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Immunostimulating Interstitial Laser Thermotherapy in Breast Cancer

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ClinicalTrials.gov Identifier: NCT03039127
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
Nottingham University Hospitals NHS Trust
Information provided by (Responsible Party):
Clinical Laserthermia Systems AB

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.


Condition or disease Intervention/treatment Phase
Breast Neoplasms Device: Immunostimulating Interstitial Laser Thermotherapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interstitial Laser Thermotherapy (imILT) as a Treatment Option in Breast Cancer Patients Not Suitable for Surgical Excision
Study Start Date : June 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: imILT
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.




Primary Outcome Measures :
  1. Treatment effect by radiology [ Time Frame: 9 months ]
    Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)


Secondary Outcome Measures :
  1. Safety (adverse events) [ Time Frame: 9 months ]
    Evaluation of adverse events and laboratory analyses.

  2. Usability (user evaluation of instrument) [ Time Frame: 9 months ]
    Analysis of instrument and user questionnaires relating to the ease of use.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Stefan Åström, PhD +46 (0)70 863 4909 stefan@astromresearch.com

Locations
United Kingdom
Nottingham Breast Cancer Institute Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Kristjan S Asgeirsson, MD         
Sponsors and Collaborators
Clinical Laserthermia Systems AB
Nottingham University Hospitals NHS Trust
Investigators
Principal Investigator: Kristjan S Asgeirsson, MD Nottingham Breast Institute

Publications of Results:
Responsible Party: Clinical Laserthermia Systems AB
ClinicalTrials.gov Identifier: NCT03039127     History of Changes
Other Study ID Numbers: CTP-2015-009
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Clinical Laserthermia Systems AB:
Hyperthermia
Laser Coagulation
Laser Therapy
Induced

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases