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 January 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: January 21, 2014
Last verified: January 2014

November 17, 2011
January 21, 2014
April 2012
April 2014   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01478438 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers
A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Malignant Tumor
Device: Novilase Interstitial Laser Therapy
Image guided Interstitial Laser Ablation of breast tumors
Other Name: Novilase®
Experimental: Treat and Excise
All subjects will be treated with Interstitial Laser Therapy (ILT) followed by excision no later than 28 days post ablation.
Intervention: Device: Novilase Interstitial Laser Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
April 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 80 Years
No
Contact: Eugene Bajorinas 312-266-7200 ext 108 info@novianhealth.com
Contact: Marti DeLay 312-266-7200 ext 110 info@novianhealth.com
United States,   United Kingdom
 
NCT01478438
BR-002
Not Provided
Novian Health Inc.
Novian Health Inc.
Not Provided
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
Novian Health Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP