NCT00989105终止1 期
A Cancer Research UK Phase I Trial of 99mTc Demobesin-4 (a Diagnostic Radiopharmaceutical) Given Once Via Bolus Intravenous Injection for Imaging of Prostate Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Causality of each adverse events as assessed by NCI CTCAE v. 3.0
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as technetium Tc 99m demobesin-4 followed by single-photon emission computer tomography, CT scan, and MRI, may help find prostate cancer and learn the extent of disease.
PURPOSE: This phase I trial is studying the side effects of technetium Tc 99m demobesin-4 and to see how well it works for imaging procedures in patients with prostate cancer.
详细描述
OBJECTIVES:
Primary
- To assess the safety of technetium Tc 99m (^99mTc) demobesin-4 (DB4) in patients with prostate cancer.
- To assess the biodistribution of ^99mTc DB4 in these patients.
- To assess the pharmacokinetics of ^99mTc DB4 in these patients.
Secondary
- To assess the performance of ^99mTc DB4 in detecting metastatic spread of prostate cancer in these patients.
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 meeting 1 of the following criteria:
- •Disease confined to the prostate that is to be treated with radical prostatectomy after imaging
- •Locally advanced disease that is to be treated with radiotherapy
- •Patients must agree to undergo surgical pelvic lymph node staging to assist with determination of radiation fields
- •Metastatic disease at initial diagnosis or recurrent or progressive disease
- •Patients receive standard of care
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Neutrophils ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9.0 g/dL
- •Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Serum creatinine ≤ 1.5 times ULN
- •Must be registered with the Cancer Research UK Drug Development Office
- •Capable of cooperating with imaging procedure and follow-up
- •Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- •Not at high medical risk because of non-malignant systemic disease, including active uncontrolled infection
- •No history of recent significant cardiac arrhythmia
- •No prior NYHA class III-IV cardiac disease or concurrent congestive heart failure
- •No other condition that, in the Investigator's opinion, would not make the patient a good candidate for the clinical trial
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No chemotherapy or radiotherapy prior to or within 2 weeks of study therapy
- •No prior major thoracic and/or abdominal surgery from which the patient has not yet recovered
- •No other concurrent investigational drugs
- •Concurrent anticancer therapy allowed
排除标准
- 未提供
结局指标
主要结局
Causality of each adverse events as assessed by NCI CTCAE v. 3.0
Pharmacokinetics of 99mTc DB4 in blood and urine and assessment of decline over 6 hours
Biodistribution of radioactivity of 99mTc DB4 by gamma-camera imaging
次要结局
- Performance of 99mTc DB4 gamma-camera imaging compared with conventional imaging (CT scan and/or MRI)
- Levels of expression in gastrin-releasing peptide in prostate tumor samples and lymph node specimens
研究者
研究点 (1)
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