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
- 2
- 主要终点
- Biodistribution of radioactivity of 99mTc DB4 by gamma-camera imaging
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Biodistribution of radioactivity of 99mTc DB4 by gamma-camera imaging
Pharmacokinetics of 99mTc DB4 in blood and urine and assessment of decline over 6 hours
Causality of each adverse events as assessed by NCI CTCAE v. 3.0
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 (2)
Loading locations...
相似试验
尚未招募
不适用
Clinical Application of 99mTc-FDPH46 SPECT/CT Imaging in Malignant Solid Tumor: a Prospective Exploratory StudyMalignant TumorsSolid Tumor MalignancyNCT06753513Zhejiang University20
已完成
2 期
A Single Center Study to Establish the Imaging Protocol of 99mTc-EC-DG in Evaluating the Presence and Severity of Coronary Artery Disease (CAD)Coronary Artery DiseaseNCT01778218Cell>Point LLC2
已完成
不适用
A Study of 99m Tc Pertechnetate Produced in High Energy Cyclotron in Patients With Thyroid Scan IndicationAutoimmune Thyroid DiseaseCongenital HypothyroidismNCT02307175Centre de recherche du Centre hospitalier universitaire de Sherbrooke30
Unknown
不适用
The Role of the Novel 99mTc-NC100692 Tracer in Patients at High Risk or Known Breast CancerTumor AngiogenesisBreast CancerNCT01503697Tel-Aviv Sourasky Medical Center75
撤回
2 期
Comparing PET-CT Using C-11 Choline and 18F-Fluoromethylcholine in Patients With Metastatic Prostate CancerProstate CancerNCT01132599Cancer Research UK