RECRUITING

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

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Conditions

Malignant Neoplasm of Breastless than or equal to 15 mm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-08-09
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03463954

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Females, aged 18 years and older
  2. * Able to give written informed consent herself
  3. * Definitive pathologic diagnosis by needle core biopsy
  4. * 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
  5. * No more than 10 mm of calcifications confined to the tumor on imaging
  6. * 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)
  7. * Tumor is well visualized on MRI
  8. * Subject with mammographic appearance of overall dense parenchymal tissue may be included, as long as a clearly evident marker is present at tumor site
  9. * Tumor with less than 25% intraductal component, as determined by core biopsy
  10. * No clinically significant co-morbidities (e.g., chronic illnesses existing simultaneously with and usually independent of breast cancer) that affect life expectancy
  11. * Subject weight limited to ≤300 lbs. or ≤136 kg
  12. * Subject agrees to comply with standard of care radiation or adjuvant therapy as prescribed by physician
  1. * Subject younger than 18 years of age
  2. * Pregnant or breast-feeding
  3. * Tumor poorly visualized by ultrasound or x-ray mammography imaging
  4. * 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)
  5. * Contraindications to MRI according to site guidelines (e.g., cardiac pacemaker, metallic implants)
  6. * History of severe asthma
  7. * Tumor measuring greater than 15 mm in longest dimension
  8. * Microcalcifications that extend beyond target tumor such that overall longest dimension of target tumor and calcifications is longer than 15 mm.
  9. * Advanced stage breast cancer
  10. * Tumors that are lobular neoplasm, metastatic carcinoma to breast, sarcoma, Phyllodes tumor, or Paget's disease
  11. * Tumor with only DCIS with microinvasion
  12. * Extensive intraductal component in lesion (i.e., \>25%) as determined by core biopsy
  13. * Subject who is known to be BRCA positive
  14. * Tumor that is ER/PR/HER2 negative (TNBC)
  15. * Inability to lie in prone or supine position for one hour
  16. * Subject who is currently participating in another investigational treatment, device or drug study through follow up that would interfere with this trial
  17. * Subject without a definitive HER2 test according to ASCO/CAP guidelines

Contacts and Locations

Study Contact

Eugene Bajorinas
CONTACT
3122667200
ebajorinas@novianhealth.com
Chip Appelbaum
CONTACT
3122667200
info@novianhealth.com

Principal Investigator

John Lewin, MD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
UC San Diego Health
La Jolla, California, 92037
United States
Yale University
New Haven, Connecticut, 06511
United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
United States
Summit Health
Florham Park, New Jersey, 07932
United States
Buffalo General Medical Center
Buffalo, New York, 14203
United States

Collaborators and Investigators

Sponsor: Novian Health Inc.

  • John Lewin, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-09
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2023-08-09
Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

  • less than or equal to 15 mm

Additional Relevant MeSH Terms

  • Malignant Neoplasm of Breast