Novilase Laser Therapy for Breast Tumors
This study is evaluating Novilase® Laser therapy for treating malignant (cancerous) breast tumors that are 15mm or smaller. Researchers want to see if this laser treatment can completely destroy these tumors in one procedure. You might be able to join if you are a woman, 18 or older, with a specific type of breast cancer diagnosis. The study aims to show that Novilase can completely destroy tumors in more than 87.85% of patients, which would be comparable to the success rates of standard surgery (lumpectomy). The current status of this study is unclear.
- Study design
- This is an interventional study planning to enroll 122 women. It is designed to evaluate the effectiveness of Novilase laser ablation against a performance goal for standard surgery.
- What's involved
- You would receive a screening MRI, then laser ablation, followed by another MRI and a surgical removal of the treated area 4-6 weeks after the laser procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be measured 4-6 weeks after the laser procedure and after surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT03463954
Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors
Recruiting
NAAges 18+InterventionalTreatmentNovian Health Inc.
~122 participants
Updated 2026-02-19 on ClinicalTrials.gov
What's tested:Novilase Laser ablation
At a glance
Recruiting sites
9 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of target tumors completely ablated in one procedure
Measured over 4-6 weeks
+1 more outcome measured
Conditions
Where it's being run
13 sites across 9 statesCalifornia3
Switzerland2
United Kingdom2
Connecticut1
Maryland1
New Jersey1
New York1
Germany1
Study leadership
- John Lewin, MD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Percentage of target tumors completely ablated in one procedure4-6 weeks
Efficacy: Rate of complete ablation by Novilase laser ablation
- Frequency of adverse events (categorized using the NCI Common Terminology for Adverse Events (CTCAE) v4.0 guidelines) post-laser ablation and post-surgery4-6 weeks
Safety: frequency of AEs