A Pilot, Phase II , Open Label, Nonrandomized, Multi- Center Study of [F 18]HX4 Positron Emission Tomography (PET) to Detect Hypoxia in Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Reproducibility of [F18]HX4 PET Imaging in Measuring Hypoxia in Tumors
研究概览
简要总结
This pilot phase II study is designed as a test and retest study to investigate [F 18]HX4 as a reliable non-invasive PET imaging marker for detection of tumor hypoxia regions and to establish a threshold for [F 18]HX4 uptake in the tumor. The study will evaluate the relationship between hypoxia biomarkers (HIF1α and CA-IX) by immunohistochemistry (IHC) and tumor uptake of [F 18]HX4 by PET imaging.
详细描述
A Pilot Phase II Study
The primary objectives for this study are:
- To test the reproducibility of [F-18] HX-4 uptake in tumors by imaging the same patient on sequential days in a test-retest protocol
- To test and confirm the relationship between hypoxia in tumors measured by hypoxia related biomarkers (HIF1α and CA-IX) with immunohistochemistry (IHC) and regional [F-18 HX-4] uptake in tumors with PET/CT.
The secondary objectives for this study are:
- To continue safety evaluation by the collection of safety data from all patients
- To establish the threshold for hypoxia uptake in [F- 18]HX4 PET imaging
- To collect data to test [F-18]HX4 PET imaging as a predictor of response in a subgroup of patients receiving treatment
- To gain experience with [F-18]HX4 PET/CT in order to improve the study design to conduct future studies
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient is >18 years and male or female of any race / ethnicity
- •Patient or patient's legally acceptable representative provides written informed consent and is willing to comply with protocol procedures
- •Patient must have histopathologically confirmed head/neck, lung, liver, rectal or cervical cancer with tumor size ≥ 3cm
- •Patient has tumor tissue samples available before treatment for future immunohistochemistry biomarker tests (HIF1alpha and CA-IX)
- •Patient is scheduled to have or already had a clinical [F 18]FDG PET/CT scan recommended to be within 14 days of the first pre-treatment [F 18]HX4 PET/CT scan and have no treatment intervention in between these two scans
- •Patient is scheduled or is intended to be scheduled to receive chemotherapy, radiation or chemoradiotherapy treatment(s) after the pre-treatment [F 18]HX4 PET/CT and [F 18]FDG PET/CT scans for his/her cancer care
- •Patient must have hepatic and renal functions as defined by laboratory results within the following ranges:
- •Total bilirubin within 2 times institutional upper limit of normal
- •AST (SGOT) and ALT (SGPT) ≤ 2.5 times institutional upper limits of normal
- •Serum creatinine ≤ 2.5 times institutional limit of normal
- •BUN within 2 times institutional upper limit of normal
排除标准
- •Patient is not capable of complying with study procedures
- •Female patient is pregnant or nursing
- •o Exclude the possibility of pregnancy by one of the following:
- •Confirming in medical history that the patient is post-menopausal for a minimum of one year, or surgically sterile
- •Confirming the patient is using one of the following methods of birth control for a minimum of one month prior to entry into this study: IUD, oral contraceptives, Depo-Provera, or Norplant
- •Confirming a negative urine dipstick test taken the morning of but before receiving [F 18]HX4
- •Patient has been involved in an investigative, radioactive research procedure within 7 days and during the study participation period
- •Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data
研究组 & 干预措施
[F 18]HX4
[F18]HX4, 10 mCi, is administered in a single intravenous bolus injection, followed by a saline flush.
干预措施: [F 18]HX4 (Drug)
结局指标
主要结局
Reproducibility of [F18]HX4 PET Imaging in Measuring Hypoxia in Tumors
时间窗: Time between 1st and 2nd scan was 1 to 6 days
Primary tumor uptake of \[F 18\]HX4 was measured on PET images by onsite radiologist or nuclear medicine physician for 1st and 2nd PET scans. Values measured were: SUV (Standard Uptake Value), SUV Max (Maximum standard uptake value), SUV Mean (Mean standard uptake value), and T/B ratio (Tumor to background ratio). Pearson's correlation coefficient was calculated for each of the parameter.
次要结局
未报告次要终点