NCT02297672

Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: British Columbia Cancer Agency · Academic / Other
• Sex: Female
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Permanent Breast Seed Implant (PBSI) has been demonstrated to be a well accepted and well tolerated form of partial breast radiotherapy. This protocol aims to build on the initial experience and to further refine the technique and collect toxicity and cost data, especially in comparison to alternate forms of breast radiotherapy.

Detailed description

25 women with low stage (pT1pN0) breast cancer, grade 1 or 2, will be accrued for adjuvant partial breast radiotherapy using PBSI and prospectively followed for 5 years. The primary aims is to evaluate implant quality according to recognized dosimetric parameters. Secondary aims include elaboration of approaches to different technical scenarios imposed by variation in seroma size, shape and location within the breast (expanding the technical manual to include recommended approaches to implants in different sectors of the breast and in different size breasts), incorporation of the use of live 3D ultrasound in the procedure (as opposed to current use of 2D US), assessment of patient acceptance and quality of life, physician assessment of cosmesis, assessment of toxicity, and recording of cost to the patient and health care system compared to alternate forms of breast radiotherapy.

Conditions

• Early Stage Breast Cancer

Interventions

Type	Name	Description
RADIATION	Stranded palladium seed interstitial implant	Interstitial implantation of stranded palladium 103 seeds in seroma with a margin
DEVICE	3 dimensional breast ultrasound	guidance of placement of interstitial needles in breast
DEVICE	Computerized tomography (CT)	Breast CT for planning and assessing interstitial implantation of radioactive seeds

Timeline

• Start date: 2015-02-01
• Primary completion: 2021-02-01
• Completion: 2026-02-01
• First posted: 2014-11-21
• Last updated: 2026-02-02

Locations

1 site across 1 country: Canada