A Registry Study of Permanent Breast Seed Implant
2021年10月22日 更新者：Dr. Eric Leung、Sunnybrook Health Sciences Centre
A Multicentre Registry Study of Permanent Breast Seed Implant (PBSI) for Early Stage Breast Cancers.
Women found to have early stage breast cancer will have their cancer surgically removed followed by radiation treatment to the entire breast, five times per week for several weeks. The radiation treatment prevents the cancer from growing back but creates skin burns. Several studies have showed that it is nor necessary treating the whole breast.
The investigators team has pioneered a new therapy realizing the permanent implantation of tiny radioactive seeds into the surgical cavity in a single one hour procedure under light anesthesia. Patients live a normal life while receiving the radiation treatment. The results of a first clinical trial on 67 patients shows that the treatment is well tolerate and efficient. The purpose of the study is to offer the treatment in several places and to increase the cohort of patient to 420 to capture rare complications if any.
研究概览
详细说明
For early stage breast cancer, accelerated partial breast irradiation is an alternative treatment option to whole breast irradiation after breast conserving surgery. Our group has previously reported results of a Phase I/II study of permanent breast seed implant (PBSI) using palladium-103 seeds as an alternative to whole breast radiotherapy for well selected breast cancer patients. The procedure is realised in a single session under light sedation and local freezing. After a median FU of 54 months no patients has recurred on a cohort of 67 patients, and acute of delayed side effect compared favourably to external beam radiotherapy.
Yet this study was a single centre study and the sample size did not allow evaluating appropriately the risk of serious adverse events (SAE). The current study propose evaluating SAE on a multicentre and larger cohort of 420 patients.
研究类型
介入性
注册 (实际的)
420
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ontario
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Toronto、Ontario、加拿大、M4N3M5
- Sunnybrook Odette Cancer Centre
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- A confirmed histological diagnosis of invasive breast carcinoma
- Treated by breast conserving surgery with axillary node dissection (with a minimum of 6 nodes sampled) or sentinel lymph node biopsy
- Surgical margins clear over or equal to 2 mm
- A maximum tumor size of 3 cm
- Age >= 50 years old
- ECOG performance status of 0 or 1
- Informed consent signed
Exclusion Criteria:
- Previous history of cancer other than curable skin SCC or Tis or T1 cervix
- Patient receiving anti-coagulant that cannot be stopped two weeks prior PBSI
- Autoimmune disorder
- Diabetes insulin-dependant
- Pregnancy
- Breast implants
- Psychiatric or addictive disorder that would preclude attending follow-up
- Post-operative breast infection
- Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)
- Lobular features on histology (pure or mixed) or sarcoma histology
- Node positive on axillary dissection or in the sentinel lymph node biopsy
- Extensive in situ carcinoma
- Multicentric disease (in more than one quadrant or separated by 2 cm or more)
- Paget's disease of the nipple
- Metastases
- Patients presenting a post-surgical fluid cavity ≥ 2.5 cm in diameter in any dimension as determined on the planning US
- Clear delineation of the target volume on CT is not possible
- Having a volume to be implanted over 120cc
- Having a target volume too close to skin such that the 85% isodose overlaps the skin surface)
- Having a target volume too close to the chest wall, such that there is a risk of perforating the chest wall
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：PBSI
PBSI is a form of accelerated partial breast irradiation involving the insertion of 103-palladium stranded seeds under ultra-sound guidance and light sedation after CT planning in lieu of whole breast adjuvant radiotherapy.
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Patients are pre-planned using CT simulation.
Implant is realised under light sedation and local freezing.
Stranded seeds are inserted using a brachytherapy template that is immobilised to the planned target volume using a 'localization' needle.
Patients is released the same day and Quality Assurance involves a 2 months post-implant CT
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Serious Adverse Events
大体时间：Initial and then yearly up to 5 years
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Serious Adverse Events (SAE) is an unintended sign, symptom, or syndrome illness that occurs during the period of observation in the clinical study and that is life threatening or result in death.
SAE will be coded using the NCI CTC V3.0 scale and corresponds to grade 4 or 5 signs or symptoms.
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Initial and then yearly up to 5 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Breast cancer local recurrence
大体时间：Yearly up to 10 years
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Ipsilateral in-breast or chest wall recurrence is defined as evidence of invasive or in situ breast cancer (except LCIS) in the ipsilateral breast.
Patients will have a biopsy of the suspicious lesion to confirm the diagnosis with documentation of the location.
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Yearly up to 10 years
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Regional recurrence
大体时间：Yearly up to 10 years
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Regional recurrence is defined as the development of tumor in regional nodes as well as the soft tissue of the ipsilateral axilla after axillary dissection.
The regional recurrence is suspected on imaging and/or clinical symptoms and must be documented with fine needle aspiration.
Also the localisation of the nodal recurrence must be reported (internal mammary chain, supra-clavicular area or axilla).
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Yearly up to 10 years
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Metastases
大体时间：Yearly up to 10 years
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Distant recurrence is defined as evidence of tumor in any area of the body.
The metastasis recurrence should be proved by appropriate imaging, biopsy or fine needle aspiration
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Yearly up to 10 years
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PBSI side effects
大体时间：After procedure
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Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
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After procedure
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PBSI side effects
大体时间：At 2 months
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Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
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At 2 months
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PBSI side effect
大体时间：At 6 months
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Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
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At 6 months
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PBSI side effect
大体时间：Yearly up to 10 years
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Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
Fat necrosis will be diagnosed either by mammography or clinically (prolonged indurations and pain in the area of seeds implantation without evidence of infection).
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Yearly up to 10 years
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Cosmetic outcome
大体时间：Yearly up to 10 years
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Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist.
An excellent cosmetic result score is assigned when the treated breast looked essentially the same as the contralateral breast (as it relates to radiation effects).
A good cosmetic score is assigned for minimal but identifiable radiation effects of the treated breast.
A fair score means significant radiation effects were readily observable.
A poor score is used for severe sequelae of breast tissue secondary to radiation effects.
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Yearly up to 10 years
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Survival
大体时间：Yearly up to 10 years
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Patient survival, either free of cancer or with disease present will be recorded at follow-up appointments.
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Yearly up to 10 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Eric Leung, MD、Sunnybrook Health Sciences Centre
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Pignol JP, Keller B, Rakovitch E, Sankreacha R, Easton H, Que W. First report of a permanent breast 103Pd seed implant as adjuvant radiation treatment for early-stage breast cancer. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):176-81. doi: 10.1016/j.ijrobp.2005.06.031. Epub 2005 Sep 22.
- Keller BM, Pignol JP, Rakovitch E, Sankreacha R, O'Brien P. A radiation badge survey for family members living with patients treated with a (103)Pd permanent breast seed implant. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):267-71. doi: 10.1016/j.ijrobp.2007.08.006. Epub 2007 Oct 29.
- Keller B, Sankreacha R, Rakovitch E, O'brien P, Pignol JP. A permanent breast seed implant as partial breast radiation therapy for early-stage patients: a comparison of palladium-103 and iodine-125 isotopes based on radiation safety considerations. Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):358-65. doi: 10.1016/j.ijrobp.2004.10.014.
- Pignol JP, Rakovitch E, Keller BM, Sankreacha R, Chartier C. Tolerance and acceptance results of a palladium-103 permanent breast seed implant Phase I/II study. Int J Radiat Oncol Biol Phys. 2009 Apr 1;73(5):1482-8. doi: 10.1016/j.ijrobp.2008.06.1945. Epub 2008 Oct 18.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年3月1日
初级完成 (实际的)
2018年1月19日
研究完成 (实际的)
2018年1月19日
研究注册日期
首次提交
2010年4月9日
首先提交符合 QC 标准的
2010年4月19日
首次发布 (估计)
2010年4月20日
研究记录更新
最后更新发布 (实际的)
2021年10月29日
上次提交的符合 QC 标准的更新
2021年10月22日
最后验证
2021年10月1日
更多信息
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