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IORT (Intra-operative Radiation Therapy) in Early Stage Breast Cancer
NCT01988870 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat breast cancer at the time of surgery. Traditionally, the recommended treatment for early stage breast cancer is surgery to remove the tumor, followed by whole breast radiation therapy to decrease the chance of recurrence of the cancer. Whole breast radiation involves daily radiation treatments for 4-6 weeks and can be associated with damage to other tissues including the skin. Recent technological advances have made it possible to provide radiation treatment during the breast cancer surgical procedure. This procedure is called intraoperative radiation therapy (IORT). The University of Virginia has a unique IORT system which allows for the inclusion of cutting edge imaging technology into the IORT procedure in order to provide delivery of radiation directly to the needed areas and to avoid radiation to other tissues.
Conditions Studied
Interventions
- RADIATION Intra-operative Radiation Therapy (IORT)
Study Locations (1)
Virginia
- University of Virginia Health System — Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01988870
The ClinicalTrials.gov registry entry for NCT01988870 describes a study currently listed as completed. 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 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shayna Showalter, MD, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention — of which Intra-operative Radiation Therapy (IORT) 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: NCT01988870 reports 1 study location spanning 1 distinct geographic area — top geographies include Virginia. 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 NCT01988870 about?
NCT01988870 is a clinical study titled "IORT (Intra-operative Radiation Therapy) in Early Stage Breast Cancer". The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat breast cancer at the time of surgery. Traditionally, the recommended treatment for early stage breast cancer is surgery to remove the tumor, followed by whole breast radiation therapy to decrease t...
What is the current status of trial NCT01988870?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2013-12. Estimated completion is 2015-11.
What conditions does trial NCT01988870 study?
This clinical trial studies the following conditions: Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01988870?
The interventions under investigation include: Intra-operative Radiation Therapy (IORT) (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01988870?
This trial is sponsored by Shayna Showalter, MD, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01988870 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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