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Immunostimulating Interstitial Laser Thermotherapy in Breast Cancer

Primary Purpose

Breast Neoplasms

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Immunostimulating Interstitial Laser Thermotherapy
Sponsored by
Clinical Laserthermia Systems AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Hyperthermia, Laser Coagulation, Laser Therapy, Induced

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nottingham Breast Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

imILT

Arm Description

Immunostimulating Interstitial Laser Thermotherapy (imILT)

Outcomes

Primary Outcome Measures

Treatment effect by radiology
Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)

Secondary Outcome Measures

Safety (adverse events)
Evaluation of adverse events and laboratory analyses.
Usability (user evaluation of instrument)
Analysis of instrument and user questionnaires relating to the ease of use.

Full Information

First Posted
June 29, 2016
Last Updated
July 2, 2021
Sponsor
Clinical Laserthermia Systems AB
Collaborators
Nottingham University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03039127
Brief Title
Immunostimulating Interstitial Laser Thermotherapy in Breast Cancer
Official Title
Interstitial Laser Thermotherapy (imILT) as a Treatment Option in Breast Cancer Patients Not Suitable for Surgical Excision
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped in agreement with investigator due to slow recruitment.
Study Start Date
June 2016 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Laserthermia Systems AB
Collaborators
Nottingham University Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Hyperthermia, Laser Coagulation, Laser Therapy, Induced

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
imILT
Arm Type
Experimental
Arm Description
Immunostimulating Interstitial Laser Thermotherapy (imILT)
Intervention Type
Device
Intervention Name(s)
Immunostimulating Interstitial Laser Thermotherapy
Intervention 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.
Primary Outcome Measure Information:
Title
Treatment effect by radiology
Description
Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Safety (adverse events)
Description
Evaluation of adverse events and laboratory analyses.
Time Frame
9 months
Title
Usability (user evaluation of instrument)
Description
Analysis of instrument and user questionnaires relating to the ease of use.
Time Frame
9 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have histologically confirmed breast cancer Hormone receptor positive or negative Have assessable tumour by MRI or ultrasound Are patients deemed unfit for surgical excision of tumour under general anaesthetic. Have been given informed verbal and written consent for participation in the trial Have stable hematologic, renal and hepatic functions. Exclusion Criteria: Are known to be HIV positive Have active autoimmune disease Are on corticosteroid medication Have evidence of bleeding diathesis or coagulopathy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristjan S Asgeirsson, MD
Organizational Affiliation
Nottingham Breast Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nottingham Breast Cancer Institute
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26504041
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.
Results Reference
result
PubMed Identifier
21400025
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.
Results Reference
result
PubMed Identifier
16091763
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.
Results Reference
result
PubMed Identifier
8846867
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.
Results Reference
result
PubMed Identifier
22388047
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.
Results Reference
result
PubMed Identifier
14666667
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.
Results Reference
result

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Immunostimulating Interstitial Laser Thermotherapy in Breast Cancer

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