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ACTIVE NOT RECRUITING NA

Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction

NCT01208974 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a nipple-sparing mastectomy and immediate breast reconstruction.

Interventions

  • PROCEDURE Nipple-Sparing Mastectomy
  • PROCEDURE Breast Reconstruction
  • PROCEDURE Axillary Surgery
  • RADIATION Prophylactic Nipple-Areolar Complex RT

Study Locations (1)

Florida

  • University of Miami Sylvester Comprehensive Cancer Center — Miami

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2010-03-16
Est. Completion 2026-05-31
Phase NA

Sponsor

University of Miami

667 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01208974

The ClinicalTrials.gov registry entry for NCT01208974 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 667 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions — of which Nipple-Sparing Mastectomy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01208974 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01208974 about?

NCT01208974 is a clinical study titled "Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction". The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a nipple-sparing mastectomy and immediate breast reconstruction.

What is the current status of trial NCT01208974?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 21 participants. The study started on 2010-03-16. Estimated completion is 2026-05-31.

What conditions does trial NCT01208974 study?

This clinical trial studies the following conditions: Breast Cancer, Ductal Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01208974?

The interventions under investigation include: Nipple-Sparing Mastectomy (PROCEDURE), Breast Reconstruction (PROCEDURE), Axillary Surgery (PROCEDURE), Prophylactic Nipple-Areolar Complex RT (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01208974?

This trial is sponsored by University of Miami, which has 667 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01208974 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial