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

Primary Purpose

Early Stage Breast Cancer

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Stranded palladium seed interstitial implant
3 dimensional breast ultrasound
Computerized tomography (CT)
Sponsored by
British Columbia Cancer Agency
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Stage Breast Cancer focused on measuring breast cancer, brachytherapy, partial breast radiotherapy, palladium 103

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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,

Sites / Locations

  • BCCA Center for the Southern Interior

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Breast seed implant

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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
Cosmesis
Physician assessed using the questionnaire from the Radiation Therapy Oncology Group (RTOG) and National Surgical Adjuvant Breast Project (NSABP)
Toxicity
Physician assessed using the Common Terminology Criteria for Adverse Events (CTCAE V4) form
Quality of life
Patient assessed using the RTOG/NSABP Breast Cancer Quality of Life Assessment form
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)
Cost
Cost to health care system (Canadian dollars) and patient (expenses and lost wages in Canadian dollars)

Full Information

First Posted
November 14, 2014
Last Updated
May 19, 2023
Sponsor
British Columbia Cancer Agency
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1. Study Identification

Unique Protocol Identification Number
NCT02297672
Brief Title
Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant
Acronym
PBSI
Official Title
Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2021 (Actual)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
British Columbia Cancer Agency

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Stage Breast Cancer
Keywords
breast cancer, brachytherapy, partial breast radiotherapy, palladium 103

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breast seed implant
Arm Type
Experimental
Arm Description
Stranded palladium seed interstitial radioactive seed implant to seroma with margin with 3 dimensional ultrasound and CT guidance
Intervention Type
Radiation
Intervention Name(s)
Stranded palladium seed interstitial implant
Intervention Description
Interstitial implantation of stranded palladium 103 seeds in seroma with a margin
Intervention Type
Device
Intervention Name(s)
3 dimensional breast ultrasound
Intervention Description
guidance of placement of interstitial needles in breast
Intervention Type
Device
Intervention Name(s)
Computerized tomography (CT)
Intervention Description
Breast CT for planning and assessing interstitial implantation of radioactive seeds
Primary Outcome Measure Information:
Title
Implant quality
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).
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Eligibility for implant based on seroma size and location within breast
Description
US and CT evaluation to record the range of seroma volumes and quadrant location in the breast acceptable for implantation
Time Frame
Day 0
Title
Feasibility of 3D US for procedure guidance
Description
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
Time Frame
Day 0
Title
Cosmesis
Description
Physician assessed using the questionnaire from the Radiation Therapy Oncology Group (RTOG) and National Surgical Adjuvant Breast Project (NSABP)
Time Frame
5 years
Title
Toxicity
Description
Physician assessed using the Common Terminology Criteria for Adverse Events (CTCAE V4) form
Time Frame
5 years
Title
Quality of life
Description
Patient assessed using the RTOG/NSABP Breast Cancer Quality of Life Assessment form
Time Frame
5 years
Title
Dose to Organs at risk
Description
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)
Time Frame
Day 0
Title
Cost
Description
Cost to health care system (Canadian dollars) and patient (expenses and lost wages in Canadian dollars)
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juanita Crook, MD
Organizational Affiliation
British Columbia Cancer Agency
Official's Role
Principal Investigator
Facility Information:
Facility Name
BCCA Center for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16182464
Citation
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.
Results Reference
result
PubMed Identifier
22019237
Citation
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.
Results Reference
result
PubMed Identifier
23835717
Citation
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.
Results Reference
result

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Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant

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