Ductal Carcinoma in Situ - CategoryNASSMNCT01969448

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

A study testing Inframammary Fold Incision or Lateral Radial Incision, Lateral Radial Incision and Inframammary Fold Incision in people with Ductal Carcinoma in Situ - Category and Breast Cancer, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Ductal Carcinoma in Situ - Category, Breast Cancer, Prophylactic Mastectomy
What is being tested?: Inframammary Fold Incision or Lateral Radial Incision, Lateral Radial Incision and Inframammary Fold Incision
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: 1 siteUnited States
Study dates: 28 Mar 2013to 17 Apr 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

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

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
Being tested: Inframammary Fold Incision or Lateral Radial Incision, Lateral Radial Incision, Inframammary Fold Incision, Laser-assisted fluorescence angiography, Indocyanine Green
Keywords: Nipple-areola skin sparing mastectomy, Immediate reconstruction, Prophylactic Mastectomy, Breast-Q, Breast Cancer, Ductal Carcinoma in Situ - Category
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inframammary Fold Incision or Lateral Radial IncisionProcedure or surgery
Lateral Radial IncisionProcedure or surgery
Inframammary Fold IncisionProcedure or surgery
Laser-assisted fluorescence angiographyDevice
Also called Spy Elite, LifeCell.
Indocyanine GreenDrug

Study groups in NCT01969448
Study group	Role	What they receive
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) Receives: 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) Receives: 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) Receives: Procedure: Inframammary Fold Incision or Lateral Radial Incision; Device: Laser-assisted fluorescence angiography; Drug: Indocyanine Green

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: At the time of surgery (day 1)

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 201317 Apr 2017

First posted25 Oct 2013 (estimated)
Study start28 Mar 2013
Primary completion27 Apr 2016
Study completion17 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Ductal Carcinoma in Situ - CategoryStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01969448
Sponsor's protocol ID: 201302004
Acronym: NASSM
Status last verified: Mar 2018
First submitted: 14 Oct 2013
Last updated: 18 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 20134317
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.
PubMed 11520082
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.
PubMed 19638905
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.
PubMed 21847697
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.
PubMed 21285756
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.
PubMed 17084333
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.
PubMed 15871701
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.
PubMed 19247035
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.
PubMed 19054001
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.
PubMed 16772910
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.
PubMed 19106672
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.
PubMed 18575951
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.
PubMed 12832974
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.
PubMed 20335859
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.
PubMed 19897823

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Randomized Trial to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction
ClinicalTrials.gov ID: NCT01969448
Acronym / sponsor ID: NASSM / 201302004
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: LifeCell
Study start: 28 Mar 2013 (actual)
Primary completion: 27 Apr 2016 (actual)
Study completion: 17 Apr 2017 (actual)
First posted: 25 Oct 2013 (estimated)
Results: Posted 18 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Inframammary Fold Incision Cohort	Active comparator	Procedure: Inframammary Fold Incision, Device: Laser-assisted fluorescence angiography, Drug: Indocyanine Green* 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 Cohort	Active comparator	Procedure: Lateral Radial Incision, Device: Laser-assisted fluorescence angiography, Drug: Indocyanine Green* 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)
Non-Randomized Cohort	Other	Procedure: Inframammary Fold Incision or Lateral Radial Incision, Device: Laser-assisted fluorescence angiography, Drug: Indocyanine Green* 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)

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Inframammary Fold Incision or Lateral Radial Incision	Procedure or surgery	Non-Randomized Cohort
Lateral Radial Incision	Procedure or surgery	Lateral Radial Incision Cohort
Inframammary Fold Incision	Procedure or surgery	Inframammary Fold Incision Cohort
Laser-assisted fluorescence angiographyAlso: Spy Elite, LifeCell.	Device	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

Primary outcome

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).
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).

4 secondary outcomes

Breast Q Score
Time frame: Up to 3 months post permanent implant placement
Number of Participants With Tissue Expander
Time frame: Up to 3 months post permanent implant placement
Mean Operative Times for Mastectomy
Time frame: At the time of surgery (day 1)
Breast Weight
Time frame: At time of surgery (day 1)

Results and safety

Results posted to the registry on 18 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Inframammary Fold Incision Cohort	55	55
Lateral Radial Incision Cohort	24	24
Non-Randomized Cohort	0	0

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

Time frame: At the time of surgery (day 1). Number. Unit: percentage of original preop perfusion

Measure	Inframammary Fold Incision Cohort n = 55	Lateral Radial Incision Cohort n = 24	Non-Randomized Cohort n = 0
Overall breast	63.9	60.8	–
Nipple	29.9	40.0	–
Inferior	54.6	72.0	–
Lateral	73.5	76.5	–
Medial	62.5	65.2	–

Primary outcome: Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction

Time frame: At the time of surgery (day 1). Number. Unit: percentage of original preop perfusion

Measure	Inframammary Fold Incision Cohort n = 55	Lateral Radial Incision Cohort n = 24	Non-Randomized Cohort n = 0
Overall breast	30.6	35.1	–
Nipple	23.2	31.3	–
Inferior	21.9	36.9	–
Lateral	23.01	40.7	–
Medial	28.0	32.1	–

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Inframammary Fold Incision Cohort	0 of 55 (0%)	0 of 55 (0%)	Not reported
Lateral Radial Incision Cohort	0 of 24 (0%)	0 of 24 (0%)	Not reported
Non-Randomized Cohort	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20134317Kim 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.
Background: PubMed 11520082Cense 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.
Background: PubMed 19638905Paepke 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.
Background: PubMed 21847697de 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.
Background: PubMed 21285756Salzberg 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.
Background: PubMed 17084333Sacchini 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.
Background: PubMed 15871701Palmieri 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.
Background: PubMed 19247035Gerber 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.
Background: PubMed 19054001Tepper 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.
Background: PubMed 16772910Lista 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.
Background: PubMed 19106672Garwood 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.
Background: PubMed 18575951Ashikari 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.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marissa J Tenenbaum, M.D. principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy (time frame: At the time of surgery (day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01969448, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.