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

Malignant Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01478438
• Other study ID #: BR-002
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2012
• Est. completion date: August 2021

Study information

• Verified date: March 2021
• Source: Novian Health Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 2021
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignant Tumor
• Neoplasms

Intervention

Device:
• Novilase Interstitial Laser Therapy
Image guided Interstitial Laser Ablation of breast tumors

Locations

Country	Name	City	State
United Kingdom	North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre	Bristol
United Kingdom	Mid Essex Hospital Services NHS Trust: Broomfield Hospital - Breast Unit	Chelmsford
United Kingdom	Norfolk & Norwich University NHS Foundation Trusts: Norfolk and Norwich University Hospital	Norwich
United States	St. Alexius Breast Care of St. Alexius Medical Center	Bartlett	Illinois
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Rose Medical Center - Rose Breast Center	Denver	Colorado
United States	Columbia University Medical Center - Department of Surgery	New York	New York
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Advocate Lutheran General Hospital - Caldwell Breast Center	Park Ridge	Illinois
United States	University of Toledo - Eleanor N. Dana Cancer Center Breast Care	Toledo	Ohio
United States	The Breast Center of Southern Arizona	Tucson	Arizona
United States	Wheaton Franciscan Health System	Wauwatosa	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Novian Health Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

References & Publications (2)

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. — View Citation

Dowlatshahi K, Francescatti DS, Bloom KJ. Laser therapy for small breast cancers. Am J Surg. 2002 Oct;184(4):359-63. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

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