Areola Preservation in Nipple-Sparing Mastectomy With Nipple Involvement
Summary
NIH registered a new pilot clinical trial (NCT07544134) titled 'Areola Preservation in NSM With Nipple Involvement' on ClinicalTrials.gov, with an anticipated date of April 22, 2026. The single-arm, single-center prospective study will enroll women with early-stage breast cancer undergoing nipple-sparing mastectomy, conditionally enrolling them into an areola-preservation protocol only if intraoperative frozen section confirms nipple involvement. The intervention involves nipple removal, immediate second frozen section of sub-areolar tissue, areola preservation if cancer-negative, and immediate nipple reconstruction using a local skin flap.
“Currently, there is no prospective study to guide whether the areola can be safely preserved in this specific situation.”
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What changed
NIH registered a new prospective exploratory clinical trial on ClinicalTrials.gov. The study will test a surgical protocol for conditionally preserving the areola during nipple-sparing mastectomy when the nipple is found to contain cancer on intraoperative frozen section. Women meeting eligibility criteria will be enrolled conditionally: the nipple is removed, sub-areolar tissue is tested by second frozen section, and the areola is preserved only if this additional margin is cancer-negative, followed by immediate nipple reconstruction.
Healthcare institutions and breast cancer research programs conducting nipple-sparing mastectomy procedures may wish to review this protocol as a potential future reference for managing intraoperative nipple involvement findings. The study's outcome data on feasibility, safety, and early cosmetic outcomes could inform future surgical practice guidelines.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Areola Preservation in NSM With Nipple Involvement
N/A NCT07544134 Kind: NA Apr 22, 2026
Abstract
Background:
During nipple-sparing mastectomy (a surgery that removes breast tissue but keeps the nipple and areola), doctors test the tissue behind the nipple right away. If cancer cells are found in this nipple tissue, current guidelines say the entire nipple and areola must be removed. However, research suggests that when the nipple is involved, the surrounding pigmented skin (the areola) is very rarely affected by cancer. Removing it might be unnecessary and leads to a worse cosmetic outcome, which can impact a woman's self-image and quality of life. Currently, there is no prospective study to guide whether the areola can be safely preserved in this specific situation.
Purpose:
This is a pilot study that aims to explore the feasibility, safety, and early outcomes of a new surgical procedure: preserving the areola and performing immediate nipple reconstruction when cancer is found in the nipple during surgery.
Study Plan:
This is a single-arm, single-center, prospective, exploratory study. Women with early-stage breast cancer who are scheduled for a nipple-sparing mastectomy will be invited. Only if cancer is confirmed in the nipple during their surgery will they be enrolled into the single test group. In this group:
The nipple is removed.
A small ring of tissue from under the areola is tested immediately (second frozen section). If this ring shows no cancer, the areola skin is preserved.
A new nipple is created during the same operation using a local skin flap t...
Conditions: Breast Cancer, Ductal Carcinoma In Situ, DCIS, Invasive Breast Carcinoma
Interventions: Areola-Preserving Nipple-Sparing Mastectomy with Immediate Nipple Reconstruction
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