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A Prospective Study to Evaluate the Feasibility of Partial Breast Irradiation Utilizing Permanent Breast Seed Implant in British Columbia

60 Years
Not Enrolling
Breast Cancer

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Trial Information

A Prospective Study to Evaluate the Feasibility of Partial Breast Irradiation Utilizing Permanent Breast Seed Implant in British Columbia

Inclusion Criteria:

1. Female subject with a pathologically-confirmed diagnosis of invasive ductal

2. Tumor size < 2cm.

3. Negative axillary node involvement, determined by either

1. Sentinel node biopsy,

2. Axillary node dissection removing > 6 nodes

4. No evidence of metastatic disease.

5. Treated by BCS with microscopically clear resection margins (> 2mm to ink) for
invasive and non-invasive disease or no residual disease on re-excision.

Exclusion Criteria:

1. Age < 60 years.

2. Subjects who will receive adjuvant chemotherapy.

3. A known deleterious mutation in BRCA-1 and/or BRCA-2.

4. Extensive DCIS, mammographically or pathologically.

5. Tumor histology of pure lobular carcinoma (invasive or in-situ).

6. Adenoid cystic and non-epithelial malignancies (e.g. sarcoma or lymphoma).

7. Lymphovascular invasion (LVI) present.

8. Bilateral invasive malignancy of the breast (synchronous or metachronous).

9. More than one ipsilateral breast primary tumor.

10. Previous irradiation to the ipsilateral breast.

11. Presence of an ipsilateral breast implant.

12. Serious non-malignant disease that precludes radiation treatment or conscious

13. Unable for any reason to undergo PBSI within 14 weeks of the last breast surgery.

14. Concomitant malignancies, except non-melanoma skin cancer and carcinoma in situ of
any site.

15. Significant persistent post-surgical complications.

16. Currently pregnant or lactating.

17. Psychiatric or addictive disorders which would preclude obtaining informed consent.

18. Subject not committed to at least 3 years of follow-up.

19. Low CBC levels: HB < 100 - Platelets < 100 - Neutrophil count < 1

20. Close partner not consenting

21. Inability to confidently localize/delineate the surgical cavity on CT and/or US.

22. Subject not suitable for a minimum 2-plane implant based on tumor location/breast

23. Seroma exceeding 3cm

24. Seroma within the inner quadrants

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Technical parameters of the implant

Outcome Description:

Implant technical parameters will include: SC (Surgical Cavity/Seroma) volume (average & range) PTV (average & range) Number of seeds per implant (average & range) Average total seed activity per implant From DVH, average and range of: V90 V100 V150 V200 DHI Number of seeds at a distance 5 mm or less from the skin surface Absolute (cc) and proportional (%) volume of ipsilateral breast receiving 90%, 50% and 10 % of the prescribed dose

Outcome Time Frame:

Measured once for each subject at a post-implant CT on the same day as the implant procedure. Will be assessed collectively once treatment is completed for all 5 subjects.

Safety Issue:


Principal Investigator

Hosam A Kader, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

BCCA, Department of Radiation Oncology


Canada: Health Canada

Study ID:




Start Date:

September 2011

Completion Date:

September 2016

Related Keywords:

  • Breast Cancer
  • Brachytherapy, Partial Breast Irradiation, Breast Seed Implant, Palladium Seeds
  • Breast Neoplasms