 - Patients who will receive definitive radiation (+/- concurrent systemic therapy) for a primary malignancy of the skin
Cohort 3 - Patients who will receive palliative radiation (+/- concurrent systemic therapy) for any tumor involving the skin
Cohort 4 - Patients who will receive systemic therapy alone (without radiation) for any tumor involving the skin
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathology-proven (histology or cytology) malignancy of any histology and site of origin
- •Visible tumor (primary or metastasis) involving the skin of at least 6 mm in diameter
- •Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential
排除标准
- •Implanted electric, magnetic or mechanically activated devices like a pacemaker, defibrillator, nerve stimulator, cochlear implant or portable infusion pump. Also individuals who have any non-MRI compatible implants
- •Individuals who have a ferromagnetic foreign body located in their body
- •Prior adverse reaction to a charcoal product (e.g., a local hypersensitive response from a black tattoo or from ingestion of activated charcoal)
- •Prior adverse reaction to gum Arabic, which is an ingredient in the India ink
- •Prior allergic reaction to medical adhesives
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant or lactating women. There is no known harm to the woman or her fetus from participating; this is precautionary only
结局指标
主要结局
Assess the change in oxygenation of cutaneous tumors from hyperoxygenation therapy during the standard therapy for the disease
时间窗: From the first oxygen measurement to one month after the completing standard therapy
Tumor oxygen kinetics will be measured by EPR oximetry under ambient conditions, during hyperoxygenation therapy (100% O2 administered via a non-rebreather face mask), and immediately after hyperoxygenation therapy.
次要结局
- To characterize temporal variations in oxygenation of cutaneous tumors over a course of local radiation therapy and/or systemic chemotherapy or immunotherapy(From the first oxygen measurement to one month after the completing standard therapy)
研究者
Todd Tenenholz
Radiation Oncologist, Assistant Professor
West Virginia University