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

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ClinicalTrials.gov Identifier: NCT03463954
Recruitment Status : Not yet recruiting
First Posted : March 13, 2018
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Novian Health Inc.

Tracking Information
First Submitted Date  ICMJE January 23, 2018
First Posted Date  ICMJE March 13, 2018
Last Update Posted Date March 3, 2021
Estimated Study Start Date  ICMJE August 2021
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2018)
  • Percentage of target tumors completely ablated in one procedure [ Time Frame: 4-6 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-surgery [ Time Frame: 4-6 weeks ]
    Safety: frequency of AEs
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2018)
  • Patient reported rate of return to activities of daily living post-laser ablation and post-surgery [ Time Frame: 4-6 weeks ]
    Rate of recovery
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors
Official Title  ICMJE Prospective, Multicenter Confirmatory Clinical Evaluation of Novilase® Interstitial Laser Therapy for the Focal Destruction of Malignant Breast Tumors ≤15 mm (BR-003)
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Neoplasm of Breast
Intervention  ICMJE Device: Novilase Laser ablation
Image-guided, percutaneous laser ablation of breast tumors
Study Arms  ICMJE 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.
Intervention: Device: Novilase Laser ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 6, 2018)		 122
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 who falls into high risk group on Caprini Risk Assessment for deep vein thrombosis (DVT) and requires Lovenox (Enoxaparin)
  • Subject without a definitive HER2 test according to ASCO/CAP guidelines
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eugene Bajorinas, MBA 3122667200 ebajorinas@novianhealth.com
Contact: Marti DeLay 3122667200 mdelay@novianhealth.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03463954
Other Study ID Numbers  ICMJE BR-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Novian Health Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novian Health Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barbara Schwartzberg, MD Rose Medical Center
PRS Account Novian Health Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP