Breast Cancer, Ductal Carcinoma in Situ - Category, Prophylactic Mastectomy
Conditions
Keywords
Nipple-areola skin sparing mastectomy, Immediate reconstruction, Prophylactic Mastectomy, Breast-Q, Breast Cancer, Ductal Carcinoma in Situ - Category
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.
Interventions
PROCEDUREInframammary Fold Incision or Lateral Radial Incision
PROCEDURELateral Radial Incision
PROCEDUREInframammary Fold Incision
DEVICELaser-assisted fluorescence angiography
DRUGIndocyanine Green
Sponsors
LifeCell
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy | 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). |
| Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction | 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
| Measure | Time frame | Description |
|---|---|---|
| Breast Q Score | 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. |
| Number of Participants With Tissue Expander | Up to 3 months post permanent implant placement | — |
| Mean Operative Times for Mastectomy | At the time of surgery (day 1) | — |
| Breast Weight | At time of surgery (day 1) | — |
Countries
United States
Participant flow
Recruitment details
Enrollment to the study opened to enrollment 03/28/2013 and closed to enrollment on 03/09/2016.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 55 |
| 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) | 24 |
| 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) | 0 |
| Total | 79 |
Baseline characteristics
| Characteristic | Inframammary Fold Incision Cohort | Lateral Radial Incision Cohort | Total | Non-Randomized Cohort |
|---|---|---|---|---|
| Age, Continuous | 43.2 years STANDARD_DEVIATION 10.8 | 46.6 years STANDARD_DEVIATION 10.5 | 44.2 years STANDARD_DEVIATION 10.7 | — |
| Region of Enrollment United States | 55 participants | 24 participants | 79 participants | — |
| Sex: Female, Male Female | 55 Participants | 24 Participants | 79 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 55 | 0 / 24 | 0 / 0 |
| serious Total, serious adverse events | 0 / 55 | 0 / 24 | 0 / 0 |
Outcome results
Primary
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).
Time frame: At the time of surgery (day 1)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Inframammary Fold Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy | Nipple | 29.9 percentage of original preop perfusion |
| Inframammary Fold Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy | Lateral | 73.5 percentage of original preop perfusion |
| Inframammary Fold Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy | Inferior | 54.6 percentage of original preop perfusion |
| Inframammary Fold Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy | Medial | 62.5 percentage of original preop perfusion |
| Inframammary Fold Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy | Overall breast | 63.9 percentage of original preop perfusion |
| Lateral Radial Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy | Medial | 65.2 percentage of original preop perfusion |
| Lateral Radial Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy | Overall breast | 60.8 percentage of original preop perfusion |
| Lateral Radial Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy | Nipple | 40.0 percentage of original preop perfusion |
| Lateral Radial Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy | Inferior | 72.0 percentage of original preop perfusion |
| Lateral Radial Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy | Lateral | 76.5 percentage of original preop perfusion |
Primary
Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction
* 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).
Time frame: At the time of surgery (day 1)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Inframammary Fold Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction | Inferior | 21.9 percentage of original preop perfusion |
| Inframammary Fold Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction | Lateral | 23.01 percentage of original preop perfusion |
| Inframammary Fold Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction | Medial | 28.0 percentage of original preop perfusion |
| Inframammary Fold Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction | Overall breast | 30.6 percentage of original preop perfusion |
| Inframammary Fold Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction | Nipple | 23.2 percentage of original preop perfusion |
| Lateral Radial Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction | Overall breast | 35.1 percentage of original preop perfusion |
| Lateral Radial Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction | Lateral | 40.7 percentage of original preop perfusion |
| Lateral Radial Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction | Nipple | 31.3 percentage of original preop perfusion |
| Lateral Radial Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction | Inferior | 36.9 percentage of original preop perfusion |
| Lateral Radial Incision Cohort | Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction | Medial | 32.1 percentage of original preop perfusion |
Secondary
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.
Time frame: Up to 3 months post permanent implant placement
Population: 6 participants were not evaluable for this outcome measure in the inframammary fold incision cohort and 2 particpants were not evaluable for this outcome measure in the lateral radial incision cohort due to not completing the Breast Q score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inframammary Fold Incision Cohort | Breast Q Score | Sexuality (post-op) | 68.7 units on a scale | Standard Deviation 25.3 |
| Inframammary Fold Incision Cohort | Breast Q Score | Satisfaction with Breasts (post-op) | 69.3 units on a scale | Standard Deviation 21.8 |
| Inframammary Fold Incision Cohort | Breast Q Score | Psychosocial (pre-op) | 74.1 units on a scale | Standard Deviation 16.5 |
| Inframammary Fold Incision Cohort | Breast Q Score | Psychosocial (post-op) | 79.8 units on a scale | Standard Deviation 19.8 |
| Inframammary Fold Incision Cohort | Breast Q Score | Physical chest (pre-op) | 88.3 units on a scale | Standard Deviation 14 |
| Inframammary Fold Incision Cohort | Breast Q Score | Physical chest (post-op) | 77.9 units on a scale | Standard Deviation 12.4 |
| Inframammary Fold Incision Cohort | Breast Q Score | Sexuality (pre-op) | 59.4 units on a scale | Standard Deviation 10.3 |
| Inframammary Fold Incision Cohort | Breast Q Score | Satisfaction with Breasts (pre-op) | 62.1 units on a scale | Standard Deviation 17.3 |
| Lateral Radial Incision Cohort | Breast Q Score | Physical chest (pre-op) | 85.7 units on a scale | Standard Deviation 12.2 |
| Lateral Radial Incision Cohort | Breast Q Score | Satisfaction with Breasts (pre-op) | 53.8 units on a scale | Standard Deviation 13.1 |
| Lateral Radial Incision Cohort | Breast Q Score | Psychosocial (post-op) | 85.2 units on a scale | Standard Deviation 17 |
| Lateral Radial Incision Cohort | Breast Q Score | Physical chest (post-op) | 83.4 units on a scale | Standard Deviation 12.4 |
| Lateral Radial Incision Cohort | Breast Q Score | Psychosocial (pre-op) | 68.0 units on a scale | Standard Deviation 12.9 |
| Lateral Radial Incision Cohort | Breast Q Score | Sexuality (pre-op) | 56.7 units on a scale | Standard Deviation 10.8 |
| Lateral Radial Incision Cohort | Breast Q Score | Sexuality (post-op) | 68.6 units on a scale | Standard Deviation 17.2 |
| Lateral Radial Incision Cohort | Breast Q Score | Satisfaction with Breasts (post-op) | 68.7 units on a scale | Standard Deviation 12 |
Secondary
Breast Weight
Time frame: At time of surgery (day 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inframammary Fold Incision Cohort | Breast Weight | 350 grams | Standard Deviation 156 |
| Lateral Radial Incision Cohort | Breast Weight | 418 grams | Standard Deviation 151 |
Secondary
Mean Operative Times for Mastectomy
Time frame: At the time of surgery (day 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inframammary Fold Incision Cohort | Mean Operative Times for Mastectomy | 155.3 minutes | Standard Deviation 41.2 |
| Lateral Radial Incision Cohort | Mean Operative Times for Mastectomy | 177.0 minutes | Standard Deviation 29 |
Secondary
Number of Participants With Tissue Expander
Time frame: Up to 3 months post permanent implant placement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inframammary Fold Incision Cohort | Number of Participants With Tissue Expander | 19 Participants |
| Lateral Radial Incision Cohort | Number of Participants With Tissue Expander | 12 Participants |