Imaging Study with 89Zr-Bevacizumab for Predicting Treatment Effects in Patients with NF2-Related Schwannomatosis

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What is this study about?

This clinical trial is focused on studying a condition known as Neurofibromatosis Type 2 (NF2), which is a genetic disorder that causes tumors to grow on nerves, particularly affecting the nerves responsible for hearing. The study is specifically looking at a type of tumor called vestibular schwannomas, which can lead to hearing loss. The treatment being investigated is called 89Zr-Bevacizumab, which is a special form of a drug that is used to help visualize these tumors using a type of imaging called PET/CT scan. This imaging technique combines two methods: positron emission tomography (PET) and computed tomography (CT), to provide detailed pictures of the inside of the body.

The purpose of the study is to see if the 89Zr-Bevacizumab PET/CT scan can predict how well patients with NF2 will respond to treatment with Bevacizumab, a medication that is used to treat these tumors. During the study, participants will undergo the PET/CT scan before starting their treatment with Bevacizumab. The researchers will then monitor the participants to see if there is a correlation between the scan results and improvements in hearing or changes in the size of the tumors.

Throughout the study, the researchers will also look at other factors such as how the treatment affects the patients’ overall well-being, balance, and function of other nerves. The study aims to provide valuable information that could help improve the management of NF2 and potentially enhance the quality of life for those affected by this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of NF2-related schwannomatosis, and measurable disease through MRI scans.

Written informed consent is required before proceeding.

2 pre-treatment imaging

A PET/CT scan using 89Zr-Bevacizumab is performed. This imaging helps predict the response to future treatment.

The scan involves an intravenous injection of the tracer, which is a form of imaging that helps visualize the tumors.

3 treatment planning

Based on the imaging results, a treatment plan with bevacizumab is prepared. This plan is tailored to the individual’s condition and response predictions.

4 bevacizumab treatment

The treatment involves regular administration of bevacizumab. The dosage and frequency are determined by the healthcare provider based on the treatment plan.

The goal is to assess the hearing response and other outcomes as predicted by the initial imaging.

5 ongoing assessments

Throughout the treatment, regular assessments are conducted to monitor hearing, vestibular function, and other health parameters.

These assessments help evaluate the effectiveness of the treatment and adjust the plan if necessary.

6 final evaluation

At the end of the treatment period, a final evaluation is conducted to assess the overall response to the treatment.

This includes a review of hearing response, radiographic response, and any changes in other health parameters.

Who Can Join the Study?

Patients must be 18 years or older.
Must have a confirmed diagnosis of NF2, which is a specific medical condition, using certain criteria.
Must have provided written informed consent, meaning they agree to participate after understanding the study details.
Must have a measurable disease, which means having at least one vestibular schwannoma (a type of tumor) larger than 0.4 ml that can be measured using a special MRI scan.
Must be eligible and planned for bevacizumab treatment, which is a specific type of medication used in the study.

Who Cannot Join the Study?

Patients who do not have NF2-related schwannomatosis cannot participate. This is a specific condition involving nerve tumors.
Patients who are not within the specified age range cannot participate. The study includes both children and adults.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Lalun Uezbjtsgqppx Mgylksp Cnhjnpn (clxvm	Leiden	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.07.2022

Trial locations

Investigated drugs:

Bevacizumab Zirconium Zr-89

Bevacizumab is a medication used in this trial to treat patients with vestibular schwannomas, which are tumors associated with neurofibromatosis type 2. The trial aims to see if a special imaging technique can predict how well patients will respond to this treatment. Bevacizumab works by blocking a protein that helps tumors grow new blood vessels, which can slow down or stop the growth of the tumor.

Investigated diseases:

Neurofibromatosis

NF2-related schwannomatosis – This is a genetic disorder characterized by the development of non-cancerous tumors called schwannomas, primarily affecting the nervous system. These tumors commonly form on the vestibular nerves, which are responsible for balance and hearing, leading to symptoms such as hearing loss, balance issues, and tinnitus. The condition is caused by mutations in the NF2 gene, which normally helps control cell growth. As the disease progresses, additional schwannomas may develop on other nerves, potentially affecting other cranial nerves and spinal nerves. The growth of these tumors can lead to various neurological symptoms depending on their location. The progression of the disease varies among individuals, with some experiencing more severe symptoms than others.

Trial ID:

2024-512860-75-00

NCT ID:

NCT05685836

Trial Phase:

Therapeutic exploratory (Phase II)

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Imaging Study with 89Zr-Bevacizumab for Predicting Treatment Effects in Patients with NF2-Related Schwannomatosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?