NCT05296122Completed
Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions
Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesion Using the Tranberg® Thermal Therapy System and Tranberg® Thermoguide Workstation
Source: ClinicalTrials.gov · Last updated 15 Jan 2025
Brief summary (registry, in English)
This will be an open-label, pilot, exploratory, single centre clinical investigation. This is an early feasibility single arm study. No formal hypothesis is proposed. A total of up to 15 evaluable subjects receiving a non-radical ablation is planned. The safety and feasibility outcomes will be measured directly post-treatment, 48h and 3 months post-treatment. A minimal invasive neurosurgical approach with a Magnetic Resonance Imaging (MRI)-based stereotactic guidance system will be utilized for the planning, navigation, intracranial access, placement and confirmation of the Laser applicator prior to ablation.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 15 Feb 2022
- Start date
- 12 May 2022
- Primary completion date
- 30 Aug 2024
- Lead sponsor
- Clinical Laserthermia Systems AB
- Diseases
- Glioblastoma
- NCT number
- NCT05296122
What you commit to
- Study type: Interventional
- Participants enrolled: 14
- From 12 May 2022 to the primary completion date, 30 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous (within 30 days prior to enrollment / randomization) and concurrent treatment during the treatment phase with other investigational drug/s or device/s
Other illness
- Known bleeding disorder
- Any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation
Lab values
- Subject evaluated not to be fit for surgery due to liver/kidney/other organ dysfunction verified by laboratory tests
Other
- Subject contraindicated for MRI, including subjects who may have contraindications due to implanted medical devices
- Identified intratumoral cystic or haemorrhagic transformation in target tumor
- ECOG performance status of \>2
- Pregnancy or breastfeeding
- The subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation
- The subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason.
Who the study is looking for
- Lesions eligible for Laser Interstitial ThermoTherapy (LITT), target tumor ≤10cc in volume
- Age ≥ 18 and \< 80 years
- Ability to undergo contrast-enhanced Computed Tomography (CT), Positron Emission Tomography (PET)-CT and contrast-enhanced MRI.
- Women of childbearing potential must have a negative pregnancy test.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
- Primary glioblastoma/astrocytoma WHO grade IV confirmed by 1)Magnetic Resonance Imaging according to RANO citera and 2)Frozen section biosy diagnosis, and considered not suitable for open surgery or other primary treatment, or Recurrent glioblastoma/astrocytoma WHO grade IV confirmed by Magnetic Resonance Imaging according to RANO criteria.
- ≥3 months since last radiotherapy of the brain
- Supratentorial tumor localization with or without prior surgery for recurrence.
- Life expectancy of ≥3 months
- The subject reports having understood and has signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments.
- Anticipated compliance with treatment and follow-up
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurosurgery, Skane University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.