HERPET: A Mechanistic Non-Invasive Imaging Study of HER2 Expression in Breast Cancer Using [18F]GE-226 Positron Emission Tomography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Tumoral uptake of [18F]GE-226 in patients with breast cancer measured using semi-quantitative parameters
研究概览
简要总结
This mechanistic study will be the first study to assess the efficacy of [18F]GE-226 to target HER2 expression in patients with metastatic breast cancer. The study will establish the pharmacokinetics of [18F]GE-226 and the optimum time-point for performing static scans in this patient population.
详细描述
Objectives
Primary:
- To determine the uptake in tumour lesions and normal tissue of [18F]GE-226 and compare the difference between patients with HER2 positive and HER2 negative lesions. Uptake will be quantified by semi-quantitative (SUV, AUC) and fully quantitative parameters (Ki in the case of irreversible uptake, and binding potential in the case of reversible uptake)
- To determine the optimal imaging time point for [18F]GE-226
Secondary:
- To determine the safety and toxicity of [18F]GE-226 PET in humans
- To determine if [18F]GE-226 can distinguish between HER2 amplified and HER2 non-amplified breast tumours
- To determine the metabolism of [18F]GE-226 in human subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with a histological diagnosis of breast cancer with known HER2 status ((8 positive and 8 negative).
- •Written informed consent prior to admission in the study.
- •Target lesion diameter of ≥15mm that has not been previously irradiated.
- •Female patients aged ≥ 18 years of age.
- •For all patients: histologically confirmed locally advanced/metastatic breast cancer with a biopsy within the last 12 months confirming HER2 status by either immunohistochemistry (IHC), Silver In Situ Hybridization (SISH) or Fluorescent In Situ Hybridization (FISH).
- •ECOG performance status 0-2
- •Negative urine pregnancy test (within 2 hours prior to injection of imaging agent) in women of child bearing age and willingness to use contraception (barrier, abstinence, non-hormonal) for 3 weeks after injection of [18F]GE-226
- •Life expectancy > 3 months
- •Adequate organ function as defined by
- •WBC≥3.0 x 109/L
- •PLT≥80 x 109/L
- •Serum creatinine ≤1.4mg/dl
- •SGOT and SGPT ≤2 x ULN
- •Total bilirubin ≤ 2 x ULN or 3.0 mg/dl in patients with Gilbert's syndrome
- •Patients must have been appropriately staged using FDG-PET within 42 days of study entry and additional imaging according to local standard of care
排除标准
- •Pregnant or lactating women.
- •History of cardiac disease (myocardial infarction, arrhythmias requiring therapy, symptomatic valvular disease, cardiomyopathy, or pericarditis).
- •Evidence of significant medical condition or laboratory finding which, in the opinion of the Investigator, makes it undesirable for the patient to participate in the trial.
- •Participants with severe claustrophobia or who are unable to lie flat or fit into the scanner (≥350 lbs (160 Kg)).
- •Prior use within 14 days of enrolment or concurrent therapy with any other investigational agent.
- •Patients classified as radiation workers
- •Patients on therapeutic doses of anticoagulants, or with a raised prothrombin time
研究组 & 干预措施
HER2 negative metastatic breast cancer
8 HER2 negative patients (determined using the most recent biopsy) will be recruited. Dynamic [18F]GE-226 PET imaging over 90 minutes, radial artery sampling will be performed to establish the pharmacokinetic profile of [18F]GE-226 and hence determine the optimal imaging time point for [18F]GE-226 PET scans. Tumour uptake in individual metastases (and the target lesion) will be reported. Uptake will be compared between HER2 positive and negative tumours.
干预措施: [18F]GE-226 (Radiation)
HER2 positive metastatic breast cancer
8 HER2 positive patients (determined using the most recent biopsy) will be recruited. Dynamic [18F]GE-226 PET imaging over 90 minutes, radial artery sampling will be performed to establish the pharmacokinetic profile of [18F]GE-226 and hence determine the optimal imaging time point for [18F]GE-226 PET scans. Tumour uptake in individual metastases (and the target lesion) will be reported. Uptake will be compared between HER2 positive and negative tumours.
干预措施: [18F]GE-226 (Radiation)
结局指标
主要结局
Tumoral uptake of [18F]GE-226 in patients with breast cancer measured using semi-quantitative parameters
时间窗: 24 months
Tumoral uptake of \[18F\]GE-226 in patients with HER2 positive and HER2 negative breast cancer measured using SUV and AUC.
Tumoral uptake of [18F]GE-226 in patients with breast cancer measured using fully quantitative parameters
时间窗: 24 months
Tumoral uptake of \[18F\]GE-226 in patients with HER2 positive and HER2 negative breast cancer measured using Ki in the case or irreversible uptake, and binding potential in the case of reversible uptake.
次要结局
- Adverse events of [18F]GE-226 injection(0 hour, 48 hours)
- Serum biochemistry change from baseline measurement(0 hour, 48 hours)
- Haematology change from baseline measurement(0 hour, 48 hours)
- Immunology change from baseline measurement(0 hour, 48 hours)
- Urine change from baseline measurement(0 hour, 48 hours)
- EEG change from baseline measurement(0 hour, 48 hours)