Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors

February 17, 2026 updated by: Novian Health Inc.

Prospective, Multicenter Confirmatory Clinical Evaluation of Novilase® Interstitial Laser Therapy for the Focal Destruction of Malignant Breast Tumors ≤15 mm (BR-003)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects with biopsy-diagnosed malignant breast tumors less than or equal to 15 mm will be invited to participate. Subjects will receive a screening MRI and if eligible will then have laser ablation, followed by MRI and an excision at 4-6 weeks following the laser procedure. This study will be deemed successful if the lower limit of a 95% confidence interval for the proportion of patients who have complete tumor ablation with one Novilase laser ablation procedure at 4-6 weeks post-procedure is greater than the performance goal. Specifically, Novilase will have demonstrated success if the complete tumor ablation rate is greater than 87.85%.

Study Type

Interventional

Enrollment (Estimated)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Cologne, Germany, 50935
        • Recruiting
        • St. Elisabeth-Krankenhaus Köln-Hohenlind
        • Principal Investigator:
          • Claudia Schumacher, MD
  • Israel
      • Tel Aviv, Israel
        • Recruiting
        • Ichilov | Tel Aviv Sourasky Medical Center
        • Principal Investigator:
          • Orit Golan, MD
  • Switzerland
      • Zurich, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich
        • Principal Investigator:
          • Heike Frauchiger-Heuer, MD
      • Zurich, Switzerland, 8008
        • Terminated
        • Breast Centre Zurich
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Charing Cross Hospital, Imperial College Healthcare NHS Trust
        • Contact:
          • Lesley Honeyfield
        • Contact:
          • Cherry Cocol
        • Principal Investigator:
          • Neil Upadhyay, MD
      • Oxford, United Kingdom
        • Recruiting
        • Churchill Hospital, Oxford University Hospitals NHS Trust
        • Contact:
          • Vanessa Fenech
        • Principal Investigator:
          • Pankaj Roy, MD
        • Sub-Investigator:
          • Daniela Ilie, MD
  • United States
    • California
      • Duarte, California, United States, 91010
        • Withdrawn
        • City of Hope
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Health
        • Principal Investigator:
          • Haydee Ojeda-Fournier, MD
      • Rancho Mirage, California, United States, 92270
        • Recruiting
        • Eisenhower Health
        • Principal Investigator:
          • Azadeh Elmi, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • John Lewin, MD
        • Sub-Investigator:
          • Liane Philpotts, MD
        • Sub-Investigator:
          • Liva Andrejeva-Wright, MD
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Withdrawn
        • Walter Reed National Military Medical Center
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Not yet recruiting
        • Summit Health
        • Principal Investigator:
          • Winnie Polen, DO
        • Contact:
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Buffalo General Medical Center
        • Contact:
        • Principal Investigator:
          • Stuti Tambar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Females, aged 18 years and older
  • Able to give written informed consent herself
  • Definitive pathologic diagnosis by needle core biopsy
  • Unifocal malignant tumor (T1a-c, N0-1, M0) that does not exceed 15 mm in longest dimension and measures at least 5 mm away from the skin and chest wall, or can be moved at least 5 mm away from the skin and chest wall by injection of saline or local anesthetic
  • No more than 10 mm of calcifications confined to the tumor on imaging
  • Tumor is well visualized through ultrasound or x-ray mammography imaging and amenable to image-guidance therapy (i.e., 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 is well visualized on MRI
  • Subject with mammographic appearance of overall dense parenchymal tissue may be included, as long as a clearly evident marker is present at tumor site
  • Tumor with less than 25% intraductal component, as determined by core biopsy
  • No clinically significant co-morbidities (e.g., chronic illnesses existing simultaneously with and usually independent of breast cancer) that affect life expectancy
  • Subject weight limited to ≤300 lbs. or ≤136 kg
  • Subject agrees to comply with standard of care radiation or adjuvant therapy as prescribed by physician

Exclusion Criteria:

  • Subject younger than 18 years of age
  • Pregnant or breast-feeding
  • Tumor poorly visualized by ultrasound or x-ray mammography imaging
  • Contraindications to administration of gadolinium-based contrast agent, including: prior allergic reaction to a gadolinium-based contrast agent, moderate to end-stage kidney disease, and/or acute or chronic severe renal insufficiency (Glomerular filtration rate (GFR) <30ml/min/1.73 sq. meters)
  • Contraindications to MRI according to site guidelines (e.g., cardiac pacemaker, metallic implants)
  • History of severe asthma
  • Tumor measuring greater than 15 mm in longest dimension
  • Microcalcifications that extend beyond target tumor such that overall longest dimension of target tumor and calcifications is longer than 15 mm.
  • Advanced stage breast cancer
  • Tumors that are lobular neoplasm, metastatic carcinoma to breast, sarcoma, Phyllodes tumor, or Paget's disease
  • Tumor with only DCIS with microinvasion
  • Extensive intraductal component in lesion (i.e., >25%) as determined by core biopsy
  • Subject who is known to be BRCA positive
  • Tumor that is ER/PR/HER2 negative (TNBC)
  • Inability to lie in prone or supine position for one hour
  • Subject who is currently participating in another investigational treatment, device or drug study through follow up that would interfere with this trial
  • Subject without a definitive HER2 test according to ASCO/CAP guidelines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Novilase Laser Ablation and excision
Eligible subject will receive image-guided laser ablation of a targeted malignant breast tumor. At 4-6 weeks following the ablation, she will receive a MRI and excision. Pathology and MRI will determine rate of complete ablation. Subject is expected to proceed with radiation and/or adjuvant therapy per standard of care.
Device: Novilase Laser ablation
Image-guided, percutaneous laser ablation of breast tumors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of target tumors completely ablated in one procedure
Time Frame: 4-6 weeks
Efficacy: Rate of complete ablation by Novilase laser ablation
4-6 weeks
Frequency of adverse events (categorized using the NCI Common Terminology for Adverse Events (CTCAE) v4.0 guidelines) post-laser ablation and post-surgery
Time Frame: 4-6 weeks
Safety: frequency of AEs
4-6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported rate of return to activities of daily living post-laser ablation and post-surgery
Time Frame: 4-6 weeks
Rate of recovery
4-6 weeks
Physician reported cosmetic satisfaction, utilizing the 4-point scoring system of breast cosmesis in protocol (e.g., excellent, good, fair, poor) post-laser ablation and post-surgery (4-6 weeks)
Time Frame: 4-6 weeks
Post-procedure cosmetic satisfaction
4-6 weeks
Health related quality of life outcome measures at three timepoints via EORTC QLQ-C30 & QLQ-BR23 questionnaire (baseline and 4-6 weeks post-laser ablation and post-surgery)
Time Frame: 4-6 weeks
Health-related quality of life outcome measures
4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novian Health Inc.

Investigators

  • Principal Investigator: John Lewin, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

January 23, 2018

First Submitted That Met QC Criteria

March 6, 2018

First Posted (Actual)

March 13, 2018

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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