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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malignant Tumor
• Intervention / Treatment: Device: Novilase Interstitial Laser Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre
  • Chelmsford, United Kingdom, CM1 7ET
    • Mid Essex Hospital Services NHS Trust: Broomfield Hospital - Breast Unit
  • Norwich, United Kingdom, NR4 7UY
    • Norfolk & Norwich University NHS Foundation Trusts: Norfolk and Norwich University Hospital
• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • The Breast Center of Southern Arizona
  • Colorado
    • Denver, Colorado, United States, 80220
      • Rose Medical Center - Rose Breast Center
  • Illinois
    • Bartlett, Illinois, United States, 60103
      • St. Alexius Breast Care of St. Alexius Medical Center
    • Park Ridge, Illinois, United States, 60068
      • Advocate Lutheran General Hospital - Caldwell Breast Center
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center - Department of Surgery
  • Ohio
    • Toledo, Ohio, United States, 43614
      • University of Toledo - Eleanor N. Dana Cancer Center Breast Care
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73126
      • University of Oklahoma Health Sciences Center
  • Wisconsin
    • Wauwatosa, Wisconsin, United States, 53226
      • Wheaton Franciscan Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Novilase®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ANTICIPATED): August 1, 2021

Study Registration Dates

• First Submitted: November 17, 2011
• First Submitted That Met QC Criteria: November 22, 2011
• First Posted (ESTIMATE): November 23, 2011

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Unifocal; 20mm in diameter; measures; 5mm away from the skin and chest
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: BR-002