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NCT02701244 · ClinicalTrials.gov registry record
A Registry Study of Breast Microseed Treatment
A clinical trial of Breast Neoplasms, sponsored by Concure Oncology-Breast Microseed.
- Recruiting
- Registry status
- 420
- Enrollment target
- 3
- Study locations
NCT02701244 is a study of Breast Neoplasms that is actively recruiting participants, run by Concure Oncology-Breast Microseed. The registered enrollment target is 420 participants, below the 565-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (26% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT02701244, a study of Breast Neoplasms, is actively recruiting participants, sponsored by Concure Oncology-Breast Microseed.
- RECRUITING
- Registry status
- 420 participants
- Enrollment target
- 3
- Study locations
Study Summary
For women diagnosed with early stage breast cancer, lumpectomy followed by radiation is a common treatment option. Radiation treatment is typically delivered to the whole breast, five times per week, for anywhere from 3 to 8 weeks. The radiation helps kill any cancer cells that may have been left over following the surgery but causes skin burns. Many studies have demonstrated that radiation to the whole breast is not necessary, that it can be delivered to a portion of the breast where the cancer is more likely to recur. A technique called a Permanent Breast Seed Implant (PBSI) involving the implantation of radioactive seeds has been developed to deliver the radiation to a portion of the breast. The procedure is performed on an out-patient basis under local anesthesia and light sedation. Because the radioactive seeds are permanently implanted in the breast, the patient is able to live a normal life while the seeds deliver the prescribed radiation to the breast. Previous studies on PBSI demonstrate that it is a safe and effective alternative form of radiation for appropriately selected patients after lumpectomy. However, those results have been obtained mainly from a single institution, with only 4 patients treated in another center. Further research is still needed to evaluate its safety in a multi-center setting. The purpose of this study is to ensure the appropriate training of clinicians who will be performing this procedure and to capture long term outcomes and rare complications if any.
Conditions Studied
Interventions
- RADIATION Permanent Breast Seed Implant (PBSI)
Study Locations (3)
Pennsylvania
- Allegheny General Hospital - Pittsburgh
Virginia
- Mary Washington Hospital - Fredericksburg
Washington
- Swedish Cancer Institute - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2016-07 |
| Est. Completion | 2026-07 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02701244
The ClinicalTrials.gov registry entry for NCT02701244 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 565-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (26% lower). The listed sponsor is Concure Oncology-Breast Microseed, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Permanent Breast Seed Implant (PBSI) is the first listed.
NCT02701244 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Pennsylvania, Virginia, Washington.
Frequently Asked Questions
What is clinical trial NCT02701244 about?
NCT02701244 is a clinical study titled "A Registry Study of Breast Microseed Treatment". For women diagnosed with early stage breast cancer, lumpectomy followed by radiation is a common treatment option. Radiation treatment is typically delivered to the whole breast, five times per week, for anywhere from 3 to 8 weeks. The radiation helps kill any cancer cells that may have been left ov...
What is the current status of trial NCT02701244?
This trial is currently recruiting. The enrollment target is 420 participants. The study started on 2016-07. Estimated completion is 2026-07.
What conditions does trial NCT02701244 study?
This clinical trial studies the following conditions: Breast Neoplasms.
What interventions are being tested in trial NCT02701244?
The interventions under investigation include: Permanent Breast Seed Implant (PBSI) (RADIATION).
Who is sponsoring clinical trial NCT02701244?
This trial is sponsored by Concure Oncology-Breast Microseed, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02701244 being conducted?
This trial has 3 study locations across Pennsylvania, Virginia, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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