Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant

NCT ID: NCT02297672

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2026-02-28

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Breast seed implant

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

Group Type: EXPERIMENTAL

Stranded palladium seed interstitial implant

Intervention Type: RADIATION

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

3 dimensional breast ultrasound

Intervention Type: DEVICE

guidance of placement of interstitial needles in breast

Computerized tomography (CT)

Intervention Type: DEVICE

Breast CT for planning and assessing interstitial implantation of radioactive seeds

Interventions

Stranded palladium seed interstitial implant

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

Intervention Type: RADIATION

3 dimensional breast ultrasound

guidance of placement of interstitial needles in breast

Intervention Type: DEVICE

Computerized tomography (CT)

Breast CT for planning and assessing interstitial implantation of radioactive seeds

Intervention Type: DEVICE

Eligibility Criteria

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,

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

British Columbia Cancer Agency

OTHER

Sponsor Role: lead

Responsible Party

Juanita Crook

Radiation oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juanita Crook, MD

Role: PRINCIPAL_INVESTIGATOR

British Columbia Cancer Agency

Locations

BCCA Center for the Southern Interior

Kelowna, British Columbia, Canada

Countries

Canada

References

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.ijrobp.2005.06.031. Epub 2005 Sep 22.

Reference Type: RESULT

PMID: 16182464 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22019237 (View on PubMed)

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 trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. J Clin Oncol. 2013 Nov 10;31(32):4038-45. doi: 10.1200/JCO.2013.50.5511. Epub 2013 Jul 8.

Reference Type: RESULT

PMID: 23835717 (View on PubMed)

Other Identifiers

H14-02175

Identifier Type: -

Identifier Source: org_study_id