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M-(18F)-Fluorobenzylguanidine

This article discusses ongoing clinical trials investigating the use of M-(18F)-Fluorobenzylguanidine ([18F]mFBG) in PET-CT imaging for patients with pheochromocytoma, a rare type of adrenal gland tumor. The trials aim to assess the effectiveness of this innovative imaging technique in detecting pheochromocytoma lesions compared to conventional CT scans, as well as evaluate its safety and optimal timing for imaging.

Table of Contents

What is M-(18F)-FLUOROBENZYLGUANIDINE?

M-(18F)-FLUOROBENZYLGUANIDINE, also known as [18F]mFBG, is a new imaging agent being studied for its potential in detecting and visualizing a rare type of tumor called pheochromocytoma[1]. This compound is a solution for injection and is being developed to improve the way doctors can see and diagnose these tumors using a special type of scan called PET-CT (Positron Emission Tomography-Computed Tomography).

The drug is also known by several other names, including:

  • [18F]meta-fluorobenzylguanidine
  • [18F]mFBG
  • Florbenguane (18F)
  • IRP-101

Understanding Pheochromocytoma

Pheochromocytoma is a rare type of tumor that develops in the adrenal glands, which are small glands located on top of your kidneys[1]. These tumors can produce excess hormones called catecholamines, which can cause high blood pressure, rapid heartbeat, and other symptoms. Accurate diagnosis and localization of these tumors are crucial for proper treatment.

How M-(18F)-FLUOROBENZYLGUANIDINE Works

M-(18F)-FLUOROBENZYLGUANIDINE is designed to be injected into the patient’s bloodstream. Once in the body, it travels to areas where pheochromocytoma tumors might be present. The compound is specially crafted to be taken up by these tumor cells[1].

When the patient undergoes a PET-CT scan, the M-(18F)-FLUOROBENZYLGUANIDINE lights up in areas where the tumors are located, allowing doctors to see them more clearly than with conventional CT scans alone. This could potentially lead to more accurate diagnosis and better treatment planning.

Current Clinical Trial

A clinical trial is currently underway to study the effectiveness of M-(18F)-FLUOROBENZYLGUANIDINE in imaging pheochromocytoma[1]. The main goal of this study is to compare how well [18F]mFBG PET-CT can detect pheochromocytoma lesions compared to conventional CT scans.

The study aims to answer several important questions:

  1. How many tumor lesions can [18F]mFBG PET-CT detect compared to regular CT scans?
  2. What is the best timing for taking the [18F]mFBG PET-CT images after injection?
  3. How well do the PET-CT findings match up with what doctors see when they examine the tumor tissue under a microscope?
  4. How much radiation does the body absorb from [18F]mFBG?
  5. Is [18F]mFBG safe to use in patients?

Potential Benefits of M-(18F)-FLUOROBENZYLGUANIDINE

If successful, M-(18F)-FLUOROBENZYLGUANIDINE could offer several benefits for patients with pheochromocytoma[1]:

  • More accurate detection of tumor lesions, potentially catching tumors that might be missed by conventional CT scans
  • Better understanding of the extent of the disease, which could help in planning surgery or other treatments
  • Improved ability to monitor the disease over time
  • Potential for earlier diagnosis, which could lead to better outcomes for patients

Safety Considerations

As with any new medical treatment or diagnostic tool, safety is a top priority. The clinical trial is designed to carefully monitor any side effects or adverse events that might occur after administration of M-(18F)-FLUOROBENZYLGUANIDINE[1]. The researchers will be looking closely at how patients react to the injection and if there are any unexpected effects.

It’s important to note that this compound contains a small amount of radioactive material (the “18F” part of the name), which is necessary for the PET-CT imaging to work. The study will measure how much radiation patients are exposed to, to ensure it stays within safe limits.

Who Can Participate in the Study?

The study has specific criteria for who can participate[1]. These include:

  • Patients who are 18 years or older
  • Patients diagnosed with pheochromocytoma or have lab results suggesting they might have it
  • Patients who are scheduled for surgery to remove the tumor
  • Patients who have had a CT scan within the last 8 weeks
  • Patients who are in relatively good overall health (ECOG status of 0-2, which means they are able to carry out most daily activities)

Some factors that would prevent a person from participating include:

  • Being pregnant or breastfeeding
  • Having active, serious infections not controlled by antibiotics
  • Being unable or unwilling to undergo PET-CT scanning or surgery
  • Having received treatment that might interfere with the study between the conventional CT scan and the [18F]mFBG PET-CT

This clinical trial represents an important step in improving how we diagnose and understand pheochromocytoma. If successful, M-(18F)-FLUOROBENZYLGUANIDINE could become a valuable tool in the fight against this rare but serious condition.

Aspect Details
Drug Name M-(18F)-Fluorobenzylguanidine ([18F]mFBG)
Administration Intravenous injection, maximum 2 MBq/kg
Target Condition Pheochromocytoma (adrenal gland tumor)
Primary Objective Compare lesion detection by [18F]mFBG PET-CT vs. conventional CT
Secondary Objectives Optimal imaging time, correlation with pathology, radiation dose estimation, safety analysis
Key Inclusion Criteria Age ≥18, diagnosed/suspected pheochromocytoma, planned surgery, recent CT scan
Key Exclusion Criteria Pregnancy, lactation, uncontrolled infections, inability to undergo PET-CT or surgery

FAQ

  • What is the main purpose of the clinical trial using [18F]mFBG? The main purpose is to assess how many pheochromocytoma lesions can be detected using [18F]mFBG PET-CT imaging compared to conventional CT scans. The lesions detected will be confirmed by histology (examination of tissue samples).
  • Who can participate in this clinical trial? Participants must be 18 years or older, have a diagnosis of pheochromocytoma or suspicious laboratory findings, be scheduled for surgery, have had a recent CT scan, and have an ECOG status of Grade 0-2. They must also provide written informed consent.
  • How is [18F]mFBG administered in the trial? The [18F]mFBG is administered as a solution for injection, given intravenously (into a vein). The maximum daily dose is 2 MBq/kg (megabecquerels per kilogram of body weight).
  • What are some of the secondary objectives of the trial? Secondary objectives include determining the best timing for [18F]mFBG PET-CT imaging, correlating PET findings with pathology results, estimating radiation doses in normal tissues, and analyzing the safety of [18F]mFBG administration.
  • Are there any specific exclusion criteria for the trial? Yes, patients who are mentally or legally incapacitated, pregnant or breastfeeding, have uncontrolled active infections, are unable or unwilling to undergo PET-CT scanning or surgery, or have received interfering treatments between CT and PET-CT scans are excluded from the trial.

Ongoing Clinical Trials on M-(18F)-Fluorobenzylguanidine

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

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • Pheochromocytoma: A rare type of tumor that develops in the adrenal glands, which are located on top of the kidneys. These tumors can cause the body to produce too many hormones, leading to various symptoms.
  • PET-CT: Positron Emission Tomography-Computed Tomography, a combined imaging technique that provides detailed pictures of both the structure and function of tissues and organs in the body.
  • [18F]mFBG: M-(18F)-Fluorobenzylguanidine, a radioactive tracer used in PET-CT imaging to help detect certain types of tumors, including pheochromocytoma.
  • Histology: The study of the microscopic structure of tissues. In this context, it refers to the examination of tissue samples to confirm the presence of tumor cells.
  • ECOG status: Eastern Cooperative Oncology Group performance status, a scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • Metanefrines: Substances produced when the body breaks down hormones made by adrenal tumors. Elevated levels in blood or urine can indicate the presence of a pheochromocytoma.
  • SUV: Standardized Uptake Value, a measure used in PET imaging to show how much of a radioactive tracer is taken up by tissue, helping to identify areas of concern.
  • PATLAK imaging: A method used to analyze dynamic PET data, helping to estimate how much of a tracer substance is taken up by tissues over time.
  • Immunohistochemistry: A laboratory technique that uses antibodies to detect specific proteins in tissues, helping to identify certain types of cells or markers of disease.
  • Norepinephrine transporter: A protein responsible for the uptake of certain hormones (including norepinephrine) into cells. It is often present in pheochromocytoma cells and can be targeted by imaging tracers.

References

  1. http://clinicaltrials.eu/trial/study-on-18fmfbg-pet-ct-imaging-for-patients-with-pheochromocytoma/