BR-003 Confirmatory Study Novilase Ablation Malignant Breast Tumours
Research type
Research Study
Full title
Prospective Multicenter Confirmatory Clinical Evaluation of Novilase® Interstitial Laser Therapy for the Focal Destruction of Malignant Breast Tumours ≤15 mm (BR-003)
IRAS ID
242609
Contact name
Pankaj Roy
Contact email
Sponsor organisation
Novian Health Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 31 days
Research summary
This pivotal study is a confirmatory study that will evaluate the effectiveness of Novilase laser ablation in focal destruction of a target breast cancer tumour (less than or equal to 15mm) prior to proceeding with radiation and/or adjuvant therapy, and evaluate the safety of laser ablation.
Complete focal destruction of the tumour by Novilase laser ablation in one procedure will be evidenced by MR imaging at 4 to 6 weeks post ablation and pathology of the excised specimen, and the rate of complete ablation will be compared to a performance goal (PG) for the standard of care lumpectomy. The PG of 80% is based on the ASBrS goal for surgeons by 2020. 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%.
Patients will benefit from heightened imaging surveillance due to the requirement of a screen-in breast MRI and a MRI at 4 to 6 weeks post procedure.All subjects are expected to complete any prescribed radiation and/or adjuvant therapy. All imaging following radiation therapy will be as per standard of care.
To ensure subjects meet inclusion criteria, all consented subjects will have a screen-in breast MRI to determine eligibility.REC name
Wales REC 6
REC reference
22/WA/0229
Date of REC Opinion
19 Aug 2022
REC opinion
Favourable Opinion