Clinical trial NCT01478438: A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers
Official title: A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Tumor
Keywords: Unifocal
20mm in diameter
measures
5mm away from the skin and chest
Lead sponsor: Novian Health Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Females 18 to 80 years of age
* 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:

* Subjects younger than 18 years of age
* 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

Primary outcomes:
measure: Collect information on the proportion of tumors ablated for sample size calculations in the pivotal trial
timeFrame: one month end point
Secondary outcomes:
measure: To gain experience with the cosmetic outcome and rate of recovery tools
timeFrame: One month end point
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The Breast Center of Southern Arizona
state: Arizona
city: Denver
country: United States
facility: Rose Medical Center - Rose Breast Center
state: Colorado
city: Bartlett
country: United States
facility: St. Alexius Breast Care of St. Alexius Medical Center
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital - Caldwell Breast Center
state: Illinois
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: New York
country: United States
facility: Columbia University Medical Center - Department of Surgery
state: New York
city: Toledo
country: United States
facility: University of Toledo - Eleanor N. Dana Cancer Center Breast Care
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Wauwatosa
country: United States
facility: Wheaton Franciscan Health System
state: Wisconsin
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre
city: Chelmsford
country: United Kingdom
facility: Mid Essex Hospital Services NHS Trust: Broomfield Hospital - Breast Unit
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University NHS Foundation Trusts: Norfolk and Norwich University Hospital
Study officials:
affiliation: Rose Medical Center - Rose Breast Center
name: Barbara Schwartzberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre
name: Michael Shere, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.