A Cancer Research UK Phase II Trial to Compare [11C]Choline and [18F]Choline Each Given as a Single Administration Via Intravenous Injection for Imaging Patients With Metastatic Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Identification of a true 5% difference in lesion detection using 18F-fluoromethylcholine versus C-11 choline
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) and computed tomography (CT) imaging, may help find and diagnose metastatic prostate cancer.
PURPOSE: This phase II trial is studying the side effects of C-11 choline and 18F-fluoromethylcholine and to see how well they work when used in PET and CT imaging in patients with metastatic prostate cancer.
详细描述
OBJECTIVES:
- To compare C-11 choline to 18F-fluoromethylcholine using positron emission tomography and computed tomography imaging in their ability to detect metastatic prostate cancer.
- To compare the best early-phase (immediate) scanning of the two agents against the late-phase (one-hour delayed) 18F-fluoromethylcholine scanning in their ability to detect metastatic prostate cancer.
- To assess the safety of C-11 choline and 18F-fluoromethylcholine in these patients.
OUTLINE: Patients receive C-11 choline IV followed by a 10-minute dynamic positron emission tomography (PET) scan over the pelvis and then 5-minute scans at each bed position, from the pelvis to the base of the skull, (up to a maximum of 7 additional bed positions) lasting up to 45 minutes on day 1. Beginning 3 hours later, patients receive 18F-fluoromethylcholine IV followed by the same scanning protocol above lasting approximately 45 minutes. An additional 1-hour delayed PET-computed tomography (CT) scanning is then performed, which involves a 5-minute scan at each bed position from the pelvis to the base of the skull (up to a maximum of 7 bed positions) with 18F-fluoromethylcholine, lasting approximately 35 minutes. Patients then undergo treatment as per the normal standard of care following participation in this trial.
After completion of study treatment, patients are followed between 3-7 days.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed prostate cancer
- •At least 4 metastatic lesions identified by conventional imaging with bone scintigraphy
- •Treatment-naive disease
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Life expectancy ≥ 12 weeks
- •Hemoglobin ≥ 9.0 g/dL
- •Platelet count ≥ 100 x 10^9/L
- •Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN if due to tumor)
- •Fertile patients must use two forms of effective contraception 2 weeks prior to, during, and for 6 months after completion of study therapy
- •None of the following conditions that would prevent compliance with the study protocol:
- •High levels of pain/discomfort
- •Urinary incontinence
- •No history of recent significant cardiac arrhythmia
- •No concurrent congestive heart failure or prior history of NYHA class III-IV cardiac disease
- •No other condition that, in the investigator's opinion, would not make the patient a good candidate for the clinical trial
- •PRIOR CONCURRENT THERAPY:
- •No prior radiotherapy, hormone therapy, chemotherapy, endocrine therapy, or immunotherapy for the treatment of prostate cancer
- •No major thoracic and/or abdominal surgery from which the patient has not yet recovered
- •No concurrent anticancer therapy
- •No concurrent hormone therapy
- •No concurrent participation or planning to participate in another interventional clinical trial
- •Concurrent participation in an observational trial allowed
- •No other concurrent investigational drugs
排除标准
- 未提供
结局指标
主要结局
Identification of a true 5% difference in lesion detection using 18F-fluoromethylcholine versus C-11 choline
次要结局
- Identification of a true 5% difference in lesion detection between the best early-phase scanning, using either the 18F-fluoromethylcholine and C-11 choline, and late-phase scanning using 18F-fluoromethylcholine
- Causality of each adverse event to C-11 choline and 18F-fluoromethylcholine and adverse event severity according to NCI CTCAE version 4.0