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临床试验/NCT03857113
NCT03857113Unknown不适用

99mTechnetium Based PSMA-Radioguided Assisted Surgery for Prostate Cancer (TRACE) Feasibility Study

The Netherlands Cancer Institute1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年3月11日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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