Early Stage Breast CancerPBSINCT02297672
Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant
A study testing Stranded palladium seed interstitial implant, 3 dimensional breast ultrasound and Computerized tomography (CT) in people with Early Stage Breast Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 55 to 80 years, women only
- Conditions the study is for
- Early Stage Breast Cancer
- What is being tested?
- Stranded palladium seed interstitial implant, 3 dimensional breast ultrasound and Computerized tomography (CT)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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,
Trial locations and contacts
1 site in 1 country.
Canada1 site
BCCA Center for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
About this study
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.
Read the 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
- Being tested
- Stranded palladium seed interstitial implant, 3 dimensional breast ultrasound, Computerized tomography (CT)
- Keywords
- breast cancer, brachytherapy, partial breast radiotherapy, palladium 103
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stranded palladium seed interstitial implantRadiation
Interstitial implantation of stranded palladium 103 seeds in seroma with a margin
3 dimensional breast ultrasoundDevice
guidance of placement of interstitial needles in breast
Computerized tomography (CT)Device
Breast CT for planning and assessing interstitial implantation of radioactive seeds
| Study group | Role | What they receive |
|---|---|---|
| Breast seed implant | Experimental | Stranded palladium seed interstitial radioactive seed implant to seroma with margin with 3 dimensional ultrasound and CT guidance Receives: Radiation: Stranded palladium seed interstitial implant; Device: 3 dimensional breast ultrasound; Device: Computerized tomography (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 0
Secondary outcomes (7)
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
Measured: Day 0
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
Measured: Day 0
Cosmesis
Physician assessed using the questionnaire from the Radiation Therapy Oncology Group (RTOG) and National Surgical Adjuvant Breast Project (NSABP)
Measured: 5 years
Acute and Late Toxicity of breast brachytherapy
Physician assessed using the Common Terminology Criteria for Adverse Events (CTCAE V4) form
Measured: 5 years
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
Measured: 3 years
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)
Measured: Day 0
Cost
Cost to health care system (Canadian dollars) and patient (expenses and lost wages in Canadian dollars)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completionFeb 2021
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Early Stage Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juanita Crook, British Columbia Cancer Agency
- Investigators
- Juanita Crook, MD, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297672
- Sponsor's protocol ID
- H14-02175
- Acronym
- PBSI
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2014
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16182464Keller 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.
PubMed 22019237Olivotto 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.
PubMed 23835717
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant
- ClinicalTrials.gov ID
- NCT02297672
- Acronym / sponsor ID
- PBSI / H14-02175
- Conditions
- Early Stage Breast Cancer
- Keywords
- breast cancer, brachytherapy, partial breast radiotherapy, palladium 103
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- Feb 2026 (estimated)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast seed implant | Experimental | Radiation: Stranded palladium seed interstitial implant, Device: 3 dimensional breast ultrasound, Device: Computerized tomography (CT)Stranded palladium seed interstitial radioactive seed implant to seroma with margin with 3 dimensional ultrasound and CT guidance |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient consent and signature of approved consent form.
Key exclusion criteria (18 listed)
- Stage T2 or higher breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stranded palladium seed interstitial implantInterstitial implantation of stranded palladium 103 seeds in seroma with a margin | Radiation | Breast seed implant |
| 3 dimensional breast ultrasoundguidance of placement of interstitial needles in breast | Device | Breast seed implant |
| Computerized tomography (CT)Breast CT for planning and assessing interstitial implantation of radioactive seeds | Device | Breast seed implant |
Primary outcome
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).
7 secondary outcomes
Eligibility for implant based on seroma size and location within breast
Time frame: Day 0
Feasibility of 3D US for procedure guidance
Time frame: Day 0
Cosmesis
Time frame: 5 years
Acute and Late Toxicity of breast brachytherapy
Time frame: 5 years
Patient Assessed Quality of life using the NSABP/RTOG breast Cancer Quality of Life questionnaire
Time frame: 3 years
Dose to Organs at risk
Time frame: Day 0
Cost
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Results publication: PubMed 16182464Pignol 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.
- Results publication: PubMed 22019237Keller 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.
- Results publication: PubMed 23835717Olivotto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juanita Crook, MD principal investigator
British Columbia Cancer Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stranded palladium seed interstitial implant, 3 dimensional breast ultrasound and Computerized tomography (CT) in people with Early Stage Breast Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant quality (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02297672, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026; AzTrials last refreshed its copy on 1 Nov 2026.