Status:
RECRUITING
Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors
Lead Sponsor:
Novian Health Inc.
Conditions:
Malignant Neoplasm of Breast
Eligibility:
FEMALE
18+ years
Phase:
NA
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 eval...
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, ...
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
Key Trial Info
Start Date :
August 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2027
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT03463954
Start Date
August 9 2023
End Date
March 30 2027
Last Update
October 28 2025
Active Locations (12)
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1
City of Hope
Duarte, California, United States, 91010
2
UC San Diego Health
La Jolla, California, United States, 92037
3
Eisenhower Health
Rancho Mirage, California, United States, 92270
4
Yale University
New Haven, Connecticut, United States, 06511