Clinical Evaluation of the New Hypoxia Imaging Agent HX4
关键词
抽象
描述
Objective of the study
The aim of this study is to:
- evaluate a hypoxia imaging agent, HX4, in patients with solitary tumors (i.e., locally advanced head and neck cancer)
- gain information on bio-distribution of [F-18]HX4
- compare the PET images of [F-18] FMISO to [F-18]HX4 for resolution, signal to background ratio, and tumor/blood ratio
日期
| 最后验证: | 08/31/2012 |
| 首次提交: | 08/13/2009 |
| 提交的预估入学人数: | 09/28/2010 |
| 首次发布: | 09/30/2010 |
| 上次提交的更新: | 09/19/2012 |
| 最近更新发布: | 09/24/2012 |
| 实际学习开始日期: | 05/31/2009 |
| 预计主要完成日期: | 12/31/2009 |
| 预计完成日期: | 04/30/2010 |
状况或疾病
干预/治疗
Drug: 10 mCi FMISO
Drug: 10 mCi HX4
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: 10 mCi HX4 Patient will be injected with [F-18] FMISO | Drug: 10 mCi HX4 10 mCi [F18] HX4 and 10 mCi [F-18] FMISO within 7 days of each other regardless of sequence |
| Active Comparator: 10 mCi FMISO Patient will be injected with [F-18] HX4 | Drug: 10 mCi FMISO 10 mCi [F18] HX4 and 10 mCi [F-18] FMISO within 7 days of each other regardless of sequence |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Patient may be male or female and of any race / ethnicity - Patient is > 18 years old at the time of investigational product administration - Patient or patient's legally acceptable representative provides written informed consent - Patient is capable of complying with study procedures - Patient is capable of communicating with study personnel - Patient must have histologically confirmed stage III, or IV squamous cell carcinoma of the head and neck whose primary origin was from the oral cavity, oropharynx, hypopharynx, or larynx. - According to the Karnofsky Performance Status Scale, the patient has a value of ≥ 60% at time of screening - Patient must have normal organ and renal function as defined: - total bilirubin within normal institutional limits - AST(SGOT)/ALT(SGPT) less than or equal to 2.5 x institutional upper limits of normal - creatinine within normal institutional limits - BUN within normal institutional limits - PT and PTT < 2.0 x institutional upper limits of normal Exclusion Criteria: - Patient is younger than 18 years old at the time of investigational product administration - Female patient is pregnant or has a positive serum pregnancy test - Patient is unable to remain still for duration of imaging procedure - Patient has a history of significant renal disease - Patient has previously received [F-18]HX4 at any time, or any other investigational product in the past thirty days. - Patient has been involved in an investigative, radioactive research procedure within the past year - Inadequate tumor sites or volume to allow for biopsy - Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete and good quality data |
结果
主要结果指标
1. Efficacy of a hypoxia imaging agent, HX4, in patients with solitary tumors (i.e., locally advanced head and neck cancer) [6 months]
次要成果指标
1. Resolution, signal to background ratio, and tumor/blood ratio of PET images with [F-18] FMISO and [F-18]HX4 [6 months]
