Sensory Testing for Breast Cancer Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new methods to improve sensation after breast surgery by connecting nerves to the nipple and areola. The goal is to determine if this technique enhances satisfaction with surgical outcomes, particularly regarding sensation. The study includes various groups, such as individuals undergoing gender-affirming mastectomy or breast reconstruction using implants or their own tissue. Suitable candidates for this trial are those planning to undergo one of these surgeries and who can provide informed consent. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Do I have to stop taking my current medications for the trial?
If you are currently taking medication that affects nerve regeneration or causes nerve damage, you may not be eligible for the trial. It's best to discuss your specific medications with the trial team.
What prior data suggests that these surgical reinnervation techniques are safe?
Research has shown that nipple-sparing mastectomy (NSM) with reconstruction using a patient's own tissue is safe for breast cancer surgery. Patients report good cosmetic results with few complications. For instance, tissue death around the nipple occurred in only about 8.2% of cases. Additionally, the chance of cancer returning in the treated area was low, around 2.38%.
Studies have also found that NSM with implant reconstruction is safe. In one study, only 9% of patients lost their implants shortly after surgery. Both methods, whether using implants or a person's own tissue, effectively control cancer and ensure overall survival.
For gender mastectomy with free nipple grafting, safety is similarly promising. A study found low complication rates. For example, the chance of developing a hematoma (a blood collection outside blood vessels) ranged from 0% to 31.2%, with most cases on the lower end. Infection rates were also low, ranging from 0% to 6.8%.
Overall, these surgical techniques are considered well-tolerated based on current research. They have a good safety profile with low risks of serious complications.12345Why are researchers excited about this trial?
Researchers are excited about these surgical techniques because they aim to improve sensation and satisfaction after mastectomy, which is a significant concern for cancer and transgender patients. Nipple sparing mastectomy (NSM) with either autologous or implant reconstruction is designed to preserve the nipple, potentially leading to better aesthetic and sensory outcomes compared to traditional mastectomy methods that do not preserve the nipple. Likewise, the gender mastectomy with free nipple grafting offers an alternative for transgender patients by focusing on reconstructive techniques that might enhance sensation and personal satisfaction. These approaches are being explored to better meet the diverse needs of patients, addressing both physical and emotional aspects of recovery.
What evidence suggests that this trial's surgical reinnervation techniques could be effective for improving postoperative sensation in breast surgery?
This trial will compare different surgical approaches for mastectomy. Studies have shown that nipple-sparing mastectomy (NSM) using a patient's own tissue for reconstruction, one of the approaches in this trial, leads to high patient satisfaction and is as safe as other breast surgeries. In over 1,000 cases, the chance of cancer returning in the same area was low, at about 3.7%, and most patients remained cancer-free for at least five years. Another approach in this trial, NSM with implant reconstruction, has been shown in research to enhance quality of life, improving body image and sexual well-being without increasing cancer-related stress.
For gender-affirming mastectomy with free nipple grafting, another treatment arm in this trial, studies suggest that reconnecting nerves can improve sensation and overall quality of life for transgender patients. This method has been found to be safe and effective, with many patients reporting better results and satisfaction with their surgery.678910Who Is on the Research Team?
Lisa Gfrerer, MD, PhD
Principal Investigator
Weill Medical College of Cornell University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Initial Recovery
Participants undergo mastectomy and reconstruction with or without reinnervation, followed by initial recovery
Postoperative Monitoring
Participants are monitored for sensory outcomes and patient satisfaction using QST and PROMs
Long-term Follow-up
Annual assessments of sensory outcomes and patient satisfaction using various tools
What Are the Treatments Tested in This Trial?
Interventions
- Surgical Reinnervation
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Nipple sparing mastectomy (NSM) and implant reconstruction
Nipple sparing mastectomy (NSM) and autologous reconstruction
Gender mastectomy with free nipple grafting
Control patients matched by surgical procedure, age, BMI and mastectomy weight.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
Massachusetts General Hospital
Collaborator
Citations
Targeted Reinnervation During Gender-Affirming ...
Improved surgical outcome with double incision and free nipple graft in gender confirmation mastectomy. Plast Reconstr Surg Glob Open ...
Targeted Reinnervation During Gender-Affirming ...
This cohort study evaluates the quantitative and patient-reported sensory outcomes of targeted reinnervation during gender-affirming mastectomy.
3.
journals.lww.com
journals.lww.com/annalsofsurgery/fulltext/2025/07000/prospective_sensory_outcomes_for_targeted.25.aspxProspective Sensory Outcomes for Targeted Nipple-areola...
Improved surgical outcome with double incision and free nipple graft in gender confirmation mastectomy. ... mastectomy and autologous breast reconstruction ...
Prospective assessment of the quality of life and nipple ...
Our prospective study confirms the significant improvement in the quality of life of transgender patients after chest gender-affirming surgery.
A case report of gender-affirming mastectomy in a transgender ...
Under nonpathological conditions, free nipple grafting is a safe and effective procedure to achieve patient cosmetic goals for GAM (17-19). Unfortunately, due ...
Surgical and patient-reported outcomes following double ...
Results: DIFNG mastectomies were performed in 97 patients from 2016 to 2019, of which 43(44%) were obese and 54(56%) were non-obese. The ...
Surgical and patient-reported outcomes following double ...
The rate of hematoma following gender-affirming mastectomy is reported in the literature ranging from 0% to 31.2%. The use of more limited, nipple-sparing ...
Mastectomy is a safe procedure in transgender men with a ...
Most individuals underwent a Wise-pattern breast reduction (91%) and a double incision mastectomy with free nipple grafts (86%). Following mastectomy, one acute ...
Nipple-areola complex reconstruction in transgender patients ...
Postoperative complications were low. The rate of breasts that presented hematoma varied between 0% to 18.2%, the rate of seroma from 0 to 6.8%, and infection ...
10.
journals.lww.com
journals.lww.com/annalsplasticsurgery/fulltext/2025/07000/comparative_outcome_study_of_gynecomastia_surgery.25.aspxComparative Outcome Study of Gynecomastia Surgery and...
The complication rate was 21%. Three patients (6%) developed hematomas. Five patients (9%) underwent revisions. No patient experienced complications of the ...
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