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

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ClinicalTrials.gov Identifier: NCT01969448
Recruitment Status : Completed
First Posted : October 25, 2013
Results First Posted : April 18, 2018
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
LifeCell
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ductal Carcinoma in Situ - Category 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 Drug: Indocyanine Green Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction
Actual Study Start Date : March 28, 2013
Actual Primary Completion Date : April 27, 2016
Actual Study Completion Date : April 17, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Inframammary Fold Incision Cohort
  • 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)
Procedure: Inframammary Fold Incision Device: Laser-assisted fluorescence angiography
Other Name: Spy Elite, LifeCell.
Drug: Indocyanine Green
Active Comparator: Lateral Radial Incision Cohort
  • 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)
Procedure: Lateral Radial Incision Device: Laser-assisted fluorescence angiography
Other Name: Spy Elite, LifeCell.
Drug: Indocyanine Green
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.
  • 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)
Procedure: Inframammary Fold Incision or Lateral Radial Incision Device: Laser-assisted fluorescence angiography
Other Name: Spy Elite, LifeCell.
Drug: Indocyanine Green



Primary Outcome Measures :
  1. Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy [ Time Frame: 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).

  2. Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction [ Time Frame: 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 :
  1. Breast Q Score [ Time Frame: 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.

  2. Number of Participants With Tissue Expander [ Time Frame: Up to 3 months post permanent implant placement ]
  3. Mean Operative Times for Mastectomy [ Time Frame: At the time of surgery (day 1) ]
  4. Breast Weight [ Time Frame: At time of surgery (day 1) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969448


Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
LifeCell
Investigators
Principal Investigator: Marissa J Tenenbaum, M.D. Washington University School of Medicine

Additional Information:
Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01969448     History of Changes
Other Study ID Numbers: 201302004
First Posted: October 25, 2013    Key Record Dates
Results First Posted: April 18, 2018
Last Update Posted: April 18, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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

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