Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant

NCT02297672 | Active Not Recruiting DMC

• 1 other identifier: H14-02175
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Stage Breast Cancer

Keywords

breast cancer; brachytherapy; partial breast radiotherapy; palladium 103

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Eligibility for implant based on seroma size and location within breast

  Day 0

• Feasibility of 3D US for procedure guidance

  Day 0

• Cosmesis

  5 years

• Acute and Late Toxicity of breast brachytherapy

  5 years

• Patient Assessed Quality of life using the NSABP/RTOG breast Cancer Quality of Life questionnaire

  3 years

Study Arms (1)

Breast seed implant

EXPERIMENTAL

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

Radiation: Stranded palladium seed interstitial implant; Device: 3 dimensional breast ultrasound; Device: Computerized tomography (CT)

Interventions

Stranded palladium seed interstitial implant RADIATION

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

Breast seed implant

3 dimensional breast ultrasound DEVICE

guidance of placement of interstitial needles in breast

Breast seed implant

Computerized tomography (CT) DEVICE

Breast CT for planning and assessing interstitial implantation of radioactive seeds

Breast seed implant

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BCCA Center for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Related Publications (3)

• 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.

  PMID: 16182464 RESULT

• 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.

  PMID: 22019237 RESULT

• 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.

  PMID: 23835717 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Juanita Crook, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation oncologist

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 21, 2014
• Study Start: February 1, 2015
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

CA (1)