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89Zr-Bevacizumab PET/CT Imaging in NF2 Patients

Sponsor
Leiden University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05685836
Collaborator
(none)
15
Enrollment
1
Location
20.4
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bevacizumab Zirconium Zr-89

Study Design

Study Type:
Observational
Anticipated Enrollment :
15 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
89Zr-Bevacizumab PET/CT Imaging of Vestibular Schwannomas for the Prediction of Bevacizumab Treatment Effect in Patients With Symptomatic Neurofibromatosis Type 2
Actual Study Start Date :
Oct 20, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Bevacizumab

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hearing response (HR) - WRS [Baseline]

      Word Recognition Score (WRS), % at x dB

    2. Hearing response (HR) - WRS [3 months]

      Word Recognition Score (WRS), % at x dB

    3. Hearing response (HR) - WRS [6 months]

      Word Recognition Score (WRS), % at x dB

    4. Hearing response (HR) - PTA [Baseline]

      Pure Tone Average (PTA), in dB

    5. Hearing response (HR) - PTA [3 months]

      Pure Tone Average (PTA), in dB

    6. Hearing response (HR) - PTA [6 months]

      Pure Tone Average (PTA), in dB

    7. Radiographic response (RR) - tumor volumetry on MRI [Baseline]

      Size change in volumetric MRI (REiNS criteria); volumetry in mL or mm

    8. Radiographic response (RR) - tumor volumetry on MRI [3 months]

      Size change in volumetric MRI (REiNS criteria); volumetry in mL or mm

    9. Radiographic response (RR) - tumor volumetry on MRI [6 months]

      Size change in volumetric MRI (REiNS criteria); volumetry in mL or mm

    10. Radiographic response (RR) - ADC [Baseline]

      Apparent diffusion coefficient (ADC) of tumor of interest, in mm2/s, on greatest diameter

    11. Radiographic response (RR) - ADC [3 months]

      Apparent diffusion coefficient (ADC) of tumor of interest, in mm2/s, on greatest diameter

    12. Radiographic response (RR) - ADC [6 months]

      Apparent diffusion coefficient (ADC) of tumor of interest, in mm2/s, on greatest diameter

    13. Radiographic response (RR) - Microbleeds [Baseline]

      Location and number of microbleeds

    14. Radiographic response (RR) - Microbleeds [3 months]

      Location and number of microbleeds

    15. Radiographic response (RR) - Microbleeds [6 months]

      Location and number of microbleeds

    16. Radiographic response (RR) - Diffusion restriction [Baseline]

      Diffusion restriction, yes / no

    17. Radiographic response (RR) - Diffusion restriction [3 months]

      Diffusion restriction, yes / no

    18. Radiographic response (RR) - Diffusion restriction [6 months]

      Diffusion restriction, yes / no

    Secondary Outcome Measures

    1. Vestibular Function [Baseline]

      Video-Head Impulse Test (vHIT)

    2. Vestibular Function [3 months]

      Video-Head Impulse Test (vHIT)

    3. Vestibular Function [6 months]

      Video-Head Impulse Test (vHIT)

    4. Vestibular Function [Baseline]

      cervical Vestibular Evoked Myogenic Potential (cVEMP) test

    5. Vestibular Function [3 months]

      cervical Vestibular Evoked Myogenic Potential (cVEMP) test

    6. Vestibular Function [6 months]

      cervical Vestibular Evoked Myogenic Potential (cVEMP) test

    7. Vestibular Function [Baseline]

      Caloric test

    8. Vestibular Function [3 months]

      Caloric test

    9. Vestibular Function [6 months]

      Caloric test

    10. Patient reported outcome measures (PROM) [Baseline]

      Questionnaire on Quality of Life, and presence of symptoms

    11. Patient reported outcome measures (PROM) [3 months]

      Questionnaire on Quality of Life, and presence of symptoms

    12. Patient reported outcome measures (PROM) [6 months]

      Questionnaire on Quality of Life, and presence of symptoms

    13. Physical examination [Baseline]

      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.

    14. Physical examination [3 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.

    15. 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.

    16. Renal function [Baseline]

      Creatinine clearance (CrCl), eGFR (mL/minute, ref. >90)

    17. Renal function [3 months]

      Creatinine clearance (mmol/L), eGFR (mL/minute)

    18. Renal function [6 months]

      Creatinine clearance (mmol/L), eGFR (mL/minute)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Leiden University Medical Center Leiden Zuid-Holland Netherlands 2333ZA

    Sponsors and Collaborators

    • Leiden University Medical Center

    Investigators

    • Principal Investigator: Hans AJ Gelderblom, MD, PhD, Leiden University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hans Gelderblom, Prof. A.J. Gelderblom, MD, PhD, Head of Medical Oncology, Principal Investigator, Leiden University Medical Center
    ClinicalTrials.gov Identifier:
    NCT05685836
    Other Study ID Numbers:
    • NF2PET
    • 2020-000156-35
    First Posted:
    Jan 17, 2023
    Last Update Posted:
    Jan 17, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Hans Gelderblom, Prof. A.J. Gelderblom, MD, PhD, Head of Medical Oncology, Principal Investigator, Leiden University Medical Center
    neurofibromatosis 2
    NF2-related schwannomatosis
    vestibular schwannoma
    bevacizumab
    89Zr-Bevacizumab
    PET/CT imaging
    hearing
    Additional relevant MeSH terms:
    Neurofibromatoses
    Neurofibromatosis 1
    Neurofibroma
    Neurofibromatosis 2
    Bevacizumab
    89Zr-bevacizumab

    Study Results

    No Results Posted as of Jan 17, 2023