89Zr-Bevacizumab PET/CT Imaging in NF2 Patients

Recruiting

• Conditions: Neurofibromatosis 2
• Interventions: Drug: Bevacizumab Zirconium Zr-89

• Registration Number: NCT05685836
• Lead Sponsor: Leiden University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-20
• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2023-01-05
• Study First Posted: 2023-01-17
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bevacizumab	Bevacizumab Zirconium Zr-89	After determining eligibility, all patients will undergo standard-of-care treatment with the sole addition of a pre-treatment 89Zr-Bevacizumab PET/CT-scan. Patients will first receive 5 mg 89Zr-Bevacizumab 4 days before PET/CT scan. This is followed by standard-of-care intravenous 7.5mg/kg bevacizumab (Avastin) therapy, administered every three weeks for six months

Primary Outcome Measures

Name	Time	Method
Hearing response (HR) - PTA	6 months	Pure Tone Average (PTA), in dB
Hearing response (HR) - WRS	6 months	Word Recognition Score (WRS), % at x dB
Radiographic response (RR) - tumor volumetry on MRI	6 months	Size change in volumetric MRI (REiNS criteria); volumetry in mL or mm
Radiographic response (RR) - ADC	6 months	Apparent diffusion coefficient (ADC) of tumor of interest, in mm2/s, on greatest diameter
Radiographic response (RR) - Microbleeds	6 months	Location and number of microbleeds
Radiographic response (RR) - Diffusion restriction	6 months	Diffusion restriction, yes / no

Secondary Outcome Measures

Name	Time	Method
Patient reported outcome measures (PROM)	6 months	Questionnaire on Quality of Life, and presence of symptoms
Physical examination	6 months	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.
Vestibular Function	6 months	Caloric test
Renal function	6 months	Creatinine clearance (mmol/L), eGFR (mL/minute)

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Zuid-Holland, Netherlands