Immunostimulating Interstitial Laser Thermotherapy in Breast Cancer
NCT ID: NCT03039127
Last Updated: 2021-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2016-06-30
2018-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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imILT
Immunostimulating Interstitial Laser Thermotherapy (imILT)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
2. Have active autoimmune disease
3. Are on corticosteroid medication
4. Have evidence of bleeding diathesis or coagulopathy.
ALL
No
Sponsors
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Nottingham University Hospitals NHS Trust
OTHER
Clinical Laserthermia Systems AB
INDUSTRY
Responsible Party
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Principal Investigators
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Kristjan S Asgeirsson, MD
Role: PRINCIPAL_INVESTIGATOR
Nottingham Breast Institute
Locations
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Nottingham Breast Cancer Institute
Nottingham, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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CTP-2015-009
Identifier Type: -
Identifier Source: org_study_id
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