跳至主要内容
临床试验/NCT02225925
NCT02225925已完成不适用

Phase II Study of Dynamic Intraoperative Dosimetry for Prostate Brachytherapy Using Registered Fluoroscopy and Ultrasound

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2014年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Procedure Time

研究概览

简要总结

The purpose of this study is to assess the performance of a system of intraoperative dynamic dosimetry during prostate seed implantation (brachytherapy) including its new elements, to evaluate and refine technical methods of using the system, as well as confirm its performance and accuracy.

详细描述

The use of brachytherapy or implantation of radioactive sources into the prostate for adenocarcinoma has advantages over external beam radiation in that a very high dose can be delivered to the tumor while limiting the doses to the surrounding normal tissue (i.e., bowel and bladder). It is established that outcomes after treatment with brachytherapy are related to the technical quality of source placement within the gland. Accurate placement of the radioactive sources with achievement of optimum dose distributions within the prostate is key to the success of brachytherapy with regard to both killing tumor as well as minimizing toxicity.

Due to factors such as deformations of the prostate during needle insertion, needle deviation from intended path during insertion, prostatic edema from needle trauma, and relaxation of tissues as well as source migration after needle removal, the actual source positions upon completion of the procedure may fail to accurately match their intended placement, resulting in variations from the idealized dosimetric plan.

One way to overcome this complex problem is to have the capability of visualizing the sources once they are in the prostate and then continuously updating the dosimetric plan in real time. To this end, we have developed a mechanism whereby ultrasound and fluoroscopy are quantitatively integrated to allow for real-time visualization of source positions intraoperatively. A prior Phase I study performed by this group evaluated a prototype version of this mechanism, resulting in the successful treatment of 6 patients with true intraoperative dynamic dosimetry. Dosimetric outcomes within this cohort of patients was excellent, and the intraoperative doses predicted by the system more accurate than that predicted by the current standard method (ultrasound-based dosimetry).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • •Histologically confirmed, localized adenocarcinoma of the prostate
  • •Clinical stages T1b - T3a
  • •The patient has decided to undergo brachytherapy (or brachytherapy plus external beam radiation) as a treatment modality for his prostate cancer
  • •Karnofsky Performance Status > 60
  • •Prostate volume by transrectal ultrasound (TRUS) < 55 cc
  • •International Prostate symptom score (IPSS) 20 or less
  • •Ability to have Magnetic resonance imaging as part of post-implant assessment
  • •Signed study-specific consent form prior to registration

排除标准

  • •Stage T3b or greater disease.
  • •Prior history of pelvic radiation therapy
  • •Significant obstructive symptoms (IPSS greater than 20)
  • •Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.
  • •Implanted device or apparatus which obstruct visibility of the implanted sources on fluoroscopy
  • •Metallic implants, claustrophobia not amenable to medication, or known contraindications to undergoing MR scanning

研究组 & 干预措施

Dynamic dosimetry brachytherapy

Experimental

Cohort treated with dynamic dosimetry brachytherapy

干预措施: Brachytherapy (Radiation)

结局指标

主要结局

Procedure Time

时间窗: at time of implantation procedure

Additional procedure time with the registered ultrasound and fluoroscopy system (RUF) in the intra-operative setting for implantation procedure

次要结局

  • Seed Reconstruction From Intra-operative Fluoroscopy(up to 30 days post-treatment)
  • Impact of RUF System on Dosimetric Outcomes of Seed Placement as Assessed by Number of Patients With Prostate V100 of 95% or Greater(30 days post-treatment)
  • Prostate Specific Antigen (PSA) Outcomes(up to 5 years)
  • Number of Participants With Seed Reconstruction Utilizing RUF Versus CT / Magnetic Resonance Imaging (MRI) Reconstruction(30 days post-treatment)
  • Mean Difference in D90 Between Intra-operative RUF and Standard CT/MRI Based Dosimetry(Treatment - 30 days)
  • Dosimetric Accuracy Comparison Between Pre and Post Ultrasound (US) Implantation Prostate Edema(Treatment - 30 days)
  • Quality of Life (QoL) Assessments(baseline, 30 days post-implant, semiannually post treatment until year 2 and then annually until year 5)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验