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

The Washington University

Status: Completed

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

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01969448

201302004

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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79 participants in 3 patient groups

Inframammary Fold Incision Cohort

Active Comparator group

Description:

* 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)

Treatment:

Device: Laser-assisted fluorescence angiography

Drug: Indocyanine Green

Procedure: Inframammary Fold Incision

Lateral Radial Incision Cohort

Active Comparator group

Description:

* 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)

Treatment:

Procedure: Lateral Radial Incision

Device: Laser-assisted fluorescence angiography

Drug: Indocyanine Green

Non-Randomized Cohort

Other group

Description:

* 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)

Treatment:

Procedure: Inframammary Fold Incision or Lateral Radial Incision

Device: Laser-assisted fluorescence angiography

Drug: Indocyanine Green