A Registry Study of Breast Microseed Treatment
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|ClinicalTrials.gov Identifier: NCT02701244|
Recruitment Status : Recruiting
First Posted : March 8, 2016
Last Update Posted : March 19, 2018
For women diagnosed with early stage breast cancer, lumpectomy followed by radiation is a common treatment option. Radiation treatment is typically delivered to the whole breast, five times per week, for anywhere from 3 to 8 weeks. The radiation helps kill any cancer cells that may have been left over following the surgery but causes skin burns. Many studies have demonstrated that radiation to the whole breast is not necessary, that it can be delivered to a portion of the breast where the cancer is more likely to recur.
A technique called a Permanent Breast Seed Implant (PBSI) involving the implantation of radioactive seeds has been developed to deliver the radiation to a portion of the breast. The procedure is performed on an out-patient basis under local anesthesia and light sedation. Because the radioactive seeds are permanently implanted in the breast, the patient is able to live a normal life while the seeds deliver the prescribed radiation to the breast.
Previous studies on PBSI demonstrate that it is a safe and effective alternative form of radiation for appropriately selected patients after lumpectomy. However, those results have been obtained mainly from a single institution, with only 4 patients treated in another center. Further research is still needed to evaluate its safety in a multi-center setting. The purpose of this study is to ensure the appropriate training of clinicians who will be performing this procedure and to capture long term outcomes and rare complications if any.
|Condition or disease||Intervention/treatment|
|Breast Neoplasms||Radiation: Permanent Breast Seed Implant (PBSI)|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||420 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||A Multicenter Registry Study of Breast Microseed Treatment for Early Stage Breast Cancer|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2026|
Permanent Breast Seed Implant (PBSI)
Women with eligible early stage breast cancer who received a permanent breast seed implant status post lumpectomy
Radiation: Permanent Breast Seed Implant (PBSI)
Patients are pre-planned using Computerized Tomography (CT) simulation. Implant is performed after surgery under light sedation and local freezing (alternatively general anesthesia). Stranded seeds are inserted using a brachytherapy template that is immobilized to the planned target volume using a 'localization' needle. Patients are released the same day and Quality Assurance involves post-implant Computerized Tomography (CT).
Other Name: Breast Microseed Treatment
- Serious Adverse Events (SAE) [ Time Frame: Up to 10 years from procedure date ]Serious Adverse Events (SAE) is an unintended sign, symptom, or syndrome illness that occurs during the period of observation in the clinical study and that is life threatening or result in death. Serious Adverse Events (SAE) corresponds to grade 4 or 5 signs or symptoms from the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03 scale.
- Breast Cancer Recurrence [ Time Frame: Up to 10 years from procedure date ]
Ipsilateral in-breast or chest wall recurrence is defined as evidence of invasive or in situ breast cancer (except lobular carcinoma in-situ (LCIS)) in the ipsilateral breast. It is important to get a pathology confirmation of the recurrence.
In case of ipsilateral recurrence or second primary breast cancer, a copy of the clinic note summarizing the localization (same quadrant, other quadrant, not specified), the pathology, the work-up and treatment plan will be submitted to the Registry. Patients will be followed beyond the diagnosis for survival assessment.
- Permanent Breast Seed Implant (PBSI) Side Effects [ Time Frame: At 2 months from procedure date ]Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03 scale.
- Permanent Breast Seed Implant (PBSI) Side Effects [ Time Frame: Yearly up to 10 years from procedure date ]Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03 scale.
- Cosmetic Outcome [ Time Frame: Yearly up to 10 years from procedure date ]Cosmetic results will be self-evaluated at each follow-up visit by the patients using the Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire
- Survival (either free of cancer or with disease present) [ Time Frame: Up to 10 years from procedure date ]Patient survival, either free of cancer or with disease present will be recorded at follow-up appointments
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): NCT02701244
|Contact: Juanita Crook, MD||+1 250 712 email@example.com|
|Contact: Jean-Philippe Pignol, MD, PhD||+31 10 704 13 firstname.lastname@example.org|
|United States, Pennsylvania|
|Allegheny General Hospital||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15212|
|Contact: Division of Radiation Oncology 412-359-3400|
|Principal Investigator: Mark Trombetta, MD|
|United States, Virginia|
|Mary Washington Hospital||Recruiting|
|Fredericksburg, Virginia, United States, 22401|
|Principal Investigator: John Chinault, MD|
|United States, Washington|
|Swedish Cancer Institute||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: Robert Loomis 866-922-6237 Robert.Loomis@swedish.org|
|Principal Investigator: Stephen Eulau, MD|
|Principal Investigator: Astrid D Morris, MD, MS|
|Principal Investigator:||Juanita Crook, MD||British Columbia Cancer Agency|
|Principal Investigator:||Jean-Philippe Pignol, MD, PhD||Erasmus Medical Center|