Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant

Early Stage Breast Cancer Clinical Trial

— PBSI  

Official title:

Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02297672
• Other study ID #: H14-02175
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2015
• Est. completion date: February 2026

Study information

• Verified date: April 2024
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: February 2026
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient consent and signature of approved consent form.

• Age greater than 55 years and postmenopausal.

• Life expectancy of at least ten years

• Stage 0 or I breast cancer. Tumour size < 2 cm.

• Invasive cancer must be pathologic grade 1 or 2

• Histology must be either Ductal Carcinoma In Situ or invasive ductal adenocarcinoma of the breast.

• Tumour removed by lumpectomy with clear margins (DCIS and invasive).

• Unifocal disease

• For invasive breast cancer, axillary staging by either sentinel node biopsy or axillary dissection (minimum of 6 axillary nodes). Not required for DCIS.

• Brachytherapy generally should be performed within 16 weeks of the last surgery (lumpectomy, re-excision of margins, or axillary staging procedure). If > 16 weeks, will be assessed on case-by-case basis, based on seroma visibility and the presence of surgical clips in the tumour bed.

• Tumour must be Estrogen Receptor positive.

• The lumpectomy cavity (seroma) must be clearly delineated by ultrasound and CT and should be < 3 cm diameter (equivalent sphere) resulting in a maximum of 125 cc planning target volume (PTV).

• Breast seed implant must be considered technically deliverable by interstitial brachytherapy by the attending radiation oncologist and must be a minimum 2-plane implant.

• If prior non-breast malignancies, must have been disease-free for 5 or more years. Time limit waived for carcinoma in-situ of the cervix or colon, melanoma in-situ, and basal or squamous cell carcinoma of the skin.

Exclusion Criteria:

• Stage T2 or higher breast cancer

• Histologically positive axillary nodes.

• High grade (grade 3) invasive ductal carcinoma

• Extensive DCIS

• Lymphatic or Vascular Invasion positive

• Significant persistent post surgical complications

• Palpable or radiographically suspicious ipsilateral or contralateral axillary, or regional nodes, unless histologically confirmed negative.

• Suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast unless confirmed benign.

• Proven multi-centric carcinoma (invasive cancer or DCIS)

• Paget's disease of the nipple.

• Synchronous bilateral invasive or non-invasive breast cancer.

• History of previous ipsilateral invasive breast cancer or DCIS.

• Surgical margins that are positive or cannot be microscopically assessed.

• Clear delineation of the target lumpectomy cavity not possible.

• Breast implants.

• Prior ipsilateral breast or thoracic radiotherapy.

• Known genetic mutation in Breast Cancer Associated (BRCA 1 or 2)

• Collagen vascular disease,

Related Conditions & MeSH terms

• Breast Neoplasms
• Early Stage Breast Cancer

Intervention

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
• Computerized tomography (CT)
Breast CT for planning and assessing interstitial implantation of radioactive seeds

Locations

Country	Name	City	State
Canada	BCCA Center for the Southern Interior	Kelowna	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
British Columbia Cancer Agency

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Keller BM, Ravi A, Sankreacha R, Pignol JP. Permanent breast seed implant dosimetry quality assurance. Int J Radiat Oncol Biol Phys. 2012 May 1;83(1):84-92. doi: 10.1016/j.ijrobp.2011.05.030. Epub 2011 Oct 20. — View Citation

Olivotto IA, Whelan TJ, Parpia S, Kim DH, Berrang T, Truong PT, Kong I, Cochrane B, Nichol A, Roy I, Germain I, Akra M, Reed M, Fyles A, Trotter T, Perera F, Beckham W, Levine MN, Julian JA. Interim cosmetic and toxicity results from RAPID: a randomized t — View Citation

Pignol JP, Keller B, Rakovitch E, Sankreacha R, Easton H, Que W. First report of a permanent breast 103Pd seed implant as adjuvant radiation treatment for early-stage breast cancer. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):176-81. doi: 10.1016/j.ijr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant quality	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).	Day 0
Secondary	Eligibility for implant based on seroma size and location within breast	US and CT evaluation to record the range of seroma volumes and quadrant location in the breast acceptable for implantation	Day 0
Secondary	Feasibility of 3D US for procedure guidance	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	Day 0
Secondary	Cosmesis	Physician assessed using the questionnaire from the Radiation Therapy Oncology Group (RTOG) and National Surgical Adjuvant Breast Project (NSABP)	5 years
Secondary	Acute and Late Toxicity of breast brachytherapy	Physician assessed using the Common Terminology Criteria for Adverse Events (CTCAE V4) form	5 years
Secondary	Patient Assessed Quality of life using the NSABP/RTOG breast Cancer Quality of Life questionnaire	Patient assessed using the RTOG/NSABP Breast Cancer Quality of Life Assessment form	5 years
Secondary	Dose to Organs at risk	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)	Day 0
Secondary	Cost	Cost to health care system (Canadian dollars) and patient (expenses and lost wages in Canadian dollars)	5 years