A Registry Study of Breast Microseed Treatment

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Concure Oncology-Breast Microseed Inc.
Study ID
NCT02701244
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Permanent Breast Seed Implant (PBSI) — RADIATION
    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).

Study Details

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.

Key Dates

Start date
Jul 31, 2016
Status verified
Mar 2018
Primary completion
Jul 31, 2021
Completion
Jul 31, 2026

Study Design

Enrollment
420 participants (estimated)

Arms

  • Arm: Permanent Breast Seed Implant (PBSI)
    Women with eligible early stage breast cancer who received a permanent breast seed implant status post lumpectomy

Primary Outcome Measure

Serious Adverse Events (SAE) [ Time Frame: Up to 10 years from procedure date ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Allegheny General HospitalPittsburghPennsylvania15212
Division of Radiation Oncology
412-359-3400
Mark Trombetta, MD (PRINCIPAL_INVESTIGATOR)
Mary Washington HospitalFredericksburgVirginia22401
John Chinault, MD (PRINCIPAL_INVESTIGATOR)
Swedish Cancer InstituteSeattleWashington98104
Robert Loomis
[email protected]
866-922-6237
Stephen Eulau, MD (PRINCIPAL_INVESTIGATOR)
Astrid D Morris, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Allegheny General Hospital· Pittsburgh, PAMary Washington Hospital· Fredericksburg, VASwedish Cancer Institute· Seattle, WA

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