89Zr-Bevacizumab PET/CT Imaging in NF2 Patients

Neurofibromatosis 2 Clinical Trial

Official title:

89Zr-Bevacizumab PET/CT Imaging of Vestibular Schwannomas for the Prediction of Bevacizumab Treatment Effect in Patients With Symptomatic Neurofibromatosis Type 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05685836
• Other study ID #: NF2PET
• Secondary ID: 2020-000156-35
• Status: Recruiting
• Start date: October 20, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Leiden University Medical Center
• Contact: Jules PJ Douwes, MD
• Phone: 715269111
• Email: j.p.j.douwes[@]lumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 1
• Neurofibromatosis 2

Intervention

Drug:
• Bevacizumab Zirconium Zr-89
See Arm description.

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hearing response (HR) - WRS	Word Recognition Score (WRS), % at x dB	Baseline
Primary	Hearing response (HR) - WRS	Word Recognition Score (WRS), % at x dB	3 months
Primary	Hearing response (HR) - WRS	Word Recognition Score (WRS), % at x dB	6 months
Primary	Hearing response (HR) - PTA	Pure Tone Average (PTA), in dB	Baseline
Primary	Hearing response (HR) - PTA	Pure Tone Average (PTA), in dB	3 months
Primary	Hearing response (HR) - PTA	Pure Tone Average (PTA), in dB	6 months
Primary	Radiographic response (RR) - tumor volumetry on MRI	Size change in volumetric MRI (REiNS criteria); volumetry in mL or mm	Baseline
Primary	Radiographic response (RR) - tumor volumetry on MRI	Size change in volumetric MRI (REiNS criteria); volumetry in mL or mm	3 months
Primary	Radiographic response (RR) - tumor volumetry on MRI	Size change in volumetric MRI (REiNS criteria); volumetry in mL or mm	6 months
Primary	Radiographic response (RR) - ADC	Apparent diffusion coefficient (ADC) of tumor of interest, in mm2/s, on greatest diameter	Baseline
Primary	Radiographic response (RR) - ADC	Apparent diffusion coefficient (ADC) of tumor of interest, in mm2/s, on greatest diameter	3 months
Primary	Radiographic response (RR) - ADC	Apparent diffusion coefficient (ADC) of tumor of interest, in mm2/s, on greatest diameter	6 months
Primary	Radiographic response (RR) - Microbleeds	Location and number of microbleeds	Baseline
Primary	Radiographic response (RR) - Microbleeds	Location and number of microbleeds	3 months
Primary	Radiographic response (RR) - Microbleeds	Location and number of microbleeds	6 months
Primary	Radiographic response (RR) - Diffusion restriction	Diffusion restriction, yes / no	Baseline
Primary	Radiographic response (RR) - Diffusion restriction	Diffusion restriction, yes / no	3 months
Primary	Radiographic response (RR) - Diffusion restriction	Diffusion restriction, yes / no	6 months
Secondary	Vestibular Function	Video-Head Impulse Test (vHIT)	Baseline
Secondary	Vestibular Function	Video-Head Impulse Test (vHIT)	3 months
Secondary	Vestibular Function	Video-Head Impulse Test (vHIT)	6 months
Secondary	Vestibular Function	cervical Vestibular Evoked Myogenic Potential (cVEMP) test	Baseline
Secondary	Vestibular Function	cervical Vestibular Evoked Myogenic Potential (cVEMP) test	3 months
Secondary	Vestibular Function	cervical Vestibular Evoked Myogenic Potential (cVEMP) test	6 months
Secondary	Vestibular Function	Caloric test	Baseline
Secondary	Vestibular Function	Caloric test	3 months
Secondary	Vestibular Function	Caloric test	6 months
Secondary	Patient reported outcome measures (PROM)	Questionnaire on Quality of Life, and presence of symptoms	Baseline
Secondary	Patient reported outcome measures (PROM)	Questionnaire on Quality of Life, and presence of symptoms	3 months
Secondary	Patient reported outcome measures (PROM)	Questionnaire on Quality of Life, and presence of symptoms	6 months
Secondary	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.	Baseline
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	Renal function	Creatinine clearance (CrCl), eGFR (mL/minute, ref. >90)	Baseline
Secondary	Renal function	Creatinine clearance (mmol/L), eGFR (mL/minute)	3 months
Secondary	Renal function	Creatinine clearance (mmol/L), eGFR (mL/minute)	6 months