RECRUITING

A Registry Study of Breast Microseed Treatment

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2016-07
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02701244

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histological diagnosis of invasive or in-situ ductal carcinoma (DCIS)
  2. * Treated by breast conserving surgery with axillary node dissection (with a minimum of 6 nodes sampled) or sentinel lymph node biopsy
  3. * Surgical margins clear for invasive carcinoma (no tumor at ink margin) or superior or equal to 2 mm for in-situ ductal carcinoma (DCIS)
  4. * A maximum tumor size of 3 cm
  5. * Age ≥50 years old
  6. * Informed consent signed if participating in the Registry
  1. * No previous cancer unless in remission for more than 2 years.
  2. * Active auto immune disorder with severe vasculitis component
  3. * Uncontrolled and complicated insulin-dependent diabetes
  4. * Pregnancy
  5. * Cosmetic breast implants
  6. * Psychiatric or addictive disorder that would preclude attending follow-up
  7. * Post-operative breast infection requiring prolonged antibiotic therapy
  8. * Lobular features on histology (pure or mixed) or sarcoma histology
  9. * Node macroscopically positive on axillary dissection or in the sentinel lymph node biopsy
  10. * Extensive in- situ carcinoma
  11. * Multicentric disease (in more than one quadrant or separated by 2 cm or more)
  12. * Paget's disease of the nipple
  13. * Metastases
  14. * 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
  15. * Clear delineation of the target volume on Computerized Tomography (CT) is not possible
  16. * Volume to be implanted over 150cc
  17. * Target volume too close to skin such that the 90% isodose overlaps the skin surface

Contacts and Locations

Study Contact

Juanita Crook, MD
CONTACT
+1 250 712 3958
jcrook@bccancer.bc.ca
Jean-Philippe Pignol, MD, PhD
CONTACT
+31 10 704 13 66
j.p.pignol@erasmusmc.nl

Principal Investigator

Juanita Crook, MD
PRINCIPAL_INVESTIGATOR
British Columbia Cancer Agency
Jean-Philippe Pignol, MD, PhD
PRINCIPAL_INVESTIGATOR
Erasmus Medical Center

Study Locations (Sites)

Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
Mary Washington Hospital
Fredericksburg, Virginia, 22401
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: Concure Oncology-Breast Microseed Inc.

  • Juanita Crook, MD, PRINCIPAL_INVESTIGATOR, British Columbia Cancer Agency
  • Jean-Philippe Pignol, MD, PhD, PRINCIPAL_INVESTIGATOR, Erasmus Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-07
Study Completion Date2026-07

Study Record Updates

Study Start Date2016-07
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Breast Neoplasms