Immunostimulating Interstitial Laser Thermotherapy in Solid Cancers
Raktažodžiai
Santrauka
Datos
Paskutinį kartą patikrinta: | 12/31/2018 |
Pirmasis pateikimas: | 02/14/2016 |
Numatytas registravimas pateiktas: | 02/18/2016 |
Pirmas paskelbtas: | 02/23/2016 |
Paskutinis atnaujinimas pateiktas: | 01/28/2019 |
Paskutinis atnaujinimas paskelbtas: | 01/29/2019 |
Faktinė studijų pradžios data: | 01/31/2016 |
Numatoma pirminio užbaigimo data: | 03/31/2018 |
Numatoma studijų užbaigimo data: | 03/31/2018 |
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
Amžius, tinkami studijuoti | 18 Years Į 18 Years |
Tinkamos studijoms lytys | All |
Priima sveikus savanorius | Taip |
Kriterijai | Inclusion Criteria: - Are male or female > 18 years of age - Have histologically confirmed, locally uncontrolled, solid cancer, with or without metastases, that cannot be treated surgically due to unresectability or inoperability - Have one or more tumours assessable by MRI/CT or ultrasound and situated in such a way that at least a part of the tumour can be treated with IMILT without damage to surrounding vital structures or the skin - Are candidates for ablative intervention also outside this study - Have given informed verbal and written consent to participation in the trial - Have an ECOG performance status < 2 (Karnofsky > 60%) - Have stable haematologic, renal and hepatic functions Exclusion Criteria: - Are HIV positive - Have an active autoimmune disease - Are on systemic corticosteroid medication (local treatment with aerosol's and ointment is allowed) - Have known bleeding disorders or are treated with anticoagulant medication - Are pregnant or nursing |
Rezultatas
Pirminės rezultatų priemonės
1. Treatment effect (Measurement of tumor burden by irRC criteria) [18 months]
Antrinės rezultatų priemonės
1. Inflammatory response in tumor measured by quantification of inflammatory cell populations [18 months]
2. Inflammatory response in circulation measured by quantification of inflammatory cell populations [18 months]
3. Safety (adverse events) [18 months]
4. Evaluation of pain (measured by VAS) [18 months]
5. Evaluation of Quality of Life (using a standardized questionnaire) [18 months]
6. Usability of the device as evaluated by treatment logs [18 months]