Clinical trial · Interventional
Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant
NCT02297672CI-TRIAL-00102217PBSIactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3 dimensional breast ultrasound | Device | — | UNRESOLVED |
| Computerized tomography (CT) | Device | — | UNRESOLVED |
| Stranded palladium seed interstitial implant | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast seed implant
- description
- Stranded palladium seed interstitial radioactive seed implant to seroma with margin with 3 dimensional ultrasound and CT guidance
- interventionNames
- Radiation: Stranded palladium seed interstitial implant
- Device: 3 dimensional breast ultrasound
- Device: Computerized tomography (CT)
Primary outcomes (1)
- measure
- Implant quality
- timeFrame
- Day 0
- description
- 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).
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 55 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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,
References
Publications (3)
- RESULTPignol 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
- RESULTKeller 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
- RESULTOlivotto 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