Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant (PBSI)

January 29, 2026 updated by: Juanita Crook, British Columbia Cancer Agency
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • BCCA Center for the Southern Interior

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breast seed implant
Stranded palladium seed interstitial radioactive seed implant to seroma with margin with 3 dimensional ultrasound and CT guidance
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant quality
Time Frame: Day 0
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Investigators

  • Principal Investigator: Juanita Crook, MD, British Columbia Cancer Agency

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

February 1, 2021

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimated)

November 21, 2014

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H14-02175

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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