[18F]Fluoro-PEG-folate PET/CT Imaging in Epithelial Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Tolerability of the [18F]fluoro-PEG-folate PET tracer
研究概览
简要总结
The pre-operative assessment of intra-abdominal tumor load in patients with epithelial ovarian cancer (EOC) remains unreliable with standard imaging modalities. The use of tumor targeted imaging, such as folate receptor (FR)-targeted positron emission tomography (PET) imaging could aid in the preoperative assessment of metastatic tumor load.
This study aims to evaluate the safety and tolerability, and pharmacokinetics of the [18F]fluoro-PEG-folate PET tracer and to assess the sensitivity and specificity of a [18F]fluoro-PEG-folate PET/CT scan for the preoperative detection of intra-abdominal metastatic lesions in patients with advanced stage epithelial ovarian cancer.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with radiologically FIGO stage IIIB/IIIC EOC based on the conventional CT scan who are:
- •scheduled to undergo primary cytoreductive surgery and
- •in whom EOC is histologically proven, or
- •in whom EOC is cytologically suspected and a serum CA125/CEA ratio > 25 is found
- •treated with neoadjuvant chemotherapy (NACT) and are scheduled to undergo interval cytoreductive surgery and
- •in whom EOC is histologically proven, or
- •in whom EOC is cytologically suspected and a serum CA125/CEA ratio > 25 was found before NACT
- •and with radiologically FIGO stage IIIB/IIIC EOC based on the response evaluation CT scan after NACT
排除标准
- •Women younger than 30 years of age (in accordance with the guidelines of the Netherlands Commission on Radiation Dosimetry [23], as the total radiation dose will be 7.2 mSv)
- •Patients who previously underwent primary laparotomy and in whom complete or optimal cytoreduction was not considered feasible.
- •Contraindication for PET (pregnancy, lactating or severe claustrophobia)
- •Thrombocytopenia (platelet count < 100 x 10^9/L) and/or INR > 2
- •Impaired renal function (defined as eGFR < 50 mL/1.73 m2)
- •Impaired liver function (ALT, AST or total bilirubin > 3x upper limit of normal)
- •Clinically significant abnormalities on ECG and/or clinically laboratory test
- •Inability to tolerate lying supine for the duration of a PET/CT examination (~110 minutes)
- •Patients with concomitant malignancy (except basal cell carcinoma of the skin) or any condition that in the opinion of the investigators could potentially jeopardize the health status of the patient
- •Patients not able to comply with the study procedures
- •Patients who did not give informed consent
结局指标
主要结局
Tolerability of the [18F]fluoro-PEG-folate PET tracer
时间窗: From administration up to two hours after administration
To assess the tolerability of the \[18F\]fluoro-PEG-folate PET tracer vital signs will be recorded every 15 minutes starting directly before administration and continued up to two hours after dosing. The endpoint for this study is the number of patients whose vital signs stayed within a normal range of their baseline.
Pharmacokinetic distribution of the [18F]fluoro-PEG-folate tracer
时间窗: At regular intervals up to 90 minutes post injection of the tracer.
Blood samples will be collected to determine the pharmacokinetic distribution of the tracer.
Arterial plasma input curve of the [18F]fluoro-PEG-folate tracer
时间窗: At regular intervals up to 90 minutes post injection of the tracer.
Blood samples will be collected to determine the arterial plasma input curve of the tracer.
Safety of the [18F]fluoro-PEG-folate PET tracer
时间窗: Up to six weeks after the injection of the tracer.
Total number of AEs and SAEs that occur during the observation period.
次要结局
- Sensitivity and specificity(Up to 6 weeks after the FR-targeted PET/CT scan.)
研究者
Lioe-Fee de Geus-Oei, MD PhD
Principal Investigator
Leiden University Medical Center