Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction

Not Applicable

Completed

Conditions: Ductal Carcinoma in Situ - Category
Breast Cancer
Prophylactic Mastectomy

Interventions: Procedure: Inframammary Fold Incision
Procedure: Lateral Radial Incision
Procedure: Inframammary Fold Incision or Lateral Radial Incision
Device: Laser-assisted fluorescence angiography
Drug: Indocyanine Green

Registration Number: NCT01969448

Lead Sponsor: Washington University School of Medicine

Brief Summary: The investigators hypothesize that nipple-areola skin sparing mastectomy (NASSM) performed through an inframammary incision has a superior blood supply relative to a lateral oblique incision. Moreover, by minimizing complications and optimizing aesthetic outcomes, the investigators believe it will be associated with significantly higher patient reported outcome scores. The addition of information gained by use of intraoperative laser-assisted fluorescent angiography (measured with the Spy Elite imaging device) will reduce complication rates by directing intraoperative resection of ischemic tissue and limiting the volume of immediate implant placement in instances where real time imaging would suggest compromised perfusion. These quantifiable, objective measures will justify the use of NASSM and immediate implant placement coupled with intraoperative laser-assisted fluorescent angiography in prosthetic based breast reconstruction despite longer operative times.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 79

Inclusion Criteria

Patient must be scheduled to undergo either a single or bilateral elective nipple-areola skin sparing mastectomy (NASSM) procedure with planned immediate reconstruction.
Patient must be 18 years of age or older.
Karnofsky Performance Scale of at least 80%.
Patient must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria

Cognitive impairment.
BMI < 18 or > 35
Breast >800 grams or <100 grams in predicted weight. "Breast" includes the breast tissue and in cases where the patient already has cosmetic breast implants, the additional breast implant mass. The sum total must be >100 g and <800 g.
History of radiation to the chest wall or breast being studied
Patients who have a history of allergy to iodides or iodinated contrast agents
Surgeon's opinion at the time of surgery that the subject's well-being would be compromised (e.g. significant comorbidities, intraoperative findings of a higher stage cancer or other independent acute health problems). If the contralateral breast is undergoing a nipple-sparing mastectomy with reconstruction as well, then the contralateral breast can be studied so long as there is no compromise to any element of their care.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inframammary Fold Incision Cohort	Inframammary Fold Incision	* Inframammary fold incision which is in the crease under the breast. * Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell) * Intraoperatively prior to mastectomy * At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet) * Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)
Inframammary Fold Incision Cohort	Laser-assisted fluorescence angiography	* Inframammary fold incision which is in the crease under the breast. * Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell) * Intraoperatively prior to mastectomy * At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet) * Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)
Lateral Radial Incision Cohort	Lateral Radial Incision	* Lateral radial incision * Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell) * Intraoperatively prior to mastectomy * At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet) * Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)
Lateral Radial Incision Cohort	Laser-assisted fluorescence angiography	* Lateral radial incision * Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell) * Intraoperatively prior to mastectomy * At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet) * Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)
Non-Randomized Cohort	Inframammary Fold Incision or Lateral Radial Incision	* Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort. * Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell) * Intraoperatively prior to mastectomy * At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet) * Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)
Non-Randomized Cohort	Laser-assisted fluorescence angiography	* Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort. * Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell) * Intraoperatively prior to mastectomy * At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet) * Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)
Inframammary Fold Incision Cohort	Indocyanine Green	* Inframammary fold incision which is in the crease under the breast. * Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell) * Intraoperatively prior to mastectomy * At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet) * Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)
Lateral Radial Incision Cohort	Indocyanine Green	* Lateral radial incision * Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell) * Intraoperatively prior to mastectomy * At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet) * Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)
Non-Randomized Cohort	Indocyanine Green	* Patients in which the surgeon feels that for oncologic reasons must have a specific incision (either inframammary fold or lateral radial incision) and cannot be randomized due to concerns of compromising clinical care but otherwise meet the inclusion and exclusion criteria will be offered participation as part of a non-randomized cohort. * Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell) * Intraoperatively prior to mastectomy * At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet) * Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)

Primary Outcome Measures

Name	Time	Method
Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy	At the time of surgery (day 1)	* Laser-assisted fluorescent angiography via the Spy Elite imaging device will be utilized to capture this data during mastectomy and immediate breast reconstruction. Standard postoperative patient follow up will assess for perfusion. * The Spy device quantifies perfusion by measuring relative fluorescence of indocyanine green bound to plasma proteins. This produces an intensity value of 0-255 based on an 8-bit greyscale. The investigators measured this value preoperatively when measured and compared to the post-intervention measurement. The device can calculate the cumulative intensity of a defined region of interest which the investigators categorized as the lateral, lower, medial, or nipple-areola region of the breast. The investigators also evaluated the cumulative value of these areas in total. Rate of perfusion was simply this value over time (90 seconds).
Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction	At the time of surgery (day 1)	* Laser-assisted fluorescent angiography via the Spy Elite imaging device will be utilized to capture this data during mastectomy and immediate breast reconstruction. Standard postoperative patient follow up will assess for perfusion. * The Spy device quantifies perfusion by measuring relative fluorescence of indocyanine green bound to plasma proteins. This produces an intensity value of 0-255 based on an 8-bit greyscale. The investigators measured this value preoperatively when measured and compared to the post-intervention measurement. The device can calculate the cumulative intensity of a defined region of interest which the investigators categorized as the lateral, lower, medial, or nipple-areola region of the breast. The investigators also evaluated the cumulative value of these areas in total. Rate of perfusion was simply this value over time (90 seconds).

Secondary Outcome Measures

Name	Time	Method
Breast Weight	At time of surgery (day 1)
Breast Q Score	Up to 3 months post permanent implant placement	-The BREAST-Q is a previously validated instrument which measures patient reported outcomes. It has several iterations including the one utilized here which is specific for implant-based breast reconstruction. Each of its 6 domains generates a Q-score from 0 (lowest) to 100 (highest). A higher number indicates a higher satisfaction or better quality of life than a lower number. Based on answers to the questions, each individual will generate a whole number score for each domain. The patient can be sampled preoperatively and postoperatively as well as over time to calculate the impact of intervention and time on this value. Q-scores are calculated for each domain, and the investigators report a mean value based on data from an entire cohort for the particular domain. Domains include evaluation of overall satisfaction with breasts, physical well being, sexual well being, as well as satisfaction with office staff, information provided, and the provider.
Number of Participants With Tissue Expander	Up to 3 months post permanent implant placement
Mean Operative Times for Mastectomy	At the time of surgery (day 1)