A Registry Study of Breast Microseed Treatment

Status unconfirmed

Conditions studied: Breast Neoplasms

In brief

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 facts

Study ID

NCT02701244

Run by

Concure Oncology-Breast Microseed Inc.

People needed

420

Starts

2016-07-01

Expected to finish

2026-07-01

Last updated by the study team

2018-03-19

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histological diagnosis of invasive or in-situ ductal carcinoma (DCIS)
• Treated by breast conserving surgery with axillary node dissection (with a minimum of 6 nodes sampled) or sentinel lymph node biopsy
• Surgical margins clear for invasive carcinoma (no tumor at ink margin) or superior or equal to 2 mm for in-situ ductal carcinoma (DCIS)
• A maximum tumor size of 3 cm
• Age ≥50 years old
• Informed consent signed if participating in the Registry

You may not qualify if…

• No previous cancer unless in remission for more than 2 years.
• Active auto immune disorder with severe vasculitis component
• Uncontrolled and complicated insulin-dependent diabetes
• Pregnancy
• Cosmetic breast implants
• Psychiatric or addictive disorder that would preclude attending follow-up
• Post-operative breast infection requiring prolonged antibiotic therapy
• Lobular features on histology (pure or mixed) or sarcoma histology
• Node macroscopically positive on axillary dissection or in the sentinel lymph node biopsy
• Extensive in- situ carcinoma
• Multicentric disease (in more than one quadrant or separated by 2 cm or more)
• Paget's disease of the nipple
• Metastases
• Patients presenting with a large post-surgical fluid cavity as determined on the planning Ultrasound (US), resistant to the application of hot compresses for 4 weeks
• Clear delineation of the target volume on Computerized Tomography (CT) is not possible
• Volume to be implanted over 150cc
• Target volume too close to skin such that the 90% isodose overlaps the skin surface

Where it is running

• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
• Mary Washington Hospital — Fredericksburg, Virginia, United States (enrolling)
• Swedish Cancer Institute — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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