A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Novian Health Inc.
Sponsor:
Information provided by (Responsible Party):
Novian Health Inc.
ClinicalTrials.gov Identifier:
NCT01478438
First received: November 17, 2011
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Malignant Tumor
Device: Novilase Interstitial Laser Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers

Resource links provided by NLM:


Further study details as provided by Novian Health Inc.:

Primary Outcome Measures:
  • Collect information on the proportion of tumors ablated for sample size calculations in the pivotal trial [ Time Frame: one month end point ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • To gain experience with the cosmetic outcome and rate of recovery tools [ Time Frame: One month end point ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treat and Excise
All subjects will be treated with Interstitial Laser Therapy (ILT) followed by excision no later than 28 days post ablation.
Device: Novilase Interstitial Laser Therapy
Image guided Interstitial Laser Ablation of breast tumors
Other Name: Novilase®

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478438

Contacts
Contact: Eugene Bajorinas 312-266-7200 ext 108 info@novianhealth.com
Contact: Marti DeLay 312-266-7200 ext 110 info@novianhealth.com

Locations
United States, Arizona
The Breast Center of Southern Arizona Recruiting
Tucson, Arizona, United States, 85712
Contact: Eric Whitacre    520-319-6686      
Principal Investigator: Eric Whitacre, M.D.         
United States, Colorado
Rose Medical Center - Rose Breast Center Recruiting
Denver, Colorado, United States, 80220
Contact: Barbara Schwartzberg, M.D.    303-320-7127      
Principal Investigator: Barbara Schwartzberg, M.D.         
United States, Illinois
St. Alexius Breast Care of St. Alexius Medical Center Recruiting
Bartlett, Illinois, United States, 60103
Contact: Robert Maganini, M.D.    847-755-8700      
Principal Investigator: Robert Maganini, M.D.         
Advocate Lutheran General Hospital - Caldwell Breast Center Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Heidi Memmel, M.D.    847-723-3100      
Principal Investigator: Heidi Memmel, M.D.         
United States, Maryland
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889
Contact: Craig Shriver, M.D.    301-295-3899      
Principal Investigator: COL Craig Shriver, M.D.         
Sub-Investigator: CDR Jacqueline Bernard, M.D.         
Sub-Investigator: Pria Bhandarkar, M.D.         
Sub-Investigator: Cheryl Troy, M.D.         
United States, New York
Columbia University Medical Center - Department of Surgery Recruiting
New York City, New York, United States, 10032
Contact: Margaret Chen    212-305-9676      
Principal Investigator: Margaret Chen, M.D.         
Sub-Investigator: Sheldon Feldman, M.D.         
Sub-Investigator: Bret Taback, M.D.         
Sub-Investigator: Preya Ananthakrishnan, M.D.         
United States, Ohio
University of Toledo - Eleanor N. Dana Cancer Center Breast Care Recruiting
Toledo, Ohio, United States, 43614
Contact: Helen Mabry, M.D.    419-383-4000      
Principal Investigator: Helen Mabry, M.D.         
Sub-Investigator: Prabir K. Chaudhuri, M.D.         
United States, Oklahoma
University of Oklahoma Health Sciences Center Active, not recruiting
Oklahoma City, Oklahoma, United States, 73126
United States, Wisconsin
Wheaton Franciscan Health System Recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Hanadi Bu-Ali, M.D.    414-256-1920      
Contact: Jodi Brehm, M.D.    414-256-1920      
Principal Investigator: Hanadi Bu-Ali, M.D.         
Sub-Investigator: Jodi Brehm, M.D.         
United Kingdom
North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre Recruiting
Bristol, United Kingdom, BS10 5NB
Contact: Michael Shere, M.D.    0117 3237000      
Principal Investigator: Michael Shere, M.D.         
Sub-Investigator: Lyn Jones, M.D.         
Mid Essex Hospital Services NHS Trust: Broomfield Hospital - Breast Unit Recruiting
Chelmsford, United Kingdom, CM1 7ET
Contact: Simon Smith, M.D.    01245 513343      
Principal Investigator: Simon Smith         
Sub-Investigator: Roger Whitney, M.D.         
Norfolk & Norwich University NHS Foundation Trusts: Norfolk and Norwich University Hospital Recruiting
Norwich, United Kingdom, NR4 7UY
Contact: Arne Juette, M.D.    01603 288893      
Principal Investigator: Arne Juette, M.D.         
Sub-Investigator: Simon Pain, M.D.         
Sponsors and Collaborators
Novian Health Inc.
Investigators
Principal Investigator: 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
  More Information

Additional Information:
Publications:
Responsible Party: Novian Health Inc.
ClinicalTrials.gov Identifier: NCT01478438     History of Changes
Other Study ID Numbers: BR-002
Study First Received: November 17, 2011
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novian Health Inc.:
Unifocal
20mm in diameter
measures
5mm away from the skin and chest

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 21, 2014