Study on [18F]mFBG PET-CT Imaging for Patients with Pheochromocytoma

2 1 1

What is this study about?

This clinical trial is focused on studying a rare type of tumor called pheochromocytoma, which is an endocrine tumor that typically forms in the adrenal glands. The study will use a special imaging technique called [18F]mFBG PET-CT to help detect these tumors. The treatment involves an injection of a solution containing a substance known as M-(18F)-Fluorobenzylguanidine, also referred to as [18F]mFBG or Florbenguane (18F). This substance is designed to help highlight the tumors during the imaging process.

The purpose of the study is to compare the effectiveness of the [18F]mFBG PET-CT scan in detecting pheochromocytoma lesions against the conventional CT scan. Participants will undergo the [18F]mFBG PET-CT scan, and the results will be compared to their previous CT scans. The study aims to determine how many pheochromocytoma lesions can be detected using this new imaging method.

Throughout the study, researchers will also look at the best timing for the [18F]mFBG PET-CT scan by comparing images taken at different times. They will also examine how the scan results relate to the actual tumor characteristics and assess the safety of the [18F]mFBG injection by monitoring any side effects. The study is expected to continue until early 2027.

1 initial assessment

Upon joining the study, the patient undergoes an initial assessment to confirm eligibility. This includes reviewing the diagnosis of pheochromocytoma, an adrenal gland tumor, and ensuring a recent CT scan is available.

The patient must have a planned surgery and meet specific health criteria, such as being 18 years or older and having an ECOG status of Grade 0 to 2, which indicates the patient’s level of functioning.

2 preparation for imaging

The patient is prepared for the [18F]mFBG PET-CT scan. This involves understanding the procedure and any necessary preparations, such as fasting or avoiding certain medications, as advised by the medical team.

3 administration of [18F]mFBG

The patient receives an injection of [18F]mFBG, a radioactive tracer, through an intravenous route. This solution is used to highlight the tumor during the imaging process.

4 PET-CT imaging

The patient undergoes a PET-CT scan to detect pheochromocytoma lesions. The scan is performed at specific time points, typically 1 and 2 hours after the injection, to assess the optimal imaging time.

5 post-imaging analysis

The results of the PET-CT scan are analyzed to determine the number of lesions detected. This is compared to previous CT scans to evaluate the effectiveness of the [18F]mFBG in identifying tumors.

Additional analyses may include correlating PET findings with pathology and assessing the radiation dose received by normal tissues.

6 safety evaluation

The patient’s health is monitored for any adverse effects following the administration of [18F]mFBG. This includes evaluating any clinical symptoms that may arise.

7 follow-up

The patient may have follow-up appointments to discuss the results and any further steps in their treatment plan. This ensures ongoing monitoring and care.

Who Can Join the Study?

The patient must provide written informed consent before participating in the study. This means they agree to join the study after understanding what it involves.
The patient must be at least 18 years old at the time they give their consent.
The patient must have a diagnosis of pheochromocytoma, which is a type of tumor in the adrenal gland, or have test results that suggest pheochromocytoma, such as high levels of certain substances in the blood.
The patient should have surgery planned as part of their treatment.
The patient must have had a CT scan within the last 8 weeks before undergoing the [18F]mFBG PET-CT scan. A CT scan is an imaging test that helps doctors see inside the body.
The patient must have an ECOG status of Grade 0 to 2. ECOG status is a scale that measures how well a patient can perform daily activities. Grade 0 means fully active, and Grade 2 means the patient is up and about more than half of the day but may not be able to work.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.10.2021

Trial locations

[18F]mFBG is a special imaging agent used in PET-CT scans. It helps doctors see certain types of tumors called pheochromocytomas. This agent is injected into the body, and it lights up the tumors on the scan, making them easier to find and diagnose. The goal of using [18F]mFBG in this study is to see if it can detect more tumors than the usual CT scans.

Investigated diseases:

Phaeochromocytoma

Pheochromocytoma – Pheochromocytoma is a rare tumor that develops in the adrenal glands, which are located above the kidneys. These tumors can cause the adrenal glands to produce excess hormones, leading to symptoms such as high blood pressure, headaches, and sweating. The condition is often characterized by episodes of these symptoms, which can vary in frequency and intensity. Pheochromocytomas are usually benign, but they can sometimes be malignant. The progression of the disease involves the growth of the tumor, which may lead to increased hormone production and more pronounced symptoms. The condition is typically identified through imaging studies and confirmed by histological examination.

Trial ID:

2024-513622-35-00

Protocol code:

21-513

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on [18F]mFBG PET-CT Imaging for Patients with Pheochromocytoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?