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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Washington University School of Medicine
Sponsor:
Collaborator:
LifeCell
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01969448
First received: October 14, 2013
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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: one week, three weeks, six weeks, and three months.


Condition Intervention
Ductal Carcinoma in Situ (DCIS)
Clinical Stage I Breast Cancer
Prophylactic Mastectomy
Procedure: Inframammary Fold Incision or Lateral Radial Incision
Procedure: Lateral Radial Incision
Procedure: Inframammary Fold Incision
Device: Laser-assisted fluorescence angiography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Robust blood supply to skin envelope during mastectomy and reconstruction [ Time Frame: Up to 4 years. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Breast Q and Q-score [ Time Frame: Up to 4 years. ] [ Designated as safety issue: No ]
    Which approach to nipple-areola skin-sparing mastectomy renders the most favorable patient reported outcomes during the Breast Q and Q-score?


Estimated Enrollment: 84
Study Start Date: March 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Inframammary Fold Incision Cohort

Patients in this cohort will be randomized to the inframammary fold incision which is in the crease under the breast.

Goal: 28 Patients

Procedure: Inframammary Fold Incision Device: Laser-assisted fluorescence angiography
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 Name: Spy Elite, LifeCell.
Active Comparator: Lateral Radial Incision Cohort
Patients will be randomized to the lateral radial incision. Goal: 28 Patients
Procedure: Lateral Radial Incision Device: Laser-assisted fluorescence angiography
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 Name: Spy Elite, LifeCell.
Non-Randomized Cohort

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

Procedure: Inframammary Fold Incision or Lateral Radial Incision Device: Laser-assisted fluorescence angiography
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 Name: Spy Elite, LifeCell.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 for prophylaxis, ductal carcinoma in site (DCIS), or clinical Stage I breast cancer.
  • Karnofsky Performance Scale of at least 80%.

Exclusion Criteria:

  • BMI < 20 or > 30
  • Breast tissue of > 600 grams or < 100 grams in weight
  • History of lumpectomy (needle biopsies are eligible)
  • History of radiation to the chest wall or breasts
  • History of allergy to iodides or iodinated contrast agents
  • History of previous breast surgery other than primary cosmetic augmentation
  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01969448

Contacts
Contact: Colleen Kilbourne, MA 314-996-3873 kilbournec@wudosis.wustl.edu

Locations
United States, Missouri
West County Plastic Surgeons of Washington University Recruiting
St. Louis, Missouri, United States, 63141
Principal Investigator: Marissa J Tenenbaum, MD         
Sub-Investigator: Terence M Myckatyn, MD, FACS, FRCSC         
Sub-Investigator: Julie A Margenthaler, MD         
Sponsors and Collaborators
Washington University School of Medicine
LifeCell
Investigators
Principal Investigator: Marissa J Tenenbaum, MD Washington University Early Recognition Center
  More Information

Additional Information:
Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01969448     History of Changes
Other Study ID Numbers: 201302004
Study First Received: October 14, 2013
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Nipple-areola skin sparing mastectomy
Immediate reconstruction
Prophylactic Mastectomy
Breast-Q
Clinical Stage I Breast Cancer
Ductal Carcinoma in Situ

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Carcinoma, Ductal
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on September 14, 2014