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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02297672
Recruitment Status : Recruiting
First Posted : November 21, 2014
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Juanita Crook, British Columbia Cancer Agency

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.

Condition or disease Intervention/treatment Phase
Early Stage Breast Cancer Radiation: Stranded palladium seed interstitial implant Device: 3 dimensional breast ultrasound Device: Computerized tomography (CT) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant
Study Start Date : February 2015
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Palladium

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Cosmesis [ Time Frame: 5 years ]
    Physician assessed using the questionnaire from the Radiation Therapy Oncology Group (RTOG) and National Surgical Adjuvant Breast Project (NSABP)

  4. Toxicity [ Time Frame: 5 years ]
    Physician assessed using the Common Terminology Criteria for Adverse Events (CTCAE V4) form

  5. Quality of life [ Time Frame: 5 years ]
    Patient assessed using the RTOG/NSABP Breast Cancer Quality of Life Assessment form

  6. 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)

  7. Cost [ Time Frame: 5 years ]
    Cost to health care system (Canadian dollars) and patient (expenses and lost wages in Canadian dollars)



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297672


Contacts
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Contact: Juanita M Crook, MD 250 712 3958 jcrook@bccancer.bc.ca
Contact: Deidre Batchelar, PhD 250 712 5566 dbatchelar@bccancer.bc.ca

Locations
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Canada, British Columbia
BCCA Center for the Southern Interior Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Juanita Crook, MD    250 712 3979    jcrook@bccancer.bc.ca   
Contact: Rezwan Chowdhury, MD    250 712 3900    rchowdhury@bccancer.bc.ca   
Principal Investigator: Juanita Crook, MD         
Sub-Investigator: Ross Halperin, MD         
Sub-Investigator: Rezwan Chowdhury, MD         
Sub-Investigator: Matthew Schmid, MSc         
Sub-Investigator: Deidre Batchelar, PhD         
Sub-Investigator: Michelle Hilts, PhD         
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
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Principal Investigator: Juanita Crook, MD British Columbia Cancer Agency

Publications of Results:
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Responsible Party: Juanita Crook, Radiation oncologist, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT02297672    
Other Study ID Numbers: H14-02175
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Keywords provided by Juanita Crook, British Columbia Cancer Agency:
breast cancer
brachytherapy
partial breast radiotherapy
palladium 103
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases