Overview

This trial is active, not recruiting.

Conditions ductal carcinoma in situ - category, breast cancer, prophylactic mastectomy
Treatments inframammary fold incision or lateral radial incision, lateral radial incision, inframammary fold incision, laser-assisted fluorescence angiography
Sponsor Washington University School of Medicine
Collaborator LifeCell
Start date March 2013
End date March 2017
Trial size 83 participants
Trial identifier NCT01969448, 201302004

Summary

The primary hypothesis of this study is to determine which of two incision sites (inframammary fold incision or the lateral radial incision) provides a more robust blood supply to the skin envelope during nipple-sparing mastectomy with immediate reconstruction.

Following education about the trial and informed consent, patients will be randomized to one of the two incisions. If their surgeon recommends a particular incision, there is also a non-randomized cohort. Patients will complete the Breast Q, a questionnaire prior to surgery and three months after surgery to capture quality of life data. During the surgery, laser-assisted fluorescent angiography will be performed three times to look at blood perfusion with the Spy Elite imaging device.

Patients will be required to return for postoperative follow up visits. All patients will be seen approximately one week, three weeks, and six weeks after surgery. Patients with a direct implant will finish the study at their three month post-operative visit. Patients with an expander will finish the study three months after their final implant is placed.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients in this cohort will be randomized to the inframammary fold incision which is in the crease under the breast. Goal: 28 Patients
inframammary fold incision
laser-assisted fluorescence angiography Spy Elite, LifeCell.
All study arms will utilize this device to evaluate breast perfusion just prior to mastectomy, at the conclusion of the mastectomy procedure, and following conclusion of reconstruction and immediate implant.
(Active Comparator)
Patients will be randomized to the lateral radial incision. Goal: 28 Patients
lateral radial incision
laser-assisted fluorescence angiography Spy Elite, LifeCell.
All study arms will utilize this device to evaluate breast perfusion just prior to mastectomy, at the conclusion of the mastectomy procedure, and following conclusion of reconstruction and immediate implant.
(Other)
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. Goal: 28 Patients
inframammary fold incision or lateral radial incision
laser-assisted fluorescence angiography Spy Elite, LifeCell.
All study arms will utilize this device to evaluate breast perfusion just prior to mastectomy, at the conclusion of the mastectomy procedure, and following conclusion of reconstruction and immediate implant.

Primary Outcomes

Measure
Robust blood supply to skin envelope during mastectomy and reconstruction
time frame: Up to 4 years.

Secondary Outcomes

Measure
Breast Q and Q-score
time frame: Up to 4 years.

Eligibility Criteria

Female participants at least 18 years old.

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. - Karnofsky Performance Scale of at least 80%. Exclusion Criteria: - BMI < 18 or > 35 - Breast tissue of > 800 grams or < 100 grams in weight - History of radiation to the chest wall or breast being studied - History of allergy to iodides or iodinated contrast agents - Cognitive impairment - 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).

Additional Information

Official title A Prospective Randomized Trial to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction
Principal investigator Marissa J Tenenbaum, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.
Location data was received from the National Cancer Institute and was last updated in June 2016.