Immunostimulating Interstitial Laser Thermotherapy in Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03039127|
Recruitment Status : Completed
First Posted : February 1, 2017
Last Update Posted : January 30, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Device: Immunostimulating Interstitial Laser Thermotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Interstitial Laser Thermotherapy (imILT) as a Treatment Option in Breast Cancer Patients Not Suitable for Surgical Excision|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||August 2018|
Immunostimulating Interstitial Laser Thermotherapy (imILT)
Device: Immunostimulating Interstitial Laser Thermotherapy
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.
- Treatment effect by radiology [ Time Frame: 9 months ]Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)
- Safety (adverse events) [ Time Frame: 9 months ]Evaluation of adverse events and laboratory analyses.
- Usability (user evaluation of instrument) [ Time Frame: 9 months ]Analysis of instrument and user questionnaires relating to the ease of use.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039127
|Nottingham Breast Cancer Institute|
|Nottingham, United Kingdom, NG5 1PB|
|Principal Investigator:||Kristjan S Asgeirsson, MD||Nottingham Breast Institute|