99mTc-PSMA-I&Amp;S in Patients With Prostate Cancer: An Exploratory Biodistribution Study With Histopathology Validation
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The biodistribution of 99mTc-PSMA-I&S in normal and malignant tissues of patients with prostate cancer will be measured by average and maximum standardized uptake value (SUVmean and SUVmax)
研究概览
简要总结
This exploratory study conducted under the RDRC program studies the biodistribution of 99mTc-PSMA-I&S in patients with prostate cancer who undergo pelvic lymph node dissection. Prostate specific membrane antigen (PSMA)-targeted radio-guided surgery uses the preoperative intravenous administration of a PSMA-ligand called PSMA-imaging and surgery (I&S) labeled with the gamma-emitter radioisotope Technetium-99m (99mTc). Giving 99mTc-PSMA-I&S may detect PSMA-expressing lymph nodes during surgery using a gamma probe and may help guide doctors to detect prostate cancer that has spread to the lymph nodes.
详细描述
PRIMARY OBJECTIVE:
I. To define the biodistribution of 99mTc-based PSMA imaging and surgery agent (99mTc-PSMA-I&S) in normal and malignant tissues of patients with prostate cancer (PCa) with histopathology validation, when available.
SECONDARY OBJECTIVES:
I. To correlate the 99mTc-PSMA-I&S accumulation within tumor lesions observed by in-vivo single-photon emission computed tomography (SPECT), ex-vivo gamma measurements and level of prostate-specific membrane antigen (PSMA) expression quantified by histopathology, when available.
II. To define the best time-point for radio-guided surgery (RGS) with the highest tumor-to-background ratio following 99mTc-PSMA-I&S administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with PCa (primary or recurrent disease)
- •Men who received a 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) for staging or restaging
- •Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET/CT
- •Men who are scheduled for pelvic LN dissection (PLND)
- •Men who can provide oral and written informed consent
- •Men who can comply with study procedures
排除标准
- •Patients who started any PCa treatment between study enrollment and surgery
- •Technically inaccessible nodal location
研究组 & 干预措施
Diagnostic (99mTc-PSMA-I&S, SPECT/CT)
The first 5 patients receive an initial dose of undergo 99mTc-PSMA-I&S IV followed by 5 SPECT/CT scans at 3-5, 5-20, 17-21, 25-29, and 40-46 hours later. These 5 patients then receive a second dose of 99mTc-PSMA-I&S IV and then undergo standard of care surgery. All subsequent patients receive one dose of 99mTc-PSMA-I&S IV before standard of care surgery.
干预措施: Single Photon Emission Computed Tomography (Procedure)
Diagnostic (99mTc-PSMA-I&S, SPECT/CT)
The first 5 patients receive an initial dose of undergo 99mTc-PSMA-I&S IV followed by 5 SPECT/CT scans at 3-5, 5-20, 17-21, 25-29, and 40-46 hours later. These 5 patients then receive a second dose of 99mTc-PSMA-I&S IV and then undergo standard of care surgery. All subsequent patients receive one dose of 99mTc-PSMA-I&S IV before standard of care surgery.
干预措施: 99mTc-based PSMA Imaging and Surgery Agent (Drug)
Diagnostic (99mTc-PSMA-I&S, SPECT/CT)
The first 5 patients receive an initial dose of undergo 99mTc-PSMA-I&S IV followed by 5 SPECT/CT scans at 3-5, 5-20, 17-21, 25-29, and 40-46 hours later. These 5 patients then receive a second dose of 99mTc-PSMA-I&S IV and then undergo standard of care surgery. All subsequent patients receive one dose of 99mTc-PSMA-I&S IV before standard of care surgery.
干预措施: Computed Tomography (Procedure)
结局指标
主要结局
The biodistribution of 99mTc-PSMA-I&S in normal and malignant tissues of patients with prostate cancer will be measured by average and maximum standardized uptake value (SUVmean and SUVmax)
时间窗: time from injection to imaging (range: 1-46 hours)
次要结局
- The best time-point for 99mTc-PSMA-I&S radioguided surgery will be determined by the tumor-to-background uptake ratio (TBR) using the time-activity curve function(time from injection to imaging (range: 1-46 hours))
- 99mTc-PSMA-I&S accumulation within tumor lesions observed by in-vivo SPECT (SUVmean and SUVmax) will be correlated with ex-vivo gamma measurements (counts/minute) and level of PSMA expression quantified by histopathology (IHC score)(time from injection to imaging (range: 1-46 hours))