Interstitial Laser Thermotherapy (imILT) in Early Stage Breast Cancer
Research type
Research Study
Full title
A study of Interstitial Laser Thermotherapy (imILT) Treatment in Early Stage Breast Cancer
IRAS ID
228515
Contact name
Kristján Skúli Ásgeirsson
Contact email
Sponsor organisation
Clinical Laserthermia Systems AB (CLS)
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
Study Title: Interstitial Laser Thermotherapy (imILT) as a Treatment Option in Early Stage Breast Cancer.
The trial is a prospective, open label, single arm study to investigate imILT (immunostimulating interstitial laser thermotherapy). imILT is a form of laser-mediated thermotherapy which involves heating the tumour via a laser beam controlled at a steady-state target temperature of 46°C for 30 minutes in the peripheral parts of the treated area. Results of clinical trials suggest that imILT can also induce a systemic anti-tumour immune effect.
The objective is to assess the local ablative effect of imILT on early stage breast cancer, and to provide additional evidence of patient safety and apparatus usability/feasibility. Patients with early stage breast cancer (tumour size </= 20mm by ultrasound measurement) will be recruited from Nottingham Breast Institute. Patients having surgery as first modality of their treatment will be eligible and offered imILT treatment within 7-10 days of their diagnosis. At the time of imILT treatment, core biopsies will be taken for oncotype DX testing primarily to assess any benefit of adjuvant chemotherapy. These core biopsies are normally taken at surgery. The patients will have their surgery as per standard of care, which will be no later than 3 weeks later.
A sufficient number of subjects will be recruited to obtain 10 subjects with evaluable data. Assessments will include MRI scans, vital signs, performance status, adverse events, completion of a patient reported questionnaire, Core biopsy for Oncotype Dx, clip marker insertion and Histological analysis. The trial, including recruitment, is anticipated to last for 6 months. Trial duration for each patient will be a maximum of 7 weeks and will include a total of 4 hospital visits, 2 of these visits will be standard of care and 2 will be additional to standard of care (the screening visit and the imILT treatment visit).
Participants for the trial will be recruited from the Nottingham Breast Institute and treated as out-patients. The trial is funded by Clinical Laserthermia Systems AB (CLS).
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0229
Date of REC Opinion
17 Aug 2017
REC opinion
Further Information Favourable Opinion