Digital PET/CT Using [Ga-68]PSMA vs. [F-18]NaF for Evaluation of Osseous Metastatic Involvement in Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Uptake of [Ga-68]PSMA as measured by lesion by lesion analysis
研究概览
简要总结
The purpose of this study is to evaluate a radioactive diagnostic study drug, which is called Gallium-68 Prostate Specific Membrane Antigen ([Ga-68]PSMA) for detection of bone metastasis in patients with prostate cancer.
For imaging the investigators will use a FDA approved imaging technology, digital Positron Emission Tomography (PET/CT). The investigators would like to know if digital PET/CT using [Ga-68]PSMA provides accurate information about the extent of bone metastases.
Therefore, the investigators will compare[Ga-68]PSMA PET/CT with Flourine-18 [F-18] Sodium Fluoride (NaF), which is a high resolution bone scan. [F-18]NaF is FDA approved and the reference standard for evaluating the presence of bone metastases.[Ga-68]PSMA is an investigational (experimental) drug that works by binding to Prostate Specific Membrane Antigen, which is overexpressed in prostate cancer. [Ga-68]PSMA is experimental because it is not approved by the Food and Drug Administration (FDA) at University Hospitals. However, FDA approval has been obtained for this study protocol by an Investigational New Drug (IND) application.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients must have a history of prostate cancer
- •Patients have known or highly suspected osseous metastatic involvement defined by the referring physician based on clinical history and/or findings from standard of care imaging.
- •Patients ≥ 18 years old
- •Patients able to tolerate PET/CT scans
- •Informed written consent must be given and signed
排除标准
- •Subjects who do not meet the noted inclusion criteria
- •Patients < 18 years old
- •Subjects who refuse to give or are unable to sign the informed consent
- •Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
- •Patients with a known allergy against Ga-68 PSMA or F-18 NaF
研究组 & 干预措施
[F-18]NaF
Patients will receive 8-12 mCi of [F-18]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging.
干预措施: [68Ga]PSMA (Drug)
[F-18]NaF
Patients will receive 8-12 mCi of [F-18]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging.
干预措施: Flourine-18 [F-18] Sodium Fluoride (NaF) (Drug)
[F-18]NaF
Patients will receive 8-12 mCi of [F-18]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging.
干预措施: PET/CT (Diagnostic Test)
[Ga-68]PSMA
Patients will receive up to 6 mCi of [Ga-68]PSMA delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging
干预措施: [68Ga]PSMA (Drug)
[Ga-68]PSMA
Patients will receive up to 6 mCi of [Ga-68]PSMA delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging
干预措施: Flourine-18 [F-18] Sodium Fluoride (NaF) (Drug)
[Ga-68]PSMA
Patients will receive up to 6 mCi of [Ga-68]PSMA delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging
干预措施: PET/CT (Diagnostic Test)
结局指标
主要结局
Uptake of [Ga-68]PSMA as measured by lesion by lesion analysis
时间窗: Up to 90 minutes
Classified using a 5-point score with one being definitely metastatic and five being definitely benign
次要结局
- Focally increased [Ga-68]PSMA uptake as measured by PET/CT(Up to 90 minutes)
研究者
Norbert Avril
Division Chief, Nuclear Medicine
University Hospitals Cleveland Medical Center