RecruitingNCT02701244

A Registry Study of Breast Microseed Treatment

A Multicenter Registry Study of Breast Microseed Treatment for Early Stage Breast Cancer


Sponsor

Concure Oncology-Breast Microseed Inc.

Enrollment

420 participants

Start Date

Jul 1, 2016

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking the long-term outcomes of breast cancer patients who are treated with a technique called breast microseed implantation — where tiny radioactive seeds are permanently placed inside the breast tissue after a lumpectomy (breast-conserving surgery) to deliver targeted internal radiation — to evaluate how well this approach controls cancer and what its effects on quality of life are over time. **You may be eligible if...** - You have been diagnosed with early-stage breast cancer - You are having or have had breast-conserving surgery (lumpectomy) at a participating center - Your treatment plan includes permanent radioactive microseed implantation as your radiation therapy - You are willing to attend follow-up appointments and participate in long-term data collection **You may NOT be eligible if...** - You have advanced or metastatic (widely spread) breast cancer - You have already received external radiation therapy to the same breast - You are pregnant or planning to become pregnant during the study period - You are not having the microseed implantation procedure as part of your treatment - You are unwilling or unable to attend follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONPermanent Breast Seed Implant (PBSI)

Patients are pre-planned using Computerized Tomography (CT) simulation. Implant is performed after surgery under light sedation and local freezing (alternatively general anesthesia). Stranded seeds are inserted using a brachytherapy template that is immobilized to the planned target volume using a 'localization' needle. Patients are released the same day and Quality Assurance involves post-implant Computerized Tomography (CT).


Locations(3)

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Mary Washington Hospital

Fredericksburg, Virginia, United States

Swedish Cancer Institute

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT02701244


Related Trials