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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Novilase laser treatment to destroy breast cancer tumors that are 15 mm or smaller. It is for women age 18 and older. Results will be compared with a success goal based on lumpectomy, surgery that removes the tumor.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older who can give written consent themselves.
  • Breast cancer confirmed by a core needle biopsy, which removes small tissue samples.
  • One cancer tumor, 15 mm or smaller, with no distant spread. It must be at least 5 mm from the skin and chest wall, or be moved that far by an injection.
  • Tumor is clearly seen on MRI and on ultrasound or mammograms so treatment can be guided by images. Dense breast tissue is allowed if a marker at the tumor is clearly seen.
  • Calcium deposits are only inside the tumor and cover no more than 10 mm.
  • Biopsy shows that less than 25% of the tumor is cancer within the milk ducts.
  • Weight is 300 pounds or less, with no other major illnesses that affect life expectancy.
  • Willing to follow the doctor's plan for standard radiation or other treatment.

Who can't join

  • Pregnant or breastfeeding.
  • Cannot safely have an MRI or its contrast dye, including because of a past dye allergy, kidney disease, or certain metal implants; or has a history of severe asthma.
  • Tumor is larger than 15 mm, is not clearly seen on ultrasound or mammograms, or has calcium deposits outside it that bring the total size above 15 mm.
  • Advanced breast cancer or certain tumor types: lobular tumors, cancer spread to the breast from elsewhere, sarcoma, Phyllodes tumor, or Paget's disease.
  • Only DCIS with microinvasion—cancer in milk ducts with tiny areas spreading outside them—or more than 25% of the tumor is cancer within milk ducts.
  • Known positive BRCA gene test; triple-negative cancer, which lacks ER, PR, and HER2 markers; or no definite HER2 test result that meets required guidelines.
  • Cannot lie on the stomach or back for one hour.
  • Taking part in another experimental treatment, device, or drug study that would interfere with this study through follow-up.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (7)

CA

CT

MD

NJ

NY