A Pilot Study of Glutamine PET Imaging of Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- To establish the ability of the 18F-FSPG PET imaging to detect tumors in patients with (HNSCC) Head and Neck Squamous Cell Carcinoma NSCC.
研究概览
简要总结
We propose a focused, prospective pilot clinical imaging trial to evaluate 11C-Gln PET/CT followed by 18F-FSPG PET/CT in 20 HNSCC patients. Imaging metrics that are common to PET (e.g. SUVmax, peak or mean) will be determined.
This study will also allow the acquisition of additional safety and biodistribution data, as, to date, only a limited number of patients have been evaluated with 11C-Gln as a direct PET imaging biomarker of Gln uptake. To date, no adverse side effects have been observed. We do not anticipate any toxicity since this tracer is a naturally-occurring essential amino acid in high abundance and is administered at sub-pharmacologic doses.
A long-term goal of these preliminary studies is to validate the utility of Gln PET imaging metrics for HNSCC and to expand this imaging technique to additional patients in prospective cohorts of patients with HNSCC.
详细描述
Primary Objective:
The primary objective of this trial is to evaluate the ability of 11C-Gln and 18F-FSPG PET imaging to detect tumors in patients with HNSCC.
Hypotheses: 11C-Gln PET and 18F-FSPG PET will yield standardized uptake values SUVs; within HNSCC primary and metastatic lesions that are significantly higher relative to SUV of background tissue.
Primary Outcome Measures
11C-Gln standardized uptake value (SUV) including SUVmax, SUVpeak, and SUVmean for tumors and normal tissue 18F-FSPG standardized uptake value (SUV) including SUVmax, SUVpeak, and SUVmean for tumors and normal tissue
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
- •≥18 years of age;
- •Pathologically or cytologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC);
- •Documented results from (or scheduled to undergo) CT or MRI as a SOC procedure within 42 days prior to baseline investigational 11C-Gln PET/CT and 18F-FSPG PET/CT;
- •Measurable disease by RECIST v1.1 defined as tumor lesions with a longest diameter ≥ 10 mm and/or malignant lymph nodes with a short axis diameter ≥ 15 mm.
- •Ability to provide written informed consent in accordance with institutional policies.
- •Non-English speaking subject will be included. Verbal Translation Preparative Sheet (VTPS) short form will be utilized in consent non-English speaking subject
排除标准
- •Body weight ≥400 pounds or body habitus or disability that will not permit the imaging protocol to be performed;
- •Pregnant or lactating females.
- •Have an allergy to intravenous contrast
研究组 & 干预措施
PET scan
PET scans: an 11C-Glutamine PET scan and an 18F-FSPG PET scan. A small tube (called an IV) will be placed in a vein in your arm through which you will receive the radioactive material for the PET scan(s).
干预措施: 18F-FSPG (Drug)
PET scan
PET scans: an 11C-Glutamine PET scan and an 18F-FSPG PET scan. A small tube (called an IV) will be placed in a vein in your arm through which you will receive the radioactive material for the PET scan(s).
干预措施: 11C-Glutamine (Drug)
结局指标
主要结局
To establish the ability of the 18F-FSPG PET imaging to detect tumors in patients with (HNSCC) Head and Neck Squamous Cell Carcinoma NSCC.
时间窗: through study completion, an average of 1 year
To establish the ability of 11C-Gln PET imaging to detect tumors in patients with (HNSCC) Head and Neck Squamous Cell Carcinoma NSCC.
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点