Clinical trial NCT05685836: 89Zr-Bevacizumab PET/CT Imaging in NF2 Patients
Official title: 89Zr-Bevacizumab PET/CT Imaging of Vestibular Schwannomas for the Prediction of Bevacizumab Treatment Effect in Patients With Symptomatic Neurofibromatosis Type 2
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurofibromatosis 2
Keywords: neurofibromatosis 2
NF2-related schwannomatosis
vestibular schwannoma
bevacizumab
89Zr-Bevacizumab
PET/CT imaging
hearing
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a confirmed diagnosis of NF2 and candidate for bevacizumab therapy.

Brief summary: Bevacizumab can be an effective treatment for individuals with NF2 and improve different nerve functions (like hearing, tinnitus or balance problems) and the quality of life of NF2 patients. However, bevacizumab is not effective in all patients or all tumors, at the cost of moderate toxicity and considerable financial burden.

Therefore, this observational study will validate an imaging biomarker method to predict bevacizumab efficacy in order to avoid adverse effects and high costs in non-responders to bevacizumab treatment. Patients will undergo standard-of-care treatment with the sole addition of a pre-treatment 89Zr-Bevacizumab PET/CT-scan. Per standard-of-care bevacizumab therapy is administered every three weeks for six months. To monitor treatment effect, follow-up is performed at 3-month intervals.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older
* Confirmed diagnosis of NF2 by revised Manchester criteria
* Provided written informed consent
* Patients must have measurable disease, defined as at least one VS \> 0.4 ml (on volumetric analysis) that can be accurately measured by contrast-enhanced T1-weighted cranial MRI scan.
* Eligible and planned for bevacizumab treatment

Exclusion Criteria:

* Patients with a contra-indication for PET and MRI, such as pregnancy and metal elements.
* Patients with a known allergy to substances used in this study
* Concurrent treatment with Everolimus

Primary outcomes:
measure: Hearing response (HR) - WRS
timeFrame: Baseline
measure: Hearing response (HR) - WRS
timeFrame: 3 months
measure: Hearing response (HR) - WRS
timeFrame: 6 months
measure: Hearing response (HR) - PTA
timeFrame: Baseline
measure: Hearing response (HR) - PTA
timeFrame: 3 months
measure: Hearing response (HR) - PTA
timeFrame: 6 months
measure: Radiographic response (RR) - tumor volumetry on MRI
timeFrame: Baseline
measure: Radiographic response (RR) - tumor volumetry on MRI
timeFrame: 3 months
measure: Radiographic response (RR) - tumor volumetry on MRI
timeFrame: 6 months
measure: Radiographic response (RR) - ADC
timeFrame: Baseline
measure: Radiographic response (RR) - ADC
timeFrame: 3 months
measure: Radiographic response (RR) - ADC
timeFrame: 6 months
measure: Radiographic response (RR) - Microbleeds
timeFrame: Baseline
measure: Radiographic response (RR) - Microbleeds
timeFrame: 3 months
measure: Radiographic response (RR) - Microbleeds
timeFrame: 6 months
measure: Radiographic response (RR) - Diffusion restriction
timeFrame: Baseline
measure: Radiographic response (RR) - Diffusion restriction
timeFrame: 3 months
measure: Radiographic response (RR) - Diffusion restriction
timeFrame: 6 months
Secondary outcomes:
measure: Vestibular Function
timeFrame: Baseline
measure: Vestibular Function
timeFrame: 3 months
measure: Vestibular Function
timeFrame: 6 months
measure: Vestibular Function
timeFrame: Baseline
measure: Vestibular Function
timeFrame: 3 months
measure: Vestibular Function
timeFrame: 6 months
measure: Vestibular Function
timeFrame: Baseline
measure: Vestibular Function
timeFrame: 3 months
measure: Vestibular Function
timeFrame: 6 months
measure: Patient reported outcome measures (PROM)
timeFrame: Baseline
measure: Patient reported outcome measures (PROM)
timeFrame: 3 months
measure: Patient reported outcome measures (PROM)
timeFrame: 6 months
measure: Physical examination
timeFrame: Baseline
measure: Physical examination
timeFrame: 3 months
measure: Physical examination
timeFrame: 6 months
measure: Renal function
timeFrame: Baseline
measure: Renal function
timeFrame: 3 months
measure: Renal function
timeFrame: 6 months
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
affiliation: Leiden University Medical Center
name: Hans AJ Gelderblom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: