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

NCT01969448 | Completed Results DMC FDA Device

• 1 other identifier: 201302004
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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).

  At the time of surgery (day 1)

• 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).

  At the time of surgery (day 1)

Secondary Outcomes (4)

• Breast Q Score

  Up to 3 months post permanent implant placement

• 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)

Study Arms (3)

Inframammary Fold Incision Cohort

ACTIVE COMPARATOR

* 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; Drug: Indocyanine Green

Lateral Radial Incision Cohort

ACTIVE COMPARATOR

* 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; Drug: Indocyanine Green

Non-Randomized Cohort

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. * 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; Drug: Indocyanine Green

Interventions

Inframammary Fold Incision or Lateral Radial Incision PROCEDURE

Non-Randomized Cohort

Lateral Radial Incision PROCEDURE

Lateral Radial Incision Cohort

Inframammary Fold Incision PROCEDURE

Inframammary Fold Incision Cohort

Laser-assisted fluorescence angiography DEVICE

Also known as: Spy Elite, LifeCell.

Inframammary Fold Incision Cohort; Lateral Radial Incision Cohort; Non-Randomized Cohort

Indocyanine Green DRUG

Inframammary Fold Incision Cohort; Lateral Radial Incision Cohort; Non-Randomized Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• LifeCell: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (18)

• Kim HJ, Park EH, Lim WS, Seo JY, Koh BS, Lee TJ, Eom JS, Lee SW, Son BH, Lee JW, Ahn SH. Nipple areola skin-sparing mastectomy with immediate transverse rectus abdominis musculocutaneous flap reconstruction is an oncologically safe procedure: a single center study. Ann Surg. 2010 Mar;251(3):493-8. doi: 10.1097/SLA.0b013e3181c5dc4e.

  PMID: 20134317 BACKGROUND

• Cense HA, Rutgers EJ, Lopes Cardozo M, Van Lanschot JJ. Nipple-sparing mastectomy in breast cancer: a viable option? Eur J Surg Oncol. 2001 Sep;27(6):521-6. doi: 10.1053/ejso.2001.1130.

  PMID: 11520082 BACKGROUND

• Paepke S, Schmid R, Fleckner S, Paepke D, Niemeyer M, Schmalfeldt B, Jacobs VR, Kiechle M. Subcutaneous mastectomy with conservation of the nipple-areola skin: broadening the indications. Ann Surg. 2009 Aug;250(2):288-92. doi: 10.1097/SLA.0b013e3181b0c7d8.

  PMID: 19638905 BACKGROUND

• de Alcantara Filho P, Capko D, Barry JM, Morrow M, Pusic A, Sacchini VS. Nipple-sparing mastectomy for breast cancer and risk-reducing surgery: the Memorial Sloan-Kettering Cancer Center experience. Ann Surg Oncol. 2011 Oct;18(11):3117-22. doi: 10.1245/s10434-011-1974-y. Epub 2011 Aug 17.

  PMID: 21847697 BACKGROUND

• Salzberg CA, Ashikari AY, Koch RM, Chabner-Thompson E. An 8-year experience of direct-to-implant immediate breast reconstruction using human acellular dermal matrix (AlloDerm). Plast Reconstr Surg. 2011 Feb;127(2):514-524. doi: 10.1097/PRS.0b013e318200a961.

  PMID: 21285756 BACKGROUND

• Sacchini V, Pinotti JA, Barros AC, Luini A, Pluchinotta A, Pinotti M, Boratto MG, Ricci MD, Ruiz CA, Nisida AC, Veronesi P, Petit J, Arnone P, Bassi F, Disa JJ, Garcia-Etienne CA, Borgen PI. Nipple-sparing mastectomy for breast cancer and risk reduction: oncologic or technical problem? J Am Coll Surg. 2006 Nov;203(5):704-14. doi: 10.1016/j.jamcollsurg.2006.07.015. Epub 2006 Sep 11.

  PMID: 17084333 BACKGROUND

• Palmieri B, Baitchev G, Grappolini S, Costa A, Benuzzi G. Delayed nipple-sparing modified subcutaneous mastectomy: rationale and technique. Breast J. 2005 May-Jun;11(3):173-8. doi: 10.1111/j.1075-122X.2005.21520.x.

  PMID: 15871701 BACKGROUND

• Gerber B, Krause A, Dieterich M, Kundt G, Reimer T. The oncological safety of skin sparing mastectomy with conservation of the nipple-areola complex and autologous reconstruction: an extended follow-up study. Ann Surg. 2009 Mar;249(3):461-8. doi: 10.1097/SLA.0b013e31819a044f.

  PMID: 19247035 BACKGROUND

• Tepper OM, Karp NS, Small K, Unger J, Rudolph L, Pritchard A, Choi M. Three-dimensional imaging provides valuable clinical data to aid in unilateral tissue expander-implant breast reconstruction. Breast J. 2008 Nov-Dec;14(6):543-50. doi: 10.1111/j.1524-4741.2008.00645.x.

  PMID: 19054001 BACKGROUND

• Lista F, Ahmad J. Vertical scar reduction mammaplasty: a 15-year experience including a review of 250 consecutive cases. Plast Reconstr Surg. 2006 Jun;117(7):2152-65; discussion 2166-9. doi: 10.1097/01.prs.0000218173.16272.6c.

  PMID: 16772910 BACKGROUND

• Garwood ER, Moore D, Ewing C, Hwang ES, Alvarado M, Foster RD, Esserman LJ. Total skin-sparing mastectomy: complications and local recurrence rates in 2 cohorts of patients. Ann Surg. 2009 Jan;249(1):26-32. doi: 10.1097/SLA.0b013e31818e41a7.

  PMID: 19106672 BACKGROUND

• Ashikari RH, Ashikari AY, Kelemen PR, Salzberg CA. Subcutaneous mastectomy and immediate reconstruction for prevention of breast cancer for high-risk patients. Breast Cancer. 2008;15(3):185-91. doi: 10.1007/s12282-008-0059-7.

  PMID: 18575951 BACKGROUND

• Gerber B, Krause A, Reimer T, Muller H, Kuchenmeister I, Makovitzky J, Kundt G, Friese K. Skin-sparing mastectomy with conservation of the nipple-areola complex and autologous reconstruction is an oncologically safe procedure. Ann Surg. 2003 Jul;238(1):120-7. doi: 10.1097/01.SLA.0000077922.38307.cd.

  PMID: 12832974 BACKGROUND

• Komorowska-Timek E, Gurtner GC. Intraoperative perfusion mapping with laser-assisted indocyanine green imaging can predict and prevent complications in immediate breast reconstruction. Plast Reconstr Surg. 2010 Apr;125(4):1065-1073. doi: 10.1097/PRS.0b013e3181d17f80.

  PMID: 20335859 BACKGROUND

• Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.

  PMID: 19897823 BACKGROUND

• Losken A, Zenn MR, Hammel JA, Walsh MW, Carlson GW. Assessment of zonal perfusion using intraoperative angiography during abdominal flap breast reconstruction. Plast Reconstr Surg. 2012 Apr;129(4):618e-624e. doi: 10.1097/PRS.0b013e3182450b16.

  PMID: 22456376 BACKGROUND

• Ashitate Y, Lee BT, Ngo LH, Laurence RG, Hutteman M, Oketokoun R, Lunsford E, Soo Choi H, Frangioni JV. Quantitative assessment of nipple perfusion with near-infrared fluorescence imaging. Ann Plast Surg. 2013 Feb;70(2):149-53. doi: 10.1097/SAP.0b013e31822f9af7.

  PMID: 21862913 BACKGROUND

• Odom EB, Parikh RP, Um G, Kantola SW, Cyr AE, Margenthaler JA, Tenenbaum MM, Myckatyn TM. Nipple-Sparing Mastectomy Incisions for Cancer Extirpation Prospective Cohort Trial: Perfusion, Complications, and Patient Outcomes. Plast Reconstr Surg. 2018 Jul;142(1):13-26. doi: 10.1097/PRS.0000000000004498.

  PMID: 29878989 DERIVED

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Study had randomized-controlled trial design with assignment to IMF or LR incision but during enrollment patients frequently withdrew from randomization due to patient/surgical oncology preference and/or preexisting scars precluding randomization.

Results Point of Contact

• Title: Marissa J. Tenebaum, M.D.
• Organization: Washington University School of Medicine

tenenbaumm@wustl.edu

314-996-8800

Study Officials

• Marissa J Tenenbaum, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 25, 2013
• Study Start: March 28, 2013
• Primary Completion: April 27, 2016
• Study Completion: April 17, 2017
• Last Updated: April 18, 2018
• Results First Posted: April 18, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)