Recruiting

Breast Microseed

Sponsor:

Concure Oncology-Breast Microseed Inc.

Code:

NCT02701244

Conditions

Breast Neoplasms

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Permanent Breast Seed Implant (PBSI)

Study Details

Brief 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

Breast Neoplasms

Study ID

NCT02701244

Start date

Jul, 2016

Status verified date

Mar, 2018

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

420 participants

Anticipated

Interventions and Outcome Measures

Arms

Permanent Breast Seed Implant (PBSI)

Women with eligible early stage breast cancer who received a permanent breast seed implant status post lumpectomy

Interventions

Permanent 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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Division of Radiation Oncology

412-359-3400

Principal Investigator:

Mark Trombetta, MD

Mary Washington Hospital

Recruiting

Fredericksburg, Virginia, United States, 22401

Principal Investigator:

John Chinault, MD

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

Contacts

Principal Investigator:

Stephen Eulau, MD

More Information

Sponsor

Concure Oncology-Breast Microseed Inc.

Last update posted

Mar 19, 2018

Last verified

Mar, 2018

Keywords

  • Infiltrating Ductal Carcinoma
  • Ductal Carcinoma In Situ
  • Brachytherapy
  • Breast Neoplasms
  • Breast Diseases
  • Neoplasms
  • Neoplasms by Site

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Concure Oncology-Breast Microseed Inc. on 2018-03-19.