Breast Neoplasms
Conditions
Keywords
Hyperthermia, Laser Coagulation, Laser Therapy, Induced
Brief summary
Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. In laboratory animals the imILT method has also been shown to induce a so called abscopal effect. This means that when one tumor is treated with imILT other, untreated, tumors also decrease in size. The immunologic response has previously been characterized in breast cancer patients after receiving imILT treatment , and presumed abscopal effects induced by imILT have also been described in a malignant melanoma patient. The purpose of this trial is to investigate the functionality and safety of the imILT treatment method in patients diagnosed with breast cancer. The treatment method has successfully been used for treatment of patients with breast cancer and malignant melanoma. Treatment of breast cancer patients caused an increase of cytotoxic T lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor border. Regulatory T lymphocytes decreased in the regional lymph nodes. This trial is explorative, prospective, open and non-randomized. Five breast cancer patients will be treated in this trial, which is estimated to be carried out during a time period of 9 months.
Interventions
Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response.
Sponsors
Nottingham University Hospitals NHS Trust
Clinical Laserthermia Systems AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Have histologically confirmed breast cancer 2. Hormone receptor positive or negative 3. Have assessable tumour by MRI or ultrasound 4. Are patients deemed unfit for surgical excision of tumour under general anaesthetic. 5. Have been given informed verbal and written consent for participation in the trial 6. Have stable hematologic, renal and hepatic functions.
Exclusion criteria
1. Are known to be HIV positive 2. Have active autoimmune disease 3. Are on corticosteroid medication 4. Have evidence of bleeding diathesis or coagulopathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment effect by radiology | 9 months | Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety (adverse events) | 9 months | Evaluation of adverse events and laboratory analyses. |
| Usability (user evaluation of instrument) | 9 months | Analysis of instrument and user questionnaires relating to the ease of use. |
Countries
United Kingdom
Outcome results
None listed