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A Registry Study of Permanent Breast Seed Implant

NCT01106521 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2021-10-29

No results posted yet for this study

Summary

Women found to have early stage breast cancer will have their cancer surgically removed followed by radiation treatment to the entire breast, five times per week for several weeks. The radiation treatment prevents the cancer from growing back but creates skin burns. Several studies have showed that it is nor necessary treating the whole breast.

The investigators team has pioneered a new therapy realizing the permanent implantation of tiny radioactive seeds into the surgical cavity in a single one hour procedure under light anesthesia. Patients live a normal life while receiving the radiation treatment. The results of a first clinical trial on 67 patients shows that the treatment is well tolerate and efficient. The purpose of the study is to offer the treatment in several places and to increase the cohort of patient to 420 to capture rare complications if any.

Conditions

  • Breast Neoplasms

Interventions

RADIATION

Permanent breast seeds implant

Patients are pre-planned using CT simulation. Implant is realised under light sedation and local freezing. Stranded seeds are inserted using a brachytherapy template that is immobilised to the planned target volume using a 'localization' needle. Patients is released the same day and Quality Assurance involves a 2 months post-implant CT

Sponsors & Collaborators

  • West Penn Allegheny Health System

    collaborator OTHER

  • British Columbia Cancer Agency

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Eric Leung, MD · Sunnybrook Health Sciences Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2018-01-19
Completion
2018-01-19

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01106521 on ClinicalTrials.gov