Immunostimulating Interstitial Laser Thermotherapy in Breast Cancer
Raktažodžiai
Santrauka
Datos
Paskutinį kartą patikrinta: | 12/31/2018 |
Pirmasis pateikimas: | 06/28/2016 |
Numatytas registravimas pateiktas: | 01/29/2017 |
Pirmas paskelbtas: | 01/31/2017 |
Paskutinis atnaujinimas pateiktas: | 01/28/2019 |
Paskutinis atnaujinimas paskelbtas: | 01/29/2019 |
Faktinė studijų pradžios data: | 05/31/2016 |
Numatoma pirminio užbaigimo data: | 06/30/2018 |
Numatoma studijų užbaigimo data: | 07/31/2018 |
Būklė ar liga
Intervencija / gydymas
Device: imILT
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
Experimental: imILT Immunostimulating Interstitial Laser Thermotherapy (imILT) | Device: imILT 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. |
Tinkamumo kriterijai
Tinkamos studijoms lytys | All |
Priima sveikus savanorius | Taip |
Kriterijai | 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. |
Rezultatas
Pirminės rezultatų priemonės
1. Treatment effect by radiology [9 months]
Antrinės rezultatų priemonės
1. Safety (adverse events) [9 months]
2. Usability (user evaluation of instrument) [9 months]