Immunostimulating Interstitial Laser Thermotherapy in Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03039127
• Other study ID #: CTP-2015-009
• Status: Terminated
• Phase: N/A
• Start date: June 2016
• Est. completion date: August 2018

Study information

• Verified date: July 2021
• Source: Clinical Laserthermia Systems AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Nottingham Breast Cancer Institute	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Laserthermia Systems AB	Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

Haraldsdóttir 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. — View Citation

Haraldsdóttir 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. — View Citation

Ivarsson K, Myllymäki 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. — View Citation

Ivarsson K, Myllymäki 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. — View Citation

Tranberg KG, Möller PH, Hannesson P, Stenram U. Interstitial laser treatment of malignant tumours: initial experience. Eur J Surg Oncol. 1996 Feb;22(1):47-54. — View Citation

Tranberg KG, Myllymäki L, Möller PH, Ivarsson K, Sjögren HO, Stenram U. Interstitial laser thermotherapy of a rat liver adenocarcinoma. J Xray Sci Technol. 2002 Jan 1;10(3):177-85. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment effect by radiology	Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)	9 months
Secondary	Safety (adverse events)	Evaluation of adverse events and laboratory analyses.	9 months
Secondary	Usability (user evaluation of instrument)	Analysis of instrument and user questionnaires relating to the ease of use.	9 months