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

NCT03463954 | Recruiting FDA Device

• 1 other identifier: BR-003
• Study Type: interventional
• Target: 122
• Locations: 5 countries
• Sites: 13

Brief Summary

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

Malignant Neoplasm of Breast

Keywords

less than or equal to 15 mm

Outcome Measures

Primary Outcomes (2)

• Percentage of target tumors completely ablated in one procedure

  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

  Safety: frequency of AEs

  4-6 weeks

Secondary Outcomes (3)

• Patient reported rate of return to activities of daily living post-laser ablation and post-surgery

  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)

  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)

  4-6 weeks

Study Arms (1)

Novilase Laser Ablation and excision

EXPERIMENTAL

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

Interventions

Novilase Laser ablation DEVICE

Image-guided, percutaneous laser ablation of breast tumors

Novilase Laser Ablation and excision

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novian Health Inc.: lead

Study Sites (13)

City of Hope

Duarte, California, 91010, United States

WITHDRAWN

UC San Diego Health

La Jolla, California, 92037, United States

RECRUITING

Eisenhower Health

Rancho Mirage, California, 92270, United States

RECRUITING

Yale University

New Haven, Connecticut, 06511, United States

RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

WITHDRAWN

Summit Health

Florham Park, New Jersey, 07932, United States

NOT YET RECRUITING

Buffalo General Medical Center

Buffalo, New York, 14203, United States

RECRUITING

St. Elisabeth-Krankenhaus Köln-Hohenlind

Cologne, 50935, Germany

RECRUITING

Ichilov | Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

Breast Centre Zurich

Zurich, 8008, Switzerland

TERMINATED

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

Charing Cross Hospital, Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

Churchill Hospital, Oxford University Hospitals NHS Trust

Oxford, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• John Lewin, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugene Bajorinas

CONTACT

3122667200; ebajorinas@novianhealth.com

Chip Appelbaum

CONTACT

3122667200; info@novianhealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: March 13, 2018
• Study Start: August 9, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: February 19, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); GB (2); IL (1); US (7); CH (2)