NCT02876991Unknown不适用
Evaluation of Sodium Fluoride PET in the Identification of Bone Metastases in Patients Having Undergone a Choline PET for Occult Recurrence of Prostatic Adenocarcinoma
Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2016年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Percentage of patients with choline PET negative and sodium fluoride PET positive for bone extension (metastasis)
研究概览
简要总结
The purpose is to evaluate if sodium fluoride PET in patients having already undergone a choline PET negative for bone extension (non-metastatic status) modifies the status of patients concerning the existence or not of bone metastases.
Secondary purposes are:
- To evaluate if detection of bone metastasis by sodium fluoride PET, not detected by choline PET, leads to change of treatment
- To evaluate inter-technique concordance (choline vs sodium fluoride PET) of results (metastatic status and number of lesions)
- To evaluate the inter-judge concordance of interpretation of sodium fluoride PET
- To study the discordance of metastatic status of 2 techniques.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate adenocarcinoma regardless of Gleason score
- •Patients having undergone radical treatment (prostatectomy or radiotherapy (external or brachytherapy) +/- conco-adjuvant hormonal therapy)
- •Level of Prostate Specific Antigen (PSA) indicating recurrence: PSA > 0.2 ng/ml in case of prostatectomy (in 2 consecutive tests in less than 1 month) or elevation of PSA of at least 2 ng/ml above nadir in case of radiotherapy or brachytherapy (in 2 consecutive tests in less than 1 month)
- •Negative conventional assessment (thoracic-abdominal-pelvic scanner and bone scintigraphy) during 6 weeks before inclusion
- •Patient having undergone a choline PET at CHRU Nancy
- •Signed informed consent
- •Affiliation to French social security
- •Absence of contraindications to sodium fluoride PET
排除标准
- •Refusal or impossibility of informed consent
- •Patient incapable to consent
- •Patient deprived of liberty
- •Person under legal protection
- •Person in life-and-death emergency
- •Drug addiction, alcoholism, psychological problems affecting patient compliance
- •Severe co-morbidities
- •Modification of hormonal therapy (if applicable) during 3 months before inclusion
- •Renal insufficiency (creatinine clearance < 60 ml/min) detected during last assessment before inclusion
- •Other progressive tumors (recovered cancers are not a non-inclusion criteria)
结局指标
主要结局
Percentage of patients with choline PET negative and sodium fluoride PET positive for bone extension (metastasis)
时间窗: Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks)
次要结局
- Inter-strategy concordance of diagnosis evaluated by kappa coefficient(Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks))
- Metastatic status and number of lesions detected respectively by sodium fluoride PET and choline PET(Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks))
- Metastatic status and number of lesions identified by 3 medical doctors of 2 different centres in sodium fluoride PET(Execution of sodium fluoride PET (from baseline up to 4 weeks))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Sodium Fluoride Imaging of Abdominal Aortic AneurysmsAbdominal Aortic AneurysmNCT02229006University of Edinburgh96
终止
不适用
Sodium Fluoride PET/CT for the Evaluation of Skeletal CancerBone CancerNCT01541358Stanford University2
已完成
2 期
F-18 Sodium Fluoride in Prostate CancerProstate NeoplasmNCT01240551National Cancer Institute (NCI)60
招募中
早期 1 期
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)RadiotracerCholesterolHypertensionNCT04546126Benjamin Viglianti24
已完成
3 期
Clinical Value of FEC-PET Combined With Endorectal MRI for Pre-therapeutic Staging of Prostate CancerProstate CancerNCT00520546Dr. Markus Hartenbach44