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

Primary Purpose

Ductal Carcinoma in Situ - Category, Breast Cancer, Prophylactic Mastectomy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Inframammary Fold Incision or Lateral Radial Incision

Lateral Radial Incision

Inframammary Fold Incision

Laser-assisted fluorescence angiography

Indocyanine Green

About this trial

This is an interventional treatment trial for Ductal Carcinoma in Situ - Category focused on measuring Nipple-areola skin sparing mastectomy, Immediate reconstruction, Prophylactic Mastectomy, Breast-Q, Breast Cancer, Ductal Carcinoma in Situ - Category

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Other

Arm Label

Inframammary Fold Incision Cohort

Lateral Radial Incision Cohort

Non-Randomized Cohort

Arm 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)

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)

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)

Outcomes

Primary Outcome Measures

Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy

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

Secondary Outcome Measures

Breast Q Score

-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

Mean Operative Times for Mastectomy

Breast Weight

Full Information

NCT ID

NCT01969448

First Posted

October 14, 2013

Last Updated

March 20, 2018

Sponsor

Washington University School of Medicine

Collaborators

LifeCell

1. Study Identification

Unique Protocol Identification Number

NCT01969448

Brief Title

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

Acronym

NASSM

Official Title

A Prospective Randomized Trial to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

March 28, 2013 (Actual)

Primary Completion Date

April 27, 2016 (Actual)

Study Completion Date

April 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

Collaborators

LifeCell

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ductal Carcinoma in Situ - Category, Breast Cancer, Prophylactic Mastectomy

Keywords

Nipple-areola skin sparing mastectomy, Immediate reconstruction, Prophylactic Mastectomy, Breast-Q, Breast Cancer, Ductal Carcinoma in Situ - Category

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inframammary Fold Incision Cohort

Arm Type

Active Comparator

Arm Description

Arm Title

Lateral Radial Incision Cohort

Arm Type

Active Comparator

Arm Description

Arm Title

Non-Randomized Cohort

Arm Type

Other

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Inframammary Fold Incision or Lateral Radial Incision

Intervention Type

Procedure

Intervention Name(s)

Lateral Radial Incision

Intervention Type

Procedure

Intervention Name(s)

Inframammary Fold Incision

Intervention Type

Device

Intervention Name(s)

Laser-assisted fluorescence angiography

Other Intervention Name(s)

Spy Elite, LifeCell.

Intervention Type

Drug

Intervention Name(s)

Indocyanine Green

Primary Outcome Measure Information:

Title

Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy

Description

Time Frame

At the time of surgery (day 1)

Title

Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction

Description

Time Frame

At the time of surgery (day 1)

Secondary Outcome Measure Information:

Title

Breast Q Score

Description

Time Frame

Up to 3 months post permanent implant placement

Title

Number of Participants With Tissue Expander

Time Frame

Up to 3 months post permanent implant placement

Title

Mean Operative Times for Mastectomy

Time Frame

At the time of surgery (day 1)

Title

Breast Weight

Time Frame

At time of surgery (day 1)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marissa J Tenenbaum, M.D.

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Links:

URL

http://www.siteman.wustl.edu

Description

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

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

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