Use of SPECT-CT for Comparison of Dosimetry Methods in PSMA-targeted Radioligand Therapy (SPECTacular Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- BAMF Health
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Dosimetry Method
研究概览
简要总结
The SPECTacular study will enroll patients who are already undergoing a FDA approved PSMA-targeted Radioligand treatment cycle. During each treatment cycle, patients will receive 5 additional SPECT/CT scans to investigate the limits of agreement between dosimetry (absorbed radiation dose) approximation methods and dosimetry using the triexponential fitting method.
详细描述
All patients with PSMA-positive tumor and/or Metastases of Prostate Cancer (PSMA-TMPC) who would be undergoing a PSMA-targeted Radioligand Therapy (PRLT) based on independent eligibility criteria for the same, will receive 6 serial SPECT-CT scans for every treatment cycle as a part of our study. The purpose of this investigation is to assess the limits of agreement of commonly employed dosimetry methods used to determine or approximate absorbed doses for organs and tumors compared to a dosimetry method using a triexponential fit requiring 6 post-injection SPECT-CT scans for all treatment cycles.
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male, 18 years old or older
- •Histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component.
- •Patient is receiving PSMA-targeted Radioligand Therapy (PRLT) for treatment of PSMA-positive tumor and/or metastases of prostate cancer. Therapy may be FDA approved or investigational in nature under an approved clinical trial.
- •Ability to lay flat on scanner for duration of SPECT-CT imaging studies (1-2 hours)
排除标准
- •Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 2
- •All criteria which may preclude a PSMA-radioligand therapy using Lu-177 PSMA-617 or Lu-177 PSMA I&T to be performed as per standardized guidelines and protocols laid down for these treatments and per decision by the treating physician.
结局指标
主要结局
Dosimetry Method
时间窗: Immediately after the completion of SPECT/CT scanning.
To determine the limits of agreements between dosimetry approximation methods and dosimetry using the triexponential fitting method.
次要结局
未报告次要终点