NCT02462200终止2 期
Shave Margins in Breast Conservation Therapy (SMART): A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Compare intraoperative NIR fluorescence from goggle system with pathologic tissue exam results
研究概览
简要总结
The investigators propose a randomized controlled superiority trial of standard breast-conserving surgery (BCS) versus BCS with cavity shave margins (CSM). The main objectives of this trial will be to evaluate prospectively the impact of routine standardized CSM on margin status following primary surgery for early stage breast cancer (Stage 0 - II), on post-operative patient satisfaction and cosmetic outcomes, and on general intraoperative time and operative costs. A parallel group format will be implemented to compare this modified surgical therapy - BCS with CSM - with BCS alone, which is the current standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed, biopsy-proven stage 0-II breast cancer.
- •Planning to undergo breast-conserving surgery.
- •At least 18 years of age and no more than 85 years of age.
- •Able to understand and willing to sign an IRB-approved written informed consent document.
排除标准
- •Prior surgical treatment for this diagnosis.
- •Undergone neoadjuvant chemotherapy.
- •History of prior chest radiation therapy.
- •Known metastatic disease.
- •Pregnant.
- •Preference for mastectomy instead of breast-conserving surgery.
- •History of ipsilateral breast cancer.
- •Goggle assessment substudy: Iodine or seafood allergies.
研究组 & 干预措施
BCS Arm (breast-conserving surgery - standard of care)
Active Comparator
- Defined as partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization
- The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (except for those patients with iodine or seafood allergies or in cases where the goggles are unavailable for use).
- Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of and CSM that are taken.
干预措施: BREAST-Q Questionnaire (Behavioral)
BCS Arm (breast-conserving surgery - standard of care)
Active Comparator
- Defined as partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization
- The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (except for those patients with iodine or seafood allergies or in cases where the goggles are unavailable for use).
- Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of and CSM that are taken.
干预措施: Breast-conserving surgery (BCS) (Procedure)
BCS Arm (breast-conserving surgery - standard of care)
Active Comparator
- Defined as partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization
- The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (except for those patients with iodine or seafood allergies or in cases where the goggles are unavailable for use).
- Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of and CSM that are taken.
干预措施: 3-D breast imaging (Device)
BCS Arm (breast-conserving surgery - standard of care)
Active Comparator
- Defined as partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization
- The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (except for those patients with iodine or seafood allergies or in cases where the goggles are unavailable for use).
- Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of and CSM that are taken.
干预措施: Intraoperative imaging device (Device)
BCS Arm (breast-conserving surgery - standard of care)
Active Comparator
- Defined as partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization
- The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (except for those patients with iodine or seafood allergies or in cases where the goggles are unavailable for use).
- Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of and CSM that are taken.
干预措施: Peripheral blood draw (Procedure)
CSM Arm (breast-conserving surgery with cavity shave margins)
Experimental
- Partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization with the addition of additional tissue specimens from all 6 margins (anterior, posterior, superior, inferior, medial, lateral) of the wound cavity if possible. In cases where an additional margin would involve the skin at the anterior margin and/or the pectoral muscle at the posterior margin, only the 4 (or 5) remaining margins should be obtained
- A margin thickness of 1 cm will be the defined goal to establish uniformity among different surgeons and allow for appropriate pathological evaluation
- The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (no iodine or seafood allergies).
- Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of any CSM that are taken.
干预措施: Cavity shave margins (CSM) (Procedure)
CSM Arm (breast-conserving surgery with cavity shave margins)
Experimental
- Partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization with the addition of additional tissue specimens from all 6 margins (anterior, posterior, superior, inferior, medial, lateral) of the wound cavity if possible. In cases where an additional margin would involve the skin at the anterior margin and/or the pectoral muscle at the posterior margin, only the 4 (or 5) remaining margins should be obtained
- A margin thickness of 1 cm will be the defined goal to establish uniformity among different surgeons and allow for appropriate pathological evaluation
- The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (no iodine or seafood allergies).
- Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of any CSM that are taken.
干预措施: BREAST-Q Questionnaire (Behavioral)
CSM Arm (breast-conserving surgery with cavity shave margins)
Experimental
- Partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization with the addition of additional tissue specimens from all 6 margins (anterior, posterior, superior, inferior, medial, lateral) of the wound cavity if possible. In cases where an additional margin would involve the skin at the anterior margin and/or the pectoral muscle at the posterior margin, only the 4 (or 5) remaining margins should be obtained
- A margin thickness of 1 cm will be the defined goal to establish uniformity among different surgeons and allow for appropriate pathological evaluation
- The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (no iodine or seafood allergies).
- Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of any CSM that are taken.
干预措施: Breast-conserving surgery (BCS) (Procedure)
CSM Arm (breast-conserving surgery with cavity shave margins)
Experimental
- Partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization with the addition of additional tissue specimens from all 6 margins (anterior, posterior, superior, inferior, medial, lateral) of the wound cavity if possible. In cases where an additional margin would involve the skin at the anterior margin and/or the pectoral muscle at the posterior margin, only the 4 (or 5) remaining margins should be obtained
- A margin thickness of 1 cm will be the defined goal to establish uniformity among different surgeons and allow for appropriate pathological evaluation
- The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (no iodine or seafood allergies).
- Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of any CSM that are taken.
干预措施: 3-D breast imaging (Device)
CSM Arm (breast-conserving surgery with cavity shave margins)
Experimental
- Partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization with the addition of additional tissue specimens from all 6 margins (anterior, posterior, superior, inferior, medial, lateral) of the wound cavity if possible. In cases where an additional margin would involve the skin at the anterior margin and/or the pectoral muscle at the posterior margin, only the 4 (or 5) remaining margins should be obtained
- A margin thickness of 1 cm will be the defined goal to establish uniformity among different surgeons and allow for appropriate pathological evaluation
- The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (no iodine or seafood allergies).
- Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of any CSM that are taken.
干预措施: Intraoperative imaging device (Device)
CSM Arm (breast-conserving surgery with cavity shave margins)
Experimental
- Partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization with the addition of additional tissue specimens from all 6 margins (anterior, posterior, superior, inferior, medial, lateral) of the wound cavity if possible. In cases where an additional margin would involve the skin at the anterior margin and/or the pectoral muscle at the posterior margin, only the 4 (or 5) remaining margins should be obtained
- A margin thickness of 1 cm will be the defined goal to establish uniformity among different surgeons and allow for appropriate pathological evaluation
- The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (no iodine or seafood allergies).
- Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of any CSM that are taken.
干预措施: Peripheral blood draw (Procedure)
CSM Arm (breast-conserving surgery with cavity shave margins)
Experimental
- Partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization with the addition of additional tissue specimens from all 6 margins (anterior, posterior, superior, inferior, medial, lateral) of the wound cavity if possible. In cases where an additional margin would involve the skin at the anterior margin and/or the pectoral muscle at the posterior margin, only the 4 (or 5) remaining margins should be obtained
- A margin thickness of 1 cm will be the defined goal to establish uniformity among different surgeons and allow for appropriate pathological evaluation
- The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (no iodine or seafood allergies).
- Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of any CSM that are taken.
干预措施: Indocyanine green (Other)
BCS Arm (breast-conserving surgery - standard of care)
Active Comparator
- Defined as partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization
- The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (except for those patients with iodine or seafood allergies or in cases where the goggles are unavailable for use).
- Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of and CSM that are taken.
干预措施: Indocyanine green (Other)
结局指标
主要结局
Compare intraoperative NIR fluorescence from goggle system with pathologic tissue exam results
时间窗: Completion of surgery for all enrolled patients (approximately 60 months)
Patient perceptions of the surgery as measured by BREAST-Q questionnaire and novel 3-dimensional breast imaging
时间窗: 6-12 months post-surgery or post-radiation therapy, whichever is later)
* The BREAST-Q questionnaire consists of 13 sections. * The sections ask the patient questions about how they feel about how their breast area looks, how they feel emotionally, any physical side effects, and sexual side effects. * Some of the sections ask the patients to answer a question on a scale of None of the Time (equals=1) to All of the Time (equals=5) * Some of the sections ask the patients to answer a question on a scale of Very Dissatisfied (equals=1) to Very Satisfied (equals=4)
Proportion of patients with positive margins on pathological specimen analysis
时间窗: Completion of surgery for all enrolled patients (approximately 60 months)
次要结局
- Tumor characteristics associated with cancer biomarkers(Completion of surgery for all enrolled patients (approximately 60 months))
- Relationship between CSM and volume of tissue excised in association iwth post-operative aesthetic outcomes(6-12 months post-surgery or post-radiation therapy, whichever is later))
- Cost-effectiveness of routine CSM in BCS as measured by operative time, specimen processing, and resource usage(Completion of surgery for all enrolled patients (approximately 60 months))
- Disease status associated with cancer biomarkers(Completion of surgery for all enrolled patients (approximately 60 months))
研究者
研究点 (1)
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