Breast NeoplasmsNCT03039127
Immunostimulating Interstitial Laser Thermotherapy in Breast Cancer
A study testing Immunostimulating Interstitial Laser Thermotherapy in people with Breast Neoplasms, run by Clinical Laserthermia Systems AB at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Immunostimulating Interstitial Laser Thermotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Are known to be HIV positive
- Have active autoimmune disease
- Are on corticosteroid medication
- Have evidence of bleeding diathesis or coagulopathy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham Breast Cancer Institute
Nottingham, NG5 1PB
About this study
Official title: Interstitial Laser Thermotherapy (imILT) as a Treatment Option in Breast Cancer Patients Not Suitable for Surgical Excision
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.
Read more
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.
- Conditions
- Breast Neoplasms
- Being tested
- Immunostimulating Interstitial Laser Thermotherapy
- Keywords
- Hyperthermia, Laser Coagulation, Laser Therapy, Induced
- Medical subject headings
- Breast Neoplasms, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunostimulating Interstitial Laser ThermotherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| imILT | Experimental | Immunostimulating Interstitial Laser Thermotherapy (imILT) Receives: Device: Immunostimulating Interstitial Laser Thermotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment effect by radiology
Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)
Measured: 9 months
Secondary outcomes (2)
Safety (adverse events)
Evaluation of adverse events and laboratory analyses.
Measured: 9 months
Usability (user evaluation of instrument)
Analysis of instrument and user questionnaires relating to the ease of use.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study startJun 2016
- Primary completionJul 2018
- Study completionAug 2018
Why it stopped: Study was stopped in agreement with investigator due to slow recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Laserthermia Systems AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Kristjan S Asgeirsson, MD, Principal investigator, Nottingham Breast Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039127
- Sponsor's protocol ID
- CTP-2015-009
- Status last verified
- Jul 2021
- First submitted
- 29 Jun 2016
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26504041Haraldsdottir 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.
PubMed 21400025Ivarsson 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.
PubMed 16091763Tranberg 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.
PubMed 8846867Tranberg 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.
PubMed 22388047Ivarsson 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.
PubMed 14666667
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial Laser Thermotherapy (imILT) as a Treatment Option in Breast Cancer Patients Not Suitable for Surgical Excision
- ClinicalTrials.gov ID
- NCT03039127
- Acronym / sponsor ID
- CTP-2015-009
- Conditions
- Breast Neoplasms
- Keywords
- Hyperthermia, Laser Coagulation, Laser Therapy, Induced
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped in agreement with investigator due to slow recruitment.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Clinical Laserthermia Systems ABIndustry (pharma, biotech, devices)
- Collaborators
- Nottingham University Hospitals NHS Trust
- Study start
- Jun 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| imILT | Experimental | Device: Immunostimulating Interstitial Laser ThermotherapyImmunostimulating Interstitial Laser Thermotherapy (imILT) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Are known to be HIV positive
- Have active autoimmune disease
- Are on corticosteroid medication
- Have evidence of bleeding diathesis or coagulopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunostimulating Interstitial Laser ThermotherapyImmunostimulating 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. | Device | imILT |
Primary outcome
Treatment effect by radiology
Time frame: 9 months
Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)
2 secondary outcomes
Safety (adverse events)
Time frame: 9 months
Usability (user evaluation of instrument)
Time frame: 9 months
Results and safety
The study was stopped early (reason given: Study was stopped in agreement with investigator due to slow recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Results publication: PubMed 26504041Haraldsdottir 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 publication: PubMed 21400025Haraldsdottir 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 publication: PubMed 16091763Ivarsson 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 publication: PubMed 8846867Tranberg 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 publication: PubMed 22388047Tranberg 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 publication: PubMed 14666667Ivarsson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristjan S Asgeirsson, MD principal investigator
Nottingham Breast Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunostimulating Interstitial Laser Thermotherapy in people with Breast Neoplasms, run by Clinical Laserthermia Systems AB at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was stopped in agreement with investigator due to slow recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment effect by radiology (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03039127, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.