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This study will determine the rate of complete tumor ablation of small breast cancers (≤ 20mm) by Novilase Interstitial Laser Therapy (ILT), and determine the sensitivity and specificity of imaging (MRI, mammography and ultrasound) in detecting residual tumor post ILT ablation as correlated to histopathology from the post-ablation excision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treat and Excise | Experimental | All subjects will be treated with Interstitial Laser Therapy (ILT) followed by excision no later than 28 days post ablation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novilase Interstitial Laser Therapy | Device | Image guided Interstitial Laser Ablation of breast tumors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Collect information on the proportion of tumors ablated for sample size calculations in the pivotal trial | Evaluate the rate of complete tumor ablation by Novilase ILT of small breast cancers and characterize the correlation of imaging (MR, US, x-ray) in detecting residual post ablation with histopathology of the excised specimen. An individual patient will be considered to have a complete ablation if the pathology results post excision demonstrates that no visible gross residual tumor is present. | one month end point |
| Measure | Description | Time Frame |
|---|---|---|
| To gain experience with the cosmetic outcome and rate of recovery tools | Evaluate satisfaction, utilizing the European Organization for Research and Treatment of Cancer Breast Cancer Specific Quality of Life Questionnaire (EORTC QLQ-BR23) survey and cosmetic outcome utilizing the physician-reported Four-Point Scoring System of Breast Cosmesis. | One month end point |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Schwartzberg, MD | Rose Medical Center - Rose Breast Center | Principal Investigator |
| Michael Shere, M.D. | North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Breast Center of Southern Arizona | Tucson | Arizona | 85712 | United States | ||
| Rose Medical Center - Rose Breast Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12383903 | Background | Dowlatshahi K, Francescatti DS, Bloom KJ. Laser therapy for small breast cancers. Am J Surg. 2002 Oct;184(4):359-63. doi: 10.1016/s0002-9610(02)00942-x. | |
| 15125752 | Background | Dowlatshahi K, Dieschbourg JJ, Bloom KJ. Laser therapy of breast cancer with 3-year follow-up. Breast J. 2004 May-Jun;10(3):240-3. doi: 10.1111/j.1075-122X.2004.21436.x. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 2, 2023 | |
| Reset | Aug 28, 2023 | |
| Release | Aug 30, 2023 |
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| Denver |
| Colorado |
| 80220 |
| United States |
| St. Alexius Breast Care of St. Alexius Medical Center | Bartlett | Illinois | 60103 | United States |
| Advocate Lutheran General Hospital - Caldwell Breast Center | Park Ridge | Illinois | 60068 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
| Columbia University Medical Center - Department of Surgery | New York | New York | 10032 | United States |
| University of Toledo - Eleanor N. Dana Cancer Center Breast Care | Toledo | Ohio | 43614 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73126 | United States |
| Wheaton Franciscan Health System | Wauwatosa | Wisconsin | 53226 | United States |
| North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre | Bristol | BS10 5NB | United Kingdom |
| Mid Essex Hospital Services NHS Trust: Broomfield Hospital - Breast Unit | Chelmsford | CM1 7ET | United Kingdom |
| Norfolk & Norwich University NHS Foundation Trusts: Norfolk and Norwich University Hospital | Norwich | NR4 7UY | United Kingdom |
| Reset | Sep 22, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 2, 2023 | Aug 28, 2023 | |||
| Aug 30, 2023 | Sep 22, 2023 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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