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

• ClinicalTrials.gov Identifier: NCT01478438
• Recruitment Status: Unknown
• First Posted: November 23, 2011
• Last Update Posted: March 3, 2021
• Sponsor: Novian Health Inc.
• Information provided by (Responsible Party): Novian Health Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Malignant Tumor	Device: Novilase Interstitial Laser Therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers
• Study Start Date: April 2012
• Actual Primary Completion Date: December 2015
• Estimated Study Completion Date: August 2021

Arms and Interventions

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 Name: Novilase®

Outcome Measures

Primary Outcome Measures :

1. Collect information on the proportion of tumors ablated for sample size calculations in the pivotal trial [ Time Frame: one month end point ]

   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 :

1. To gain experience with the cosmetic outcome and rate of recovery tools [ Time Frame: One month end point ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes 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

Locations

United States, Arizona

The Breast Center of Southern Arizona

Tucson, Arizona, United States, 85712

United States, Colorado

Rose Medical Center - Rose Breast Center

Denver, Colorado, United States, 80220

United States, Illinois

St. Alexius Breast Care of St. Alexius Medical Center

Bartlett, Illinois, United States, 60103

Advocate Lutheran General Hospital - Caldwell Breast Center

Park Ridge, Illinois, United States, 60068

United States, Maryland

Walter Reed National Military Medical Center

Bethesda, Maryland, United States, 20889

United States, New York

Columbia University Medical Center - Department of Surgery

New York, New York, United States, 10032

United States, Ohio

University of Toledo - Eleanor N. Dana Cancer Center Breast Care

Toledo, Ohio, United States, 43614

United States, Oklahoma

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73126

United States, Wisconsin

Wheaton Franciscan Health System

Wauwatosa, Wisconsin, United States, 53226

United Kingdom

North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre

Bristol, United Kingdom, BS10 5NB

Mid Essex Hospital Services NHS Trust: Broomfield Hospital - Breast Unit

Chelmsford, United Kingdom, CM1 7ET

Norfolk & Norwich University NHS Foundation Trusts: Norfolk and Norwich University Hospital

Norwich, United Kingdom, NR4 7UY

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:

Related Info 

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.

• Responsible Party: Novian Health Inc.
• ClinicalTrials.gov Identifier: NCT01478438
• Other Study ID Numbers: BR-002
• First Posted: November 23, 2011
• Last Update Posted: March 3, 2021
• Last Verified: March 2021

Keywords provided by Novian Health Inc.:

Unifocal; 20mm in diameter; measures; 5mm away from the skin and chest

Additional relevant MeSH terms:

Neoplasms