<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03039127</url>
  </required_header>
  <id_info>
    <org_study_id>CTP-2015-009</org_study_id>
    <nct_id>NCT03039127</nct_id>
  </id_info>
  <brief_title>Immunostimulating Interstitial Laser Thermotherapy in Breast Cancer</brief_title>
  <official_title>Interstitial Laser Thermotherapy (imILT) as a Treatment Option in Breast Cancer Patients Not Suitable for Surgical Excision</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Laserthermia Systems AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nottingham University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Clinical Laserthermia Systems AB</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue.&#xD;
      Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of&#xD;
      thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a&#xD;
      tumor specific immunologic response. In laboratory animals the imILT method has also been&#xD;
      shown to induce a so called abscopal effect. This means that when one tumor is treated with&#xD;
      imILT other, untreated, tumors also decrease in size. The immunologic response has previously&#xD;
      been characterized in breast cancer patients after receiving imILT treatment , and presumed&#xD;
      abscopal effects induced by imILT have also been described in a malignant melanoma patient.&#xD;
&#xD;
      The purpose of this trial is to investigate the functionality and safety of the imILT&#xD;
      treatment method in patients diagnosed with breast cancer.&#xD;
&#xD;
      The treatment method has successfully been used for treatment of patients with breast cancer&#xD;
      and malignant melanoma. Treatment of breast cancer patients caused an increase of cytotoxic T&#xD;
      lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor border.&#xD;
      Regulatory T lymphocytes decreased in the regional lymph nodes.&#xD;
&#xD;
      This trial is explorative, prospective, open and non-randomized. Five breast cancer patients&#xD;
      will be treated in this trial, which is estimated to be carried out during a time period of 9&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study was stopped in agreement with investigator due to slow recruitment.&#xD;
  </why_stopped>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment effect by radiology</measure>
    <time_frame>9 months</time_frame>
    <description>Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety (adverse events)</measure>
    <time_frame>9 months</time_frame>
    <description>Evaluation of adverse events and laboratory analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability (user evaluation of instrument)</measure>
    <time_frame>9 months</time_frame>
    <description>Analysis of instrument and user questionnaires relating to the ease of use.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Breast Neoplasms</condition>
  <arm_group>
    <arm_group_label>imILT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Immunostimulating Interstitial Laser Thermotherapy (imILT)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Immunostimulating Interstitial Laser Thermotherapy</intervention_name>
    <description>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.</description>
    <arm_group_label>imILT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have histologically confirmed breast cancer&#xD;
&#xD;
          2. Hormone receptor positive or negative&#xD;
&#xD;
          3. Have assessable tumour by MRI or ultrasound&#xD;
&#xD;
          4. Are patients deemed unfit for surgical excision of tumour under general anaesthetic.&#xD;
&#xD;
          5. Have been given informed verbal and written consent for participation in the trial&#xD;
&#xD;
          6. Have stable hematologic, renal and hepatic functions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Are known to be HIV positive&#xD;
&#xD;
          2. Have active autoimmune disease&#xD;
&#xD;
          3. Are on corticosteroid medication&#xD;
&#xD;
          4. Have evidence of bleeding diathesis or coagulopathy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristjan S Asgeirsson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nottingham Breast Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nottingham Breast Cancer Institute</name>
      <address>
        <city>Nottingham</city>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Haraldsdottir KH, Ingvar C, Stenram U, Tranberg KG. Long-term Follow-up After Interstitial Laser Thermotherapy of Breast Cancer. Anticancer Res. 2015 Nov;35(11):6147-52.</citation>
    <PMID>26504041</PMID>
  </results_reference>
  <results_reference>
    <citation>Haraldsdottir KH, Ivarsson K, Jansner K, Stenram U, Tranberg KG. Changes in immunocompetent cells after interstitial laser thermotherapy of breast cancer. Cancer Immunol Immunother. 2011 Jun;60(6):847-56. doi: 10.1007/s00262-011-0992-8. Epub 2011 Mar 13.</citation>
    <PMID>21400025</PMID>
  </results_reference>
  <results_reference>
    <citation>Ivarsson K, Myllymaki L, Jansner K, Stenram U, Tranberg KG. Resistance to tumour challenge after tumour laser thermotherapy is associated with a cellular immune response. Br J Cancer. 2005 Aug 22;93(4):435-40. doi: 10.1038/sj.bjc.6602718.</citation>
    <PMID>16091763</PMID>
  </results_reference>
  <results_reference>
    <citation>Tranberg KG, Moller PH, Hannesson P, Stenram U. Interstitial laser treatment of malignant tumours: initial experience. Eur J Surg Oncol. 1996 Feb;22(1):47-54. doi: 10.1016/s0748-7983(96)91451-1.</citation>
    <PMID>8846867</PMID>
  </results_reference>
  <results_reference>
    <citation>Tranberg KG, Myllymaki L, Moller PH, Ivarsson K, Sjogren HO, Stenram U. Interstitial laser thermotherapy of a rat liver adenocarcinoma. J Xray Sci Technol. 2002 Jan 1;10(3):177-85.</citation>
    <PMID>22388047</PMID>
  </results_reference>
  <results_reference>
    <citation>Ivarsson K, Myllymaki L, Jansner K, Bruun A, Stenram U, Tranberg KG. Heat shock protein 70 (HSP70) after laser thermotherapy of an adenocarcinoma transplanted into rat liver. Anticancer Res. 2003 Sep-Oct;23(5A):3703-12.</citation>
    <PMID>14666667</PMID>
  </results_reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 29, 2016</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>July 2, 2021</last_update_submitted>
  <last_update_submitted_qc>July 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hyperthermia</keyword>
  <keyword>Laser Coagulation</keyword>
  <keyword>Laser Therapy</keyword>
  <keyword>Induced</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03039127
org study id: CTP-2015-009
nct id: NCT03039127
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment effect by radiology
time frame: 9 months
description: Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)
measure: Safety (adverse events)
time frame: 9 months
description: Evaluation of adverse events and laboratory analyses.
measure: Usability (user evaluation of instrument)
time frame: 9 months
description: Analysis of instrument and user questionnaires relating to the ease of use.
arm group label: imILT
arm group type: Experimental
description: Immunostimulating Interstitial Laser Thermotherapy (imILT)
intervention type: Device
intervention name: Immunostimulating Interstitial Laser Thermotherapy
description: 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.
arm group label: imILT
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Kristjan S Asgeirsson, MD
role: Principal Investigator
affiliation: Nottingham Breast Institute
facility: 
country: United Kingdom
citation: Haraldsdottir KH, Ingvar C, Stenram U, Tranberg KG. Long-term Follow-up After Interstitial Laser Thermotherapy of Breast Cancer. Anticancer Res. 2015 Nov;35(11):6147-52.
PMID: 26504041
citation: Haraldsdottir KH, Ivarsson K, Jansner K, Stenram U, Tranberg KG. Changes in immunocompetent cells after interstitial laser thermotherapy of breast cancer. Cancer Immunol Immunother. 2011 Jun;60(6):847-56. doi: 10.1007/s00262-011-0992-8. Epub 2011 Mar 13.
PMID: 21400025
citation: Ivarsson K, Myllymaki L, Jansner K, Stenram U, Tranberg KG. Resistance to tumour challenge after tumour laser thermotherapy is associated with a cellular immune response. Br J Cancer. 2005 Aug 22;93(4):435-40. doi: 10.1038/sj.bjc.6602718.
PMID: 16091763
citation: Tranberg KG, Moller PH, Hannesson P, Stenram U. Interstitial laser treatment of malignant tumours: initial experience. Eur J Surg Oncol. 1996 Feb;22(1):47-54. doi: 10.1016/s0748-7983(96)91451-1.
PMID: 8846867
citation: Tranberg KG, Myllymaki L, Moller PH, Ivarsson K, Sjogren HO, Stenram U. Interstitial laser thermotherapy of a rat liver adenocarcinoma. J Xray Sci Technol. 2002 Jan 1;10(3):177-85.
PMID: 22388047
citation: Ivarsson K, Myllymaki L, Jansner K, Bruun A, Stenram U, Tranberg KG. Heat shock protein 70 (HSP70) after laser thermotherapy of an adenocarcinoma transplanted into rat liver. Anticancer Res. 2003 Sep-Oct;23(5A):3703-12.
PMID: 14666667
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No