Actively Recruiting
Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors
Led by Novian Health Inc. · Updated on 2026-02-19
122
Participants Needed
13
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prior to this confirmatory pivotal study, the multicenter Br-002 feasibility study was completed. 98% of tumors less than or equal to 15mm were completely ablated in one procedure.This study will evaluate Novilase for the focal destruction of malignant tumors of the breast that are less than or equal to 15 mm against a performance goal for the standard of care, lumpectomy. The ASBrS' goal of less than 20% retreatment by 2020 was selected as a representative performance goal, i.e., 80.0%, and is consistent with published effectiveness rates for lumpectomy.
CONDITIONS
Official Title
Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Able to provide written informed consent
- Definitive malignant tumor diagnosis by needle core biopsy
- Single malignant breast tumor (T1a-c, N0-1, M0) measuring 15 mm or less in longest dimension
- Tumor at least 5 mm away from skin and chest wall or movable 5 mm away by saline or anesthetic injection
- Calcifications confined to tumor no larger than 10 mm
- Tumor clearly visible on ultrasound or x-ray mammography and suitable for image-guided therapy
- Tumor clearly visible on MRI
- Dense breast tissue allowed if tumor site marker is clear
- Intraductal component less than 25% by core biopsy
- No significant co-morbid conditions affecting life expectancy
- Weight of 300 lbs (136 kg) or less
- Agree to follow prescribed radiation or adjuvant therapy
You will not qualify if you...
- Younger than 18 years
- Pregnant or breastfeeding
- Tumor poorly seen on ultrasound or x-ray mammography
- Contraindication to gadolinium contrast (allergy, kidney disease, severe renal insufficiency with GFR <30 ml/min/1.73 m2)
- Contraindication to MRI (e.g., pacemaker, metallic implants)
- History of severe asthma
- Tumor larger than 15 mm
- Microcalcifications extending beyond tumor making total size over 15 mm
- Advanced stage breast cancer
- Tumor types: lobular neoplasm, metastatic breast carcinoma, sarcoma, Phyllodes tumor, Paget's disease
- Tumor only ductal carcinoma in situ (DCIS) with microinvasion
- Extensive intraductal component (>25%)
- Known BRCA positive
- Triple-negative breast cancer (ER/PR/HER2 negative)
- Unable to lie prone or supine for 1 hour
- Currently in another investigational treatment or device study that interferes
- No definitive HER2 test per ASCO/CAP guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
City of Hope
Duarte, California, United States, 91010
Withdrawn
2
UC San Diego Health
La Jolla, California, United States, 92037
Actively Recruiting
3
Eisenhower Health
Rancho Mirage, California, United States, 92270
Actively Recruiting
4
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
5
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Withdrawn
6
Summit Health
Florham Park, New Jersey, United States, 07932
Not Yet Recruiting
7
Buffalo General Medical Center
Buffalo, New York, United States, 14203
Actively Recruiting
8
St. Elisabeth-Krankenhaus Köln-Hohenlind
Cologne, Germany, 50935
Actively Recruiting
9
Ichilov | Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Actively Recruiting
10
Breast Centre Zurich
Zurich, Switzerland, 8008
Terminated
11
University Hospital Zurich
Zurich, Switzerland, 8091
Actively Recruiting
12
Charing Cross Hospital, Imperial College Healthcare NHS Trust
London, United Kingdom
Actively Recruiting
13
Churchill Hospital, Oxford University Hospitals NHS Trust
Oxford, United Kingdom
Actively Recruiting
Research Team
E
Eugene Bajorinas
CONTACT
C
Chip Appelbaum
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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