A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers
NCT ID: NCT01478438
Last Updated: 2021-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2012-04-30
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treat and Excise
All subjects will be treated with Interstitial Laser Therapy (ILT) followed by excision no later than 28 days post ablation.
Novilase Interstitial Laser Therapy
Image guided Interstitial Laser Ablation of breast tumors
Interventions
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Novilase Interstitial Laser Therapy
Image guided Interstitial Laser Ablation of breast tumors
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tumor is well visualized through x-ray mammography or ultrasound imaging and amenable to image guidance therapy (a tumor which is well visualized through imaging can be identified from surrounding breast tissue and does not have margins
* obscured by other structures or artifacts on the images)
* Tumor must be well visualized (as defined above) on MRI
* Definitive pathologic diagnosis by needle core biopsy
* Unifocal malignant tumor that does not exceed 20mm in diameter and measures at least 5mm away from the skin and chest wall
* Cluster of microcalcifications that do not exceed 10 mm in diameter and measures at least 5mm away from the skin and chest wall
* Subjects with or without palpable lymph nodes
* Subjects with mammographic appearance of overall dense parenchymal tissue may be included, as long as a clearly evident marker is present at tumor site
* Subjects with less than 25% intraductal component
* Subject has no clinically significant co-morbidities (i.e. chronic illnesses existing simultaneously with and usually independent of breast cancer) that affect life expectancy. Subject has given written informed consent
* Subject agrees to comply with follow up visits
Exclusion Criteria
* Pregnant or breast-feeding women
* Tumors poorly visualized by x-ray mammography or ultrasound imaging
* Women who are morbidly obese (\>300 lbs)
* Acute or chronic severe renal insufficiency (Glomerular filtration rate (GFR) \<30ml/min/1.73 sq.meters)
* Moderate to end-stage kidney disease and a history of severe asthma or allergies
* Tumors measuring greater than 20mm in diameter
* Subjects with advanced stage breast cancer
* Subjects with prior history of cancer in the ILT treated breast
* Subjects with recurrent breast cancer
* Subjects with lobular neoplasm, metastatic carcinoma to breast, sarcoma, Phylloides tumor, or Paget's disease
* Subjects with benign vascular tumor
* Subjects with benign lesions such as fibroadenoma, atypical ductal hyperplasia, sclerosing adenosis, Papilloma, fibrocystic disease of breast
* Subjects with DCIS with microinvasion
* Subjects with a cluster of microcalcifications whose diameter is larger than 10 mm.
* Subjects with extensive intraductal component and other characteristics not well visualized by imaging studies
* Subjects who are BRCA positive.
* Inability to lie prone or supine for one hour
* Currently participating or enrolled in another investigational treatment, device or drug study through follow up
* Undergoing concurrent neoadjuvant therapies for breast cancer
* Cardiac pacemaker or other metallic implants which would prevent patient from safely undergoing MRI scan
18 Years
80 Years
FEMALE
No
Sponsors
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Novian Health Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Barbara Schwartzberg, MD
Role: PRINCIPAL_INVESTIGATOR
Rose Medical Center - Rose Breast Center
Michael Shere, M.D.
Role: PRINCIPAL_INVESTIGATOR
North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre
Locations
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The Breast Center of Southern Arizona
Tucson, Arizona, United States
Rose Medical Center - Rose Breast Center
Denver, Colorado, United States
St. Alexius Breast Care of St. Alexius Medical Center
Bartlett, Illinois, United States
Advocate Lutheran General Hospital - Caldwell Breast Center
Park Ridge, Illinois, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Columbia University Medical Center - Department of Surgery
New York, New York, United States
University of Toledo - Eleanor N. Dana Cancer Center Breast Care
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Wheaton Franciscan Health System
Wauwatosa, Wisconsin, United States
North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre
Bristol, , United Kingdom
Mid Essex Hospital Services NHS Trust: Broomfield Hospital - Breast Unit
Chelmsford, , United Kingdom
Norfolk & Norwich University NHS Foundation Trusts: Norfolk and Norwich University Hospital
Norwich, , United Kingdom
Countries
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References
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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.
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.
Related Links
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Related Info
Other Identifiers
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BR-002
Identifier Type: -
Identifier Source: org_study_id
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