Monitoring Blood Flow and Metabolic Activity in Malignant Tissue of Head and Neck Region Using the Lara Device
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Percentage of Tests That Input Function (IF) Could Be Calculated
研究概览
简要总结
This study will investigate the ability of Lucerno Dynamics Lara sensor when placed on the palpable carotid artery (or femoral artery) to monitor blood flow following the injection of 18-FDG and to distinguish peak flow in tumor versus tissue uptake. Investigators will then assess if differences in tumor versus tissue correlates with tumor response.
详细描述
Primary Objective: To determine if Lara sensors placed over the carotid and femoral arteries can measure the plasma activity of 18 F-fludeoxyglucose (18-FDG) at time of injection and determine if that peak activity in the artery can be distinguished from peak activity in malignant tissue to provide enough information to obtain the arterial input function.
Secondary Objective: To evaluate changes (baseline to post treatment) in tissue uptake at first pass (AUC and time to peak blood flow) and during the 60-minute period (metabolic activity) leading to the , positron emission tomography (PET) scan. This data is to be collected from the Lucerno Device placed over the carotid and femoral arteries monitoring 18 F-fludeoxyglucose (18-FDG) activity in blood and malignant tissue throughout the pre positron emission tomography (PET) scan period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Squamous cell carcinoma of the nasopharynx, oral cavity, oropharynx or hypopharynx with palpable adenopathy in the neck. Biopsy proven within the last 90 days.
- •Squamous cell carcinoma of the larynx regardless of lymph node status. Biopsy proven within the last 90 days.
- •Age 18 or greater.
- •Receiving definitive radiation therapy at Wake Forest University with or without concurrent systematic therapy.
- •Participants must be able to provide study specific informed consent prior to study entry.
- •Presence of metastatic disease is not an
排除标准
- •provided subject will be receiving definitive doses of radiation to the local and regional disease.
- •Exclusion Criteria
- •Cancers of the head and neck other than those stated above. This would include squamous cell carcinoma of unknown primary.
- •No measurable disease in the head and neck (ie planned adjuvant radiation therapy for allowable cancers with high risk pathology following definitive surgery).
- •Persons receiving less than curative doses of radiation.
- •Age under 18
- •Unable or unwilling to tolerate PET/CT scan
- •Unable or unwilling to receive definitive treatment of their cancer at Wake Forest University
- •Pregnant women
- •Participants who present having already undergone a PET/CT will not be eligible for this study-because an important element of this trial is the assessment of 18-FDG uptake changes in response to treatment
研究组 & 干预措施
Lara Device Scan
This imaging study will be obtained strictly for the research purposes of mid-treatment assessment of blood flow and uptake kinetics analysis
干预措施: Lara Scan (Device)
Lara Device Scan
This imaging study will be obtained strictly for the research purposes of mid-treatment assessment of blood flow and uptake kinetics analysis
干预措施: PET/CT Scan - Pre-treatment and Post-treatment (Diagnostic Test)
结局指标
主要结局
Percentage of Tests That Input Function (IF) Could Be Calculated
时间窗: At baseline
If input function can be calculated on five (5) or more (out of 10) patients, then investigators will consider this a feasible procedure. Input function is calculated using time-activity curves (TAC) from the arterial blood flow detector and integrating the signal over time. Peak and minimum values of each of the four (4) Lara detector time-activity curves (TAC) will be recorded to determine a range of expected values and if they are different.
次要结局
- Change in Time to Peak Arterial Blood Flow(Baseline up to 120 days after completion of treatment)
- Change in Areas Under the Curve (AUC) Measurements(Baseline up to 120 days after completion of treatment)