Interstitial laser thermotherapy (imILT) treatment of breast cancer
Research type
Research Study
Full title
Interstitial laser thermotherapy (imILT) as a treatment option in breast cancer patients not suitable for surgical excision\n
IRAS ID
189032
Contact name
Kristján Skúli Ásgeirsson
Contact email
Sponsor organisation
Clinical Laserthermia Systems AB (CLS)
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Study Title: Interstitial laser thermotherapy (imILT) as a treatment option in breast cancer patients not suitable for surgical excision\n\nThe trial is a prospective, open label, single arm study to investigate imILT (immunostimulating interstitial laser thermotherapy) as a treatment option in 5 breast cancer patients who are considered unfit for surgical tumour excision under general anaesthetic. 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 trial has been designed to analyse the local effect of imILT, determine if there is a distant and immune-mediated effect on non-laser treated tumour mass, and to provide additional evidence of patient safety and apparatus usability. Assessments will include MRI scans, vital signs, adverse events and completion of a patient reported VAS (visual analogue scale). Primary and secondary endpoints will be determined using The Response Evaluation Criteria in Solid Tumours (RECIST) and, as applicable, the Immune-Related Response Criteria (irRC) in combination with clinical assessment at 1, 2 and 3 months after treatment with imILT . The trial, including recruitment, is anticipated to last for 12 months. Trial duration for each patient will be a maximum of 6 months and will include a maximum of 3 imILT treatments and 7 hospital visits. \n\nParticipants 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
15/EM/0474
Date of REC Opinion
8 Jan 2016
REC opinion
Further Information Favourable Opinion