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Breast Diseases

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Stranded palladium seed interstitial radioactive seed implant to seroma with margin with 3 dimensional ultrasound and CT guidance

Interstitial implantation of stranded palladium 103 seeds in seroma with a margin

Stranded palladium seed interstitial implant

guidance of placement of interstitial needles in breast

3 dimensional breast ultrasound

Breast CT for planning and assessing interstitial implantation of radioactive seeds

Computerized tomography (CT)

Juanita Crook, MD

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.

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.

Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant

Post implant CT evaluation to report dosimetric parameters including the minimum dose in Gray to 90% of the target volume (D90) and the percentage of the target volume (seroma, seroma with 5 mm margin, seroma with 10 mm margin) receiving 100% of the prescribed dose (V100).

US and CT evaluation to record the range of seroma volumes and quadrant location in the breast acceptable for implantation

Post implant CT evaluation describing dosimetric parameters (D90 and V100 as above in Outcome 1) with the use of 3D ultrasound and with 2D ultrasound

Physician assessed using the questionnaire from the Radiation Therapy Oncology Group (RTOG) and National Surgical Adjuvant Breast Project (NSABP)

Physician assessed using the Common Terminology Criteria for Adverse Events (CTCAE V4) form

Patient assessed using the RTOG/NSABP Breast Cancer Quality of Life Assessment form

Post implant CT assessment describing calculated doses to lung, ribs and heart described as the highest dose to 1 cc of the specific organ tissue and skin dose recorded as an area 1 cm by 1 cm by 2 mm thick (1cmx1cmx0.2cm)

Cost to health care system (Canadian dollars) and patient (expenses and lost wages in Canadian dollars)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant	NCT02297672	Early Stage Bre...	Stranded pallad... 3 dimensional b... Computerized to...	55 Years - 80 Years	British Columbia Cancer Agency
Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant	NCT02297672	Early Stage Bre...	Stranded pallad... 3 dimensional b... Computerized to...	55 Years - 80 Years	British Columbia Cancer Agency

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