68Ga-NeoBOMB1 and 68Ga-PSMA R2 PET/MRI in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Number of Lesions Detected by Investigational Imaging Agent
研究概览
简要总结
This phase II trial studies how well gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 positron emission tomography (PET)/magnetic resonance imaging (MRI) work in diagnosing participants with prostate cancer that has come back. Diagnostic procedures, such as gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 PET/MRI, may help find and diagnose prostate cancer and find out how far the disease has spread.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate gallium Ga 68 DOTA-NeoBOMB1 (68Ga-NeoBOMB1) and gallium Ga 68 PSMA-R2 (68Ga-PSMA R2) PET/MRI for detection of recurrent prostate cancer after initial therapy in patients meeting the criterion of biochemical recurrence.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive gallium Ga 68 DOTA-NeoBOMB1 intravenously (IV) and 45 minutes later, undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 PSMA-R2 IV then undergo PET/MRI 45-60 minutes later.
ARM II: Participants receive gallium Ga 68 PSMA-R2 IV and 45-60 minutes later undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 DOTA-NeoBOMB1 IV then undergo PET/MRI 45 minutes later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Biopsy proven prostate adenocarcinoma.
- •Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
- •a. Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation.
- •(i) PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical prostatectomy.
- •(ii) Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL).
- •b. Post-radiation therapy ? American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition.
- •(i) A rise of PSA measurement of 2 or more ng/mL over the nadir.
- •Able to provide written consent.
- •Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent).
排除标准
- •Inability to lie still for the entire imaging time.
- •Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).
- •Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
- •Known allergy, hypersensitivity, or intolerance to the investigational product or its excipients.
- •Metallic implants (contraindicated for magnetic resonance imaging [MRI]).
研究组 & 干预措施
Arm I (Ga68-NeoBOMB1 and Ga68 PSMA-R2
Participants receive gallium Ga 68 DOTA-NeoBOMB1 IV and 45 minutes later, undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 PSMA-R2 IV then undergo PET/MRI 45-60 minutes later.
干预措施: Gallium Ga 68 DOTA-NeoBOMB1 (Drug)
Arm I (Ga68-NeoBOMB1 and Ga68 PSMA-R2
Participants receive gallium Ga 68 DOTA-NeoBOMB1 IV and 45 minutes later, undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 PSMA-R2 IV then undergo PET/MRI 45-60 minutes later.
干预措施: Gallium Ga 68 PSMA-R2 (Device)
Arm II (Ga68 PSMA-R2 and Ga 68-NeoBOMB1)
Participants receive gallium Ga 68 PSMA-R2 IV and 45-60 minutes later undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 DOTA-NeoBOMB1 IV then undergo PET/MRI 45 minutes later.
干预措施: Gallium Ga 68 DOTA-NeoBOMB1 (Drug)
Arm II (Ga68 PSMA-R2 and Ga 68-NeoBOMB1)
Participants receive gallium Ga 68 PSMA-R2 IV and 45-60 minutes later undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 DOTA-NeoBOMB1 IV then undergo PET/MRI 45 minutes later.
干预措施: Gallium Ga 68 PSMA-R2 (Device)
结局指标
主要结局
Number of Lesions Detected by Investigational Imaging Agent
时间窗: Up to approximately 2 hours to complete each scan
The number of lesions detected on Ga- NeoBOMB1 positron emission tomography (PET)/magnetic resonance imaging (MRI), Ga PSMA R2 PET/MRI, and conventional MR will be compared.
次要结局
- Number of Detected Lesions Confirmed to be Malignant for Each Imaging Method(At 1 year post-scan follow-up)
研究者
Andrei Iagaru
Professor of Radiology (Nuclear Medicine)
Stanford University