A Study to Assess the Diagnostic Performance of 18F-Thretide PET/CT in Men With Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- detection rate at the lesion level
研究概览
简要总结
This study evaluates the diagnostic performance and safety of 18F-Thretide PET/CT in patients with biopsy proven prostate cancer who has no any form of therapy against prostate caner or suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.
详细描述
Prostate-specific membrane antigen (PSMA) is overexpressed in most cases of prostate cancer and is potentially associated with metastasis and progression of prostate cancer. Compared with 68Ga, the PET radionuclide 18F exhibits several advantages. 18F-Thretide (18F-labeled PSMA ligand) has been studied for preclinical evaluation and Pilot Clinical Study. This study evaluates the diagnostic performance and safety of 18F-Thretide PET/CT in patients with with biopsy proven prostate cancer who has no any form of therapy against prostate caner or suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male ≥ 18 years of age;
- •For patients with newly diagnosed prostate cancer : (1) adult patients with PCa confirmed by biopsy; (2) no any form of therapy against PCa within last three months; (3) planned surgical treatment;
- •For patients with suspected recurrence of prostate cancer: (1)Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy; (2)Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of: Post-radical prostatectomy: Detectable or rising PSA level ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL ; or Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir;
- •Life expectancy ≥3 months as determined by the investigator;
- •Able and willing to provide informed consent and comply with protocol requirements.
排除标准
- •Known allergic history to fluoride 18F-Thretide injection and/or 99mTc-MDP or its excipients;
- •Patients who cannot tolerate intravenous administration (such as a history of needle sickness or blood sickness);
- •Those who are not suitable for or unable to complete PET or other imaging examinations due to special reasons, including claustrophobia and radiophobia, etc.
- •Practitioners requiring prolonged exposure to radioactive conditions;
- •Serious diseases of the heart, kidney, lung, vascular, nervous and psychiatric systems, immune deficiency diseases and hepatitis/cirrhosis;
- •Have been diagnosed with clinical recurrence of prostate cancer;
- •Patients receiving ADT treatment or chemotherapy;
- •Patients who participated in clinical trials of radiopharmaceuticals within the previous 1 year;
- •Participated in other interventional clinical trials within 1 month prior to screening;
- •There are other conditions that the researcher considers inappropriate to participate in this study.
研究组 & 干预措施
18F-Thretide Injection
7±1 mCi (259±37 MBq) IV injection of 18F-Thretide
干预措施: A single dose of 7±1 mCi (259±37 MBq) IV injection of 18F-Thretide (Drug)
结局指标
主要结局
detection rate at the lesion level
时间窗: Within 60 days following 18F-Thretide PET/CT
The difference in detection rate of 18F-Thretide PET/CT at the lesion level compared with MRI, CT, or bone scanning. Within 60 days following 18F-Thretide PET/CT, either MRI, CT, or bone scan will be performed
positive predictive value
时间窗: Within 60 days following 18F-Thretide PET/CT
The positive predictive value (PPV) of 18F-Thretide PET/CT in the diagnosis of prostate cancer compared with the composite truth standard. Within 60 days following 18F-Thretide PET/CT, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the 18F-Thretide-suspected lesion(s) will be performed.
Safety evaluation
时间窗: Within 7 days following 18F-Thretide PET/CT
The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
sensitivity and specificity
时间窗: Within 60 days following 18F-Thretide PET/CT
The sensitivity and specificity of 18F-Thretide PET/CT in the diagnosis of prostate cancer compared with the composite truth standard. Within 60 days following 18F-Thretide PET/CT, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the 18F-Thretide-suspected lesion(s) will be performed
detection rate at the patient level
时间窗: Within 60 days following 18F-Thretide PET/CT
The Difference in detection rate of 18F-Thretide PET/CT at the patient level compared with MRI, CT, or bone scanning. Within 60 days following 18F-Thretide PET/CT imaging, either MRI, CT, or bone scanning will be performed.
Correct detection rate
时间窗: Within 60 days following 18F-Thretide PET/CT
The correct detection rate (CDR) of 18F-Thretide PET/CT imaging in the diagnosis of prostate cancer compared with the composite truth standard. Within 60 days following 18F-Thretide PET/CT, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the 18F-Thretide-suspected lesion(s) will be performed
次要结局
未报告次要终点
研究者
Weibing Miao, PhD
Director of Nuclear Medicine Department
First Affiliated Hospital of Fujian Medical University