99mTechnetium Based PSMA-Radioguided Assisted Surgery for Prostate Cancer (TRACE) Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- sensibility of 99mTc-PSMA Radioguided surgery in lymph node dissection
研究概览
简要总结
PSMA-radioguided surgery
详细描述
Given the difficulty visualizing lymph node involvement with pre-operative imaging alone, and the potential to miss metastatic nodal involvement on template PLND, radioguided surgery has been proposed as a technique to improve intra-operative detection and clearance. 99mTechnetium (99mTc) is a frequently used radioisotope in nuclear medicine, with favourable radiation properties and commercial availability[11]. It has a 6-hour half-life, and is suited to allow target tissue accumulation, while minimizing patients and investigator radiation exposure. Novel molecule-targeted radiopharmaceuticals using 99mTC and other radioisotopes in the setting of PC have increasing potential for diagnostic imaging, monitoring of therapeutic interventions and directed surgery[11, 12]. In relation to radioguided surgery, 99mTC -based PSMA-radioguided surgery (99mTc-PSMA-RGS) was deployed in a feasibility study. Using a specifically designed 99mTc based tracer, 99mTc-mas3-y-nal-k(Sub-KuE), or in short Tc-99m-PSMA I&S, combined with a gamma probe, guidance of the surgical resection of recurrent PC lymph node metastases was undertaken in 132 patients, yielding a sensitivity of 84% and specificity of 100% and detecting metastases as small as 3mm[15, 16]. This raises the question as to whether a combination of PSMA PET/CT imaging and PSMA-radioguided surgery may increase the cure rate in patients undergoing operative management of PC, by increasing detection sensitivity and specificity of nodal metastases.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Male, aged ≥ 18 years.
- •Hormone-sensitive recurrent prostate cancer after radical prostatectomy
- •<3 soft tissue lesions (lymph node; connective tissue) within the pelvis or retroperitoneum with sufficient PSMA expression (≥3 times regional vascular activity level) as determined by PSMA-based PET
- •PSA-value <4ng/mL
- •Had a PSMA PET/CT within 60 days before surgery
- •Suitable for salvage lymph node dissection, as per institutional guidelines.
- •WHO performance status 0,1, or
- •Written informed consent.
排除标准
- •Suspicion of local recurrent prostate cancer within the prostatic fossa not treatable by surgery
- •Nonregional lymphadenopathy (cM1a) or distant metastases (cM1b/c) as assessed by preoperative PSMA PET/CT.
- •Ongoing androgen deprivation therapy (ADT) or within 6 months prior to surgery.
- •Severe claustrophobia interfering with PET/CT or SPECT/CT scanning.
结局指标
主要结局
sensibility of 99mTc-PSMA Radioguided surgery in lymph node dissection
时间窗: through study completion, an average of two days
sensibility of 99mTc-PSMA-I\&S by calculating the percentage of PSMA avid lymph nodes
次要结局
未报告次要终点
