LITT for Ultra-early GBM Recurrence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
Glioblastoma (GBM) remains aggressive despite standard therapy (surgery (CRET) + RT/CT). Over 40% of patients develop recurrence between surgery and pre-RT MRI, with median overall survival (OS) of 13.3m and 24.4m for patients with and without recurrence in pre-RT MRI, respectively. Reoperation is avoided as it delays adjuvant therapy.
LITT offers a minimally invasive alternative that may:
* Treat recurrence without delaying RT/CT * Potentially sensitize tumors to subsequent therapy This study tests if LITT can be practically integrated within the critical 1-week window between pre-RT MRI and radiotherapy initiation, maintaining the adjuvant schedule.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed glioblastoma, IDH-wildtype, regardless of MGMT status
≥18 years of age
CRET
Karnofsky Performance Status (KPS) ≥70
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
LITT
DevicePatients undergoing MR-guided Laser Interstitial Thermal Therapy (LITT) between pre-RT MRI and RT.
Treatment groups
12 Participants
are divided into 3 treatment groupsGroup A: LITT GroupExperimental treatment 1 intervention
Group B: Control Group 1 ("No recurrence")No intervention 0 interventions
Group C: Control Group 2 ("No LITT")No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Rate of patients who successfully complete the planned treatment
Proportion of CRET patients who successfully complete the planned treatment protocol without protocol violation, until the end of radiation therapy. A protocol violation is defined as any of the following: a delay of more than 7 days in the scheduled pre-RT MRI, LITT procedure, or RT initiation, or an interruption of RT due to a LITT-related event. The study teams aims to describe logistical and organizational difficulties (coordination of intraoperative MRI-availability, engineering support).
Time frame
from enrollment to the end of radiotherapy, an average of 8 weeksSecondary outcomes
1
Complications of LITT
Any deviation from the normal postoperative course, including any new appearance of blood during LITT MRI, any seeding along the trajectory of the probe, any pathological wound condition such as dehiscence or infection
Time frame
from enrollment to the end of radiotherapy, an average of 8 weeks2
Delay of Radiotherapy
Measurement of the time-lag between planning MRI and beginning of radiation, and comparsion to pre-planned radiation start
Time frame
assessed the day of radiation start, ranging from 3 to 6 weeks after GBM resection3
Use of steroids
Use of steroids: Binary (yes/no) and, if applicable, dose and duration
Time frame
from enrollment to the end of radiotherapy, an average of 8 weeks4
Evolution of radiation necrosis
Any increase of the size of the contrast enhancing lesion
Time frame
from enrollment to the end of radiotherapy, an average of 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov