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临床试验/NCT04929197
NCT04929197Enrolling By Invitation不适用

Evaluation of the Feasibility of Developing Personalized Breast Cancer Radiotherapy Assistive Device With Three-dimensional Printing Secondary IDs:

Taipei Medical University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年4月21日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
50
试验地点
1
主要终点
Irradiated cardiac dose

研究概览

简要总结

Breast cancer is the most common malignancy among women worldwide. For early stage breast cancer, adjuvant radiotherapy is essential to minimize loco-regional disease recurrence. However, significant portions of the heart and the lungs are exposed to low dose radiation during radiotherapy, which result in stochastic side effects among breast cancer survivors. Inspired by 3D printing technology, we approached this issue with an in-house made PERSonalized BReAst holder system (PERSBRA). PERSBRA is composed of a 3D-printed plastic holder covering the whole breast and an air-filled interface. Its main function is to reproducibly adjust the breast position to decrease heart and lung radiation exposure in tangential fields. Here we propose to measure the performance of PERSBR in terms of radiation dosimetry in 50 patients receiving scheduled whole breast irradiation. For customized PERSBRA, body shape of the patient with or without a bustier corset will be captured with a handheld 3D scanner and input into a 3D printer for PERSBRA design and manufacturing. A participant will receive two more CT scans in addition to the simulation scan with PERSBRA in place before the first and the sixth fractions of irradiation. These images will be analyzed for dosimetric parameters in the presence/absence of PERSBRA as well as position reproducibility. The data will provide proof-of-principle evidence for the clinical utility of PERSBRA and will facilitate its further refinement.

详细描述

  1. Patients with early breast cancer or ductal carcinoma in situ treated with breast conservation surgery.
  2. Adjuvant radiotherapy to the breast is part of the patient's initial treatment plan.
  3. Non-contrast CT scan is a routine procedure for the patient's radiotherapy treatment planning.

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

性别
Female
接受健康志愿者

入选标准

  • Patients with early breast cancer or carcinoma in situ after partial mastectomy have decided to receive adjuvant radiation therapy for the breast on the affected side, and use non-contrast computed tomography to obtain localized images is part of the original treatment plan.

排除标准

  • Clinical diagnosis or pathological diagnosis has lymph node metastasis, lymph node micrometastasis, or lymph node tumor cells.
  • The clinical diagnosis is likely to have metastatic cancer.
  • Pregnant women.
  • Be younger than 20 years old.
  • The subject was unable to read and understand the subject consent form written in Chinese and complete the informed consent procedure.

结局指标

主要结局

Irradiated cardiac dose

时间窗: Time Frame: At simulation, expected average of 1 week

Radiation dose distribution of the cardiopulmonary on the affected side.

次要结局

  • Irradiated dose of left anterior descending artery(Time Frame: At simulation, expected average of 1 week)
  • Clinical target volume(At simulation, expected average of 1 week)
  • Irradiated dose of axillary lymphatic area(At simulation, expected average of 1 week)
  • Irradiated lung dose(At simulation, expected average of 1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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