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Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

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Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

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Neuroepithelioma

Immunostimulating Interstitial Laser Thermotherapy (imILT)

Immunostimulating Interstitial Laser Thermotherpy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response.

Immunostimulating Interstitial Laser Thermotherapy

Johan Hansson, MD PhD

Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. Immunostimulating Interstitial Laser Thermotherpy (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 malignant melanoma. The inflammatory process, following on the treatment, will also be described in order to provide a more in depth knowledge of the treatment for this indication. The purpose is also to evaluate efficiency when it comes to local tumor destruction as well as understanding of the subsequent immunological effects. Since immunologically based treatment of malignant melanoma is under intense review with so called "immune checkpoint inhibitors" this trial will also provide valuable information on how imILT, in the future, could be combined with these new and, for some patients, very effective treatment regimens.

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 malignant melanoma patients stage III - IV will be treated in this trial, which is estimated to be carried out during a time period of 12 months.

Immunostimulating Interstitial Laser Thermotherapy in Malignant Melanoma

Exploratory Study on Immunostimulating Interstitial Laser Thermotherapy in Malignant Melanoma

Evaluation of the laser system by analysis of treatment logs of the device.

Evaluation of the laser system by analysis of user questionnaire.

Measurement of tumor burden by irRC criteria.

Quantification of cellular infiltrate and activation markers by immunohistochemistry and flow cytometry.

Clinical Laserthermia Systems AB

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.

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 evaluate efficiency when it comes to local tumor destruction of the imILT treatment method in patients diagnosed with solid tumors. The purpose is also to investigate the functionality and safety as well as understanding of the subsequent immunological effects. Since immunologically based treatment of various solid tumors is under intense review with so called "immune checkpoint inhibitors" this trial will also provide valuable information on how imILT, in the future, could be combined with these new and, for some patients, very effective treatment regimens.

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. Thirty patients diagnosed with solid tumors will be treated in this trial, which is estimated to be carried out during a time period of 18 months.

Immunostimulating Interstitial Laser Thermotherapy in Solid Cancers

To Evaluate the Safety & Palliative Treatment Effect on Patients With Solid Cancers by Immunostimulating Interstitial Laser Thermotherapy (imILT)

Quantification of cellular infiltrate and activation markers by immunohistochemistry.

Quantification of cellular infiltrate and activation markers by flow cytometry.

Evaluation of pain is performed using the visual analog scale (VAS).

Evaluation of Quality of Life is evaluated using a standardized questionnaire (EORTC, general).

Breast Neoplasms

Breast Diseases

Kristjan S Asgeirsson, MD

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.

Immunostimulating Interstitial Laser Thermotherapy in Breast Cancer

Interstitial Laser Thermotherapy (imILT) as a Treatment Option in Breast Cancer Patients Not Suitable for Surgical Excision

Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)

Evaluation of adverse events and laboratory analyses.

Analysis of instrument and user questionnaires relating to the ease of use.

Nottingham University Hospitals NHS Trust

Digestive System Diseases

Gland and Hormone Related Diseases

Carcinoma

Pancreatic Neoplasms

Pancreatic Cancer

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 purpose of this trial is to evaluate efficiency when it comes to local tumor destruction of the imILT treatment method in patients diagnosed with pancreatic cancer. The purpose is also to investigate the functionality and safety as well as understanding of the subsequent immunological effects.

This trial is prospective, open and non-randomized. Five patients diagnosed with pancreatic cancer will be treated in this trial, which is estimated to be carried out during a time period of 36 months.

Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

Prospective, Open, Non Comparative Trial to Evaluate Safety and Feasibility of Immunostimulating Interstitial Laser Thermotherapy (imILT) in Stage III Pancreatic Carcinoma

Analysis of the percentage of patients with no new oncological events.

Evaluation of Quality of Life is evaluated using standardized questionnaires.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunostimulating Interstitial Laser Thermotherapy in Malignant Melanoma	NCT02650492	Melanoma Malignant Melan...	Immunostimulati...	18 Years -	Clinical Laserthermia Systems AB
Immunostimulating Interstitial Laser Thermotherapy in Solid Cancers	NCT02690428	Neoplasms	Immunostimulati...	18 Years -	Clinical Laserthermia Systems AB
Immunostimulating Interstitial Laser Thermotherapy in Breast Cancer	NCT03039127	Breast Neoplasm...	Immunostimulati...	-	Clinical Laserthermia Systems AB
Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer	NCT02973217	Neoplasms Pancr...	Immunostimulati...	18 Years - 80 Years	Clinical Laserthermia Systems AB

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