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

NCT03463954

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

N/A

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: BR-003
  • NCT ID: NCT03463954

Conditions

  • Malignant Neoplasm of Breast

Purpose

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%.
    

Trial Arms

NameTypeDescriptionInterventions
Novilase Laser Ablation and excisionExperimentalEligible 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.

    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 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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Percentage of target tumors completely ablated in one procedure
    Time Frame:4-6 weeks
    Safety Issue:
    Description:Efficacy: Rate of complete ablation by Novilase laser ablation

    Secondary Outcome Measures

    Measure:Patient reported rate of return to activities of daily living post-laser ablation and post-surgery
    Time Frame:4-6 weeks
    Safety Issue:
    Description:Rate of recovery
    Measure: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
    Safety Issue:
    Description:Post-procedure cosmetic satisfaction
    Measure: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
    Safety Issue:
    Description:Health-related quality of life outcome measures

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:Novian Health Inc.

    Trial Keywords

    • less than or equal to 15 mm

    Last Updated