Shave Margins in Breast Conservation Therapy | NCT02462200

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Procedure: Breast-conserving surgery (BCS) Behavioral: BREAST-Q Questionnaire Device: 3-D breast imaging Other: Indocyanine green Device: Intraoperative imaging device Procedure: Peripheral blood draw
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.	Procedure: Breast-conserving surgery (BCS) Procedure: Cavity shave margins (CSM) Behavioral: BREAST-Q Questionnaire Device: 3-D breast imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breast-conserving surgery (BCS)	Procedure		BCS Arm (breast-conserving surgery - standard of care) CSM Arm (breast-conserving surgery with cavity shave margins)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients with positive margins on pathological specimen analysis		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	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)	6-12 months post-surgery or post-radiation therapy, whichever is later)
Compare intraoperative NIR fluorescence from goggle system with pathologic tissue exam results		Completion of surgery for all enrolled patients (approximately 60 months)

Secondary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D015412	Mastectomy, Segmental
D007208	Indocyanine Green

ID	Term
D008408	Mastectomy
D013514	Surgical Procedures, Operative
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds