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The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System for the delivery of radiation therapy as part of breast conserving therapy in women with resected, early stage breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | This is a single arm study where all patients are treated with FDA cleared electronic brachytherapy treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic brachytherapy (Axxent System) | Radiation | 3.4 Gy per fraction for 10 fractions for a total of 34 Gy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Delivery of 34 Gy in 10 Fractions | Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue) | measured at end of 10th fraction, usually within 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up. | Serious adverse device related events reported from treatment through 6 month follow-up and at 5-year follow-up are reported. | Through 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivek K Mehta, MD | Swedish Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mills Peninsula Hospital | San Mateo | California | 94401 | United States | ||
| Wellstar-Kennestone Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20375833 | Result | Mehta VK, Algan O, Griem KL, Dickler A, Haile K, Wazer DE, Stevens RE, Chadha M, Kurtzman S, Modin SD, Dowlatshahi K, Elliott KW, Rusch TW. Experience with an electronic brachytherapy technique for intracavitary accelerated partial breast irradiation. Am J Clin Oncol. 2010 Aug;33(4):327-35. doi: 10.1097/COC.0b013e3181d79d9e. |
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This was a single arm study, no randomization. Some patients consented but fell out of the study due to not meeting all eligibility (I/E) criteria after consenting to participation. 61 patients provided consent, 44 were treated.
Hospitals with radiation oncology departments who had acquired the Xoft Axxent system and were qualified to be in the study were chosen as the 10 sites. Breast surgeons and radiation oncologists were the site investigators at 10 sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Electronic Brachytherapy | Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eligibility Through 6 Month Follow-up |
|
| ||||||||||||||||||
| One-year Follow-up |
| |||||||||||||||||||
| 5 Year Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Electronic Brachytherapy | Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Delivery of 34 Gy in 10 Fractions | Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue) | All patients treated were analyzed | Posted | Number | Participants | measured at end of 10th fraction, usually within 7 days |
|
Treatment through 5 Year Follow-up.
Common Terminology Criteria V3 was used to report Adverse Events in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Electronic Brachytherapy | Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | CTCv3 Grades 2 and 3 | Systematic Assessment | Erythema grade 2 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael A. Patz MBA, RAC, Senior Director Clinical Affairs | iCAD, Inc. Xoft, Inc | 603-882-5200 | 7308 | mpatz@icadmed.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Marietta |
| Georgia |
| 30060 |
| United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Little Company of Mary Hospital | Evergreen Park | Illinois | 60805 | United States |
| Holy Cross Medical Center | Silver Spring | Maryland | 20910 | United States |
| Beth Israel Medical Center | New York | New York | 10003 | United States |
| Dickstein Cancer Center- White Plains Hospital | White Plains | New York | 10601 | United States |
| Oklahoma University Health Science Center | Oklahoma City | Oklahoma | 73104 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
|
|
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up. | Serious adverse device related events reported from treatment through 6 month follow-up and at 5-year follow-up are reported. | All patients treated were analyzed at 6 months except for 1 patient who was lost to follow-up. | Posted | Number | events | Through 6 months |
|
|
|
| 0 |
| 44 |
| 22 |
| 44 |
|
| Pain | Reproductive system and breast disorders | CTCv3 Grades 2 and 3 | Systematic Assessment | Pain CTC grade 2 |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCv3 Grades 2 and 3 | Systematic Assessment | Hyperpigmentation grade 2 |
|
| Moist desquamation | Skin and subcutaneous tissue disorders | CTCv3 Grades 2 and 3 | Systematic Assessment | Moist desquamation grade 3 |
|
| Infection | Infections and infestations | Other - not graded | Systematic Assessment |
|
| Seroma | Skin and subcutaneous tissue disorders | Other - not graded | Systematic Assessment |
|
The results are published; therefore the disclosure agreement is no longer in effect. The site investigators were to ask permission to publish single center results if they chose to publish prior to the entire study results were published.