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.
Study Type
OBSERVATIONAL
Enrollment
15
See Arm description.
Leiden University Medical Center
Leiden, South Holland, Netherlands
RECRUITINGHearing response (HR) - WRS
Word Recognition Score (WRS), % at x dB
Time frame: Baseline
Hearing response (HR) - WRS
Word Recognition Score (WRS), % at x dB
Time frame: 3 months
Hearing response (HR) - WRS
Word Recognition Score (WRS), % at x dB
Time frame: 6 months
Hearing response (HR) - PTA
Pure Tone Average (PTA), in dB
Time frame: Baseline
Hearing response (HR) - PTA
Pure Tone Average (PTA), in dB
Time frame: 3 months
Hearing response (HR) - PTA
Pure Tone Average (PTA), in dB
Time frame: 6 months
Radiographic response (RR) - tumor volumetry on MRI
Size change in volumetric MRI (REiNS criteria); volumetry in mL or mm
Time frame: Baseline
Radiographic response (RR) - tumor volumetry on MRI
Size change in volumetric MRI (REiNS criteria); volumetry in mL or mm
Time frame: 3 months
Radiographic response (RR) - tumor volumetry on MRI
Size change in volumetric MRI (REiNS criteria); volumetry in mL or mm
Time frame: 6 months
Radiographic response (RR) - ADC
Apparent diffusion coefficient (ADC) of tumor of interest, in mm2/s, on greatest diameter
Time frame: Baseline
Radiographic response (RR) - ADC
Apparent diffusion coefficient (ADC) of tumor of interest, in mm2/s, on greatest diameter
Time frame: 3 months
Radiographic response (RR) - ADC
Apparent diffusion coefficient (ADC) of tumor of interest, in mm2/s, on greatest diameter
Time frame: 6 months
Radiographic response (RR) - Microbleeds
Location and number of microbleeds
Time frame: Baseline
Radiographic response (RR) - Microbleeds
Location and number of microbleeds
Time frame: 3 months
Radiographic response (RR) - Microbleeds
Location and number of microbleeds
Time frame: 6 months
Radiographic response (RR) - Diffusion restriction
Diffusion restriction, yes / no
Time frame: Baseline
Radiographic response (RR) - Diffusion restriction
Diffusion restriction, yes / no
Time frame: 3 months
Radiographic response (RR) - Diffusion restriction
Diffusion restriction, yes / no
Time frame: 6 months
Vestibular Function
Video-Head Impulse Test (vHIT)
Time frame: Baseline
Vestibular Function
Video-Head Impulse Test (vHIT)
Time frame: 3 months
Vestibular Function
Video-Head Impulse Test (vHIT)
Time frame: 6 months
Vestibular Function
cervical Vestibular Evoked Myogenic Potential (cVEMP) test
Time frame: Baseline
Vestibular Function
cervical Vestibular Evoked Myogenic Potential (cVEMP) test
Time frame: 3 months
Vestibular Function
cervical Vestibular Evoked Myogenic Potential (cVEMP) test
Time frame: 6 months
Vestibular Function
Caloric test
Time frame: Baseline
Vestibular Function
Caloric test
Time frame: 3 months
Vestibular Function
Caloric test
Time frame: 6 months
Patient reported outcome measures (PROM)
Questionnaire on Quality of Life, and presence of symptoms
Time frame: Baseline
Patient reported outcome measures (PROM)
Questionnaire on Quality of Life, and presence of symptoms
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Time frame: 3 months
Patient reported outcome measures (PROM)
Questionnaire on Quality of Life, and presence of symptoms
Time frame: 6 months
Physical examination
General neurological examination is performed to assess if the patient has neurological symptoms, if any. The examination is done according to standard clinical care and has a descriptive nature. Cranial nerve (dys)function, including House Brackmann scale for the facial nerve (n. VII) and trigeminal nerve function (n. V), including presence of neuralgia and hypoesthesia, are described in more detail.
Time frame: Baseline
Physical examination
General neurological examination is performed to assess if the patient has neurological symptoms, if any. The examination is done according to standard clinical care and has a descriptive nature. Cranial nerve (dys)function, including House Brackmann scale for the facial nerve (n. VII) and trigeminal nerve function (n. V), including presence of neuralgia and hypoesthesia, are described in more detail.
Time frame: 3 months
Physical examination
General neurological examination is performed to assess if the patient has neurological symptoms, if any. The examination is done according to standard clinical care and has a descriptive nature. Cranial nerve (dys)function, including House Brackmann scale for the facial nerve (n. VII) and trigeminal nerve function (n. V), including presence of neuralgia and hypoesthesia, are described in more detail.
Time frame: 6 months
Renal function
Creatinine clearance (CrCl), eGFR (mL/minute, ref. \>90)
Time frame: Baseline
Renal function
Creatinine clearance (mmol/L), eGFR (mL/minute)
Time frame: 3 months
Renal function
Creatinine clearance (mmol/L), eGFR (mL/minute)
Time frame: 6 months