跳至主要内容
临床试验/NCT05816837
NCT05816837招募中不适用

Displacement Distance and Stabilization Time for Liver Fiducial Marker

Peking University Third Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Displacement distance

研究概览

简要总结

Liver malignant tumor, including liver cancer and liver metastasis, is common in China [1]. Previous studies have shown that cyber-knife stereotactic radiotherapy is effective and safe for locally advanced liver malignancies with improved local tumor control [2]. Real-time tumor tracking in cyber-knife stereotactic radiotherapy is currently used as tumors have respiratory movements [3]. At present, fiducial marker is used to realize the real-time track of tumor [4, 5]. However, the fiducial marker are likely to displacement usually within 7 days after implantation [4, 6, 7]. Therefore, simulated CT are delayed 7 days before the fiducial marker stabilization and significantly extend the radiotherapy planning process, increase the risk of tumor progression. As far as we know, there is no prospective study on the specific displacement distance and duration before the fiducial marker stabilization after implantation. Therefore, the purpose of this study was to study the displacement distance and stabilization time before stereotactic radiotherapy for liver malignant tumors guided by 3D printing template-assisted CT.

  1. B.K. Chang, R.D. Timmerman, Stereotactic body radiation therapy: a comprehensive review, Am J Clin Oncol 30 (6) (2007) 637-644.
  2. Kato Y, Kamomae T, Kumagai M, Oie Y, Noguchi Y, Okudaira K, et al. Hybrid 3D T1-weighted gradient-echo sequence for fiducial marker detection and tumor delineation via magnetic resonance imaging in liver stereotactic body radiation therapy. 2022;95:9-15.
  3. D.K. Bhasin, S.S. Rana, S. Jahagirdar, B. Nagi, Does the pancreas move with respiration? J Gastroenterol Hepatol 21 (9) (2006) 1424-1427.
  4. N. Kothary, J.J. Heit, J.D. Louie, W.T. Kuo, B.J. Loo, A. Koong, D.T. Chang, D. Hovsepian, D.Y. Sze, L.V. Hofmann, Safety and efficacy of percutaneous fiducial marker implantation for image-guided radiation therapy, J. Vasc. Interv. Radiol. 20 (2) (2009) 235-239.
  5. C.G. Trumm, S.M. Häussler, A. Muacevic, R. Stahl, S. Stintzing, P.M. Paprottka, F. Strobl, T.F. Jakobs, M.F. Reiser, R.T. Hoffmann, CT fluoroscopy-guided percutaneous fiducial marker placement for CyberKnife stereotactic radiosurgery: technical results and complications in 222 consecutive procedures, J. Vasc. Interv. Radiol. 25 (5) (2014) 760-768.
  6. Y. Seppenwoolde, W. Wunderink, V.S. Wunderink-van, P. Storchi, R.A. Méndez, B.J. Heijmen, Treatment precision of image-guided liver SBRT using implanted fiducial markers depends on marker-tumour distance, Phys. Med. Biol. 56 (17) (2011) 5445-5468.
  7. K. Valentine, T. Cabrera, D. Roberge, Implanting metal fiducials to guide stereotactic liver radiation: McGill experience and review of current devices, techniques and complications, Technol Cancer Res Treat 13 (3) (2014) 253-258.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18 to 85
  • Single or multiple liver tumors or mass (solid, partially solid)
  • Without taking drugs affecting coagulation and/or platelet aggregation are used; If used, the drug has been discontinued for a sufficient period of time (e.g. 1 week)
  • KPS>60 points, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
  • Planned fiducial marker implantation with applicable puncture path
  • With informed consent.

排除标准

  • Poor organ function
  • The lesion close to blood vessels and intestine, or there is portal vein hypertension and superior vena cava compression, etc., which are expected to have high risks of puncture bleeding and intestinal injury
  • Poor compliance, unable to complete coordination
  • Paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.

结局指标

主要结局

Displacement distance

时间窗: Within 1 weeks

Fiducial marker displacement distance (millimeter) in the liver after implantation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Qiu Bin

Principal Investigator

Peking University Third Hospital

研究点 (2)

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