A Prospective Study Comparing the Diagnostic Accuracy of Bone SPECT-CT, Choline-PET-CT, PSMA-PET-CT, NaF-PET-CT and WB-MRI in the Detection of Prostate Cancer Bone Metastases
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
An improved diagnosis of bone metastases in prostate cancer patients can have a significant impact on treatment strategy and probably survival as well.
The primary purpose of the project is to determine the diagnostic accuracy of bone SPECT-CT, choline-PET-CT, PSMA-PET-CT, NaF-PET-CT and Whole-body MRI in the diagnosis of bone metastases in prostate cancer patients.
详细描述
The project is a prospective diagnostic test accuracy study. The project takes place at Herlev Hospital and is a collaboration between the Department of Radiology and the Department of Clinical Physiology and Nuclear Medicine.
The investigators want to include 300 prostate cancer patients referred to our standard diagnostic imaging (NaF-PET-CT scan) by the clinicians.
In addition to the standard diagnostic imaging (NaF-PET-CT-scan), two project will be performed on all participants. The project has three arms with the following scanning combinations:
A) Whole-body MRI + SPECT-CT B) Whole-body MRI + Cholin-PET-CT C) Whole-body MRI + PSMA-PET-CT The recruitment of project participants takes place on the day when the patients are undergoing a NaF-PET-CT scan in the course of regular clinical practice at our institution.
All readers are experienced radiologists or specialists in nuclear medicine. Patient identification on each scan will be anonymized and the reader will not have access to clinical and biochemical information or previous imaging studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •A subject will be eligible for project participation if he meets all of the following criteria:
- •Is either 1) a newly diagnosed prostate cancer patient in clinical suspicion of bone metastases or 2) a previously diagnosed prostate cancer patient in clinical suspicion of progression in the form of bone metastases. The subject must have been referred to the standard diagnostic imaging (18F-NaF-PET-CT) at our institution for bone metastases.
- •The prostate cancer diagnosis must be biopsy-proven
- •The subject is willing and able to comply with the protocol as judged by the investigator
排除标准
- •A subject will be excluded from the protocol if he meets one or more of the following criteria:
- •Has prior malignancy, except for adequately treated basal cell or squamous cell skin cancer
- •Has pacemaker or implanted devices (eg. cardiac valves, neurostimulator or insulin pump) that cannot be removed, metal clips/metal prostheses from surgery that are not MRI compatible or metallic foreign bodies in the eye (MRI exclusion criteria)
- •Has any condition that places the subject at an unacceptable risk if he undergoes a diagnostic CT-scan (e.g. history of severe allergic reaction to the contrast agent).
- •Has severe obesity (>195 kg is the weight limit for the scanner table)
- •Has severe claustrophobia
研究组 & 干预措施
SPECT-CT
The participants will undergo two project scans: WB-MRI and SPECT-CT
干预措施: WB-MRI (Diagnostic Test)
SPECT-CT
The participants will undergo two project scans: WB-MRI and SPECT-CT
干预措施: SPECT-CT (Diagnostic Test)
Cholin-PET-CT
The participants will undergo two project scans: WB-MRI and Cholin-PET-CT
干预措施: Cholin-PET-CT (Diagnostic Test)
Cholin-PET-CT
The participants will undergo two project scans: WB-MRI and Cholin-PET-CT
干预措施: WB-MRI (Diagnostic Test)
PSMA-PET-CT
The participants will undergo two project scans: WB-MRI and PSMA-PET-CT
干预措施: WB-MRI (Diagnostic Test)
PSMA-PET-CT
The participants will undergo two project scans: WB-MRI and PSMA-PET-CT
干预措施: PSMA-PET-CT (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy
时间窗: The two project scans will be performed within a maximum of 30 days from the performance of the NaF-PET-CT scan
Sensitivity and specificity
次要结局
未报告次要终点
研究者
Eva Dyrberg Mortensen
MD, Phd-student
Herlev Hospital