Clinical trial · Interventional
Immunostimulating Interstitial Laser Thermotherapy in Breast Cancer
Interstitial Laser Thermotherapy (imILT) as a Treatment Option in Breast Cancer Patients Not Suitable for Surgical Excision
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was stopped in agreement with investigator due to slow recruitment.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunostimulating Interstitial Laser Thermotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- imILT
- description
- Immunostimulating Interstitial Laser Thermotherapy (imILT)
- interventionNames
- Device: Immunostimulating Interstitial Laser Thermotherapy
Primary outcomes (1)
- measure
- Treatment effect by radiology
- timeFrame
- 9 months
- description
- Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)
Secondary outcomes (2)
- measure
- Safety (adverse events)
- timeFrame
- 9 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (6)
- RESULTHaraldsdottir 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. PMID 26504041
- RESULTHaraldsdottir 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. PMID 21400025
- RESULTIvarsson 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. PMID 16091763
- RESULTTranberg 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. PMID 8846867
- RESULTTranberg 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. PMID 22388047
- RESULTIvarsson 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. PMID 14666667