A Pilot Study of FDG-PET Variability to Establish Biology-Guided Treatment Planning Feasibility for Stereotactic Body Radiation Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in total lesion glycolysis values measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of thoracic stereotactic body radiation therapy (SBRT) target volumes
研究概览
简要总结
This trial studies how well fludeoxyglucose F-18 - positron emission tomography (PET) works in planning radiation therapy in participants with early non-small cell lung cancer, early stage lung cancer, or cancer that has spread to lungs from other parts of the body. Using PET in addition to the standard computed tomography to plan radiation therapy for cancer may help doctors to maximize the dose to the cancer and minimize the dose to normal tissues.
详细描述
PRIMARY OBJECTIVE:
To determine the maximum inter-fraction variability of fludeoxyglucose F-18 (18-F FDG)-PET activity of thoracic tumor treatment volumes through a 5-fraction stereotactic body radiation therapy (SBRT) course as it relates to the planning feasibility of emission-guided radiation therapy, or biologically-guided radiation therapy (BgRT).
SECONDARY OBJECTIVES:
I. To compare similar inter-fraction variability of FDG-PET activity for non-thoracic SBRT target volumes for the purpose of determining the feasibility of BgRT.
II. To compare dosimetric endpoints for primary tumor coverage and dose to organs at risk between conventional SBRT planning and simulated BgRT, or emission-guided radiation therapy planning for thoracic and non-thoracic targets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are offered radiotherapy using a 5-fraction stereotactic body radiation therapy course, at the recommendation of the treating radiation oncologist
- •Patients with early non-small cell lung carcinoma, or clinically-diagnosed early stage lung cancer, or pulmonary metastases
- •Patients with a limited (1-5) number of metastatic foci outside of the thorax who are candidates for consolidative treatment with SBRT
- •Patient with either a single focus or multiple foci (multi-isocentric planning) of disease in the thorax amenable to SBRT with at least one focus with at least 1.5 cm or larger in its largest diameter
- •Patients who are planned to receive either chemotherapy, targeted therapy, immunotherapy, or no additional cancer-directed drug therapy
排除标准
- •Prior radiation therapy which would provide significant dose overlap with the planned target volume(s) delivered within 30 days of enrollment or registration
- •Major invasive surgical procedure occurring between the first treatment-eligible PET/CT examination and end of radiotherapy that would affect the treatment target region
- •Patients with minimal FDG-avidity localized to the planned treatment target (e.g. maximum standardized uptake value [SUV] < 4.0)
- •Pregnancy
研究组 & 干预措施
Diagnostic (FDG-PET, SBRT)
Participants receive fludeoxyglucose F-18 IV and after 60 minutes undergo positron emission tomography (PET) within 4 weeks of the first planned stereotactic body radiation therapy (SBRT) fraction, prior to the second planned fraction, and prior to the fifth planned fraction.
干预措施: Fludeoxyglucose F-18 (Drug)
Diagnostic (FDG-PET, SBRT)
Participants receive fludeoxyglucose F-18 IV and after 60 minutes undergo positron emission tomography (PET) within 4 weeks of the first planned stereotactic body radiation therapy (SBRT) fraction, prior to the second planned fraction, and prior to the fifth planned fraction.
干预措施: Positron Emission Tomography (PET) (Procedure)
Diagnostic (FDG-PET, SBRT)
Participants receive fludeoxyglucose F-18 IV and after 60 minutes undergo positron emission tomography (PET) within 4 weeks of the first planned stereotactic body radiation therapy (SBRT) fraction, prior to the second planned fraction, and prior to the fifth planned fraction.
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
结局指标
主要结局
Change in total lesion glycolysis values measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of thoracic stereotactic body radiation therapy (SBRT) target volumes
时间窗: Up to 6 weeks from study start
Total lesion glycolysis values across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients and for every tumor treated with SBRT.
Change in metabolic tumor volumes measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of thoracic stereotactic body radiation therapy (SBRT) target volumes
时间窗: Up to 6 weeks from study start
Metabolic tumor volumes across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients and for every tumor treated with SBRT.
次要结局
- Change in metabolic tumor volumes measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of non-thoracic stereotactic body radiation therapy (SBRT) target volumes(Up to 6 weeks from study start)
- Change in total lesion glycolysis values measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of non-thoracic stereotactic body radiation therapy (SBRT) target volumes(Up to 6 weeks from study start)
研究者
Kristin Higgins
Principal Investigator
Emory University