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Ioflupane (123I)

Ioflupane (123I), also known as DaTSCAN™, is a radioactive drug being studied in clinical trials for its potential in diagnosing Parkinsonian syndromes. These trials aim to evaluate the safety, effectiveness, and diagnostic capabilities of Ioflupane (123I) when used in Single Photon Emission Computed Tomography (SPECT) imaging. The studies involve both healthy volunteers and patients with various movement disorders, focusing on the drug’s ability to detect striatal dopaminergic deficits associated with conditions like Parkinson’s disease.

Table of Contents

What is IOFLUPANE (123I)?

IOFLUPANE (123I), also known by its brand name DaTSCAN™, is a specialized diagnostic tool used in medical imaging[1]. It’s not a treatment or cure for any disease, but rather a substance that helps doctors visualize certain parts of the brain to aid in diagnosis. This radioactive medication is used in a type of scan called Single Photon Emission Computed Tomography (SPECT)[2].

How Does IOFLUPANE (123I) Work?

IOFLUPANE (123I) works by attaching to structures in the brain called dopamine transporters. These transporters are found in areas of the brain that control movement. In certain neurological conditions, the number of these transporters decreases. When IOFLUPANE (123I) is injected into the body, it travels to the brain and binds to these transporters. Special cameras can then detect where the IOFLUPANE (123I) has accumulated, creating images that show the distribution of dopamine transporters in the brain[2].

What Conditions Does IOFLUPANE (123I) Help Diagnose?

IOFLUPANE (123I) is primarily used to help diagnose a group of conditions known as Parkinsonian Syndromes. These include:

  • Parkinson’s Disease (PD): A progressive disorder that affects movement, balance, and coordination.
  • Multiple System Atrophy (MSA): A rare condition that causes symptoms similar to Parkinson’s disease but with more widespread effects on the body.
  • Progressive Supranuclear Palsy (PSP): A brain disorder that causes serious problems with walking, balance, and eye movements.

IOFLUPANE (123I) can also help differentiate these conditions from Essential Tremor, a neurological disorder that causes rhythmic shaking[2].

How is IOFLUPANE (123I) Administered?

IOFLUPANE (123I) is given as a single intravenous (IV) injection into a vein in the arm. The dose is carefully calculated based on the patient’s needs, but typically ranges from 111 to 185 megabecquerels (MBq). This may sound like a complex term, but it simply refers to the amount of radioactive material in the injection. The maximum volume of the injection is usually 5 milliliters (mL)[1][2].

Imaging Process

After receiving the IOFLUPANE (123I) injection, patients undergo SPECT imaging. This usually occurs between 3 to 6 hours after the injection and can last anywhere from 20 minutes to 1 hour. During this time, special cameras take pictures of the brain to show where the IOFLUPANE (123I) has accumulated[2].

Safety and Side Effects

As with any medical procedure, safety is a top priority when using IOFLUPANE (123I). Researchers closely monitor patients for any adverse events (unwanted side effects). These can range from mild issues like discomfort at the injection site to more serious events. However, it’s important to note that serious side effects are rare.

After receiving IOFLUPANE (123I), patients are monitored for changes in various health indicators, including:

  • Vital signs (blood pressure, heart rate, temperature, respiratory rate)
  • Blood tests
  • Urine tests
  • Physical examinations
  • Electrocardiogram (ECG) to check heart function

Patients also complete questionnaires about how they feel after the injection[1].

Ongoing Research

Scientists continue to study IOFLUPANE (123I) to better understand how it works in different populations. For example, recent studies have looked at its use in Chinese patients and healthy volunteers. These studies help researchers understand how the medication is distributed in the body, how it’s eliminated, and what radiation doses different organs receive[1][2].

This ongoing research helps to ensure that IOFLUPANE (123I) remains a safe and effective tool for diagnosing Parkinsonian Syndromes and differentiating them from conditions like Essential Tremor.

Aspect Details
Drug Name Ioflupane (123I), also known as DaTSCAN™
Administration Single intravenous injection, 111-185 MBq
Imaging Technique Single Photon Emission Computed Tomography (SPECT)
Target Conditions Parkinsonian syndromes, including Parkinson’s disease, multiple system atrophy, and progressive supranuclear palsy
Control Groups Essential tremor patients and healthy volunteers
Primary Outcomes Safety assessment, biodistribution, radiation dosimetry, diagnostic efficacy
Secondary Outcomes Striatal uptake analysis, adverse events monitoring
Safety Monitoring Adverse events, vital signs, physical examinations, laboratory tests, ECG
Image Analysis Blinded independent reads, semi-quantitative assessment using DaTQUANT™

FAQ

  • What is Ioflupane (123I) and how is it used in clinical trials? Ioflupane (123I), also known as DaTSCAN™, is a radioactive drug used in clinical trials. It is administered through intravenous injection and used in conjunction with Single Photon Emission Computed Tomography (SPECT) imaging. The trials aim to evaluate its safety and effectiveness in diagnosing Parkinsonian syndromes by detecting striatal dopaminergic deficits in the brain.
  • Who are the participants in these clinical trials? The clinical trials involve various groups of participants, including healthy volunteers, patients with Parkinsonian syndromes (such as Parkinson's disease, multiple system atrophy, and progressive supranuclear palsy), and patients with essential tremor. This diverse group allows researchers to compare the drug's effects and imaging results across different conditions.
  • What are the main objectives of these clinical trials? The main objectives of these trials are to assess the safety of Ioflupane (123I), evaluate its biodistribution in the body, measure internal radiation dosimetry, and determine its diagnostic efficacy. Researchers are particularly interested in the drug's ability to distinguish between conditions with and without striatal dopaminergic deficits.
  • How is the effectiveness of Ioflupane (123I) measured in these trials? The effectiveness of Ioflupane (123I) is measured through various methods, including SPECT imaging analysis, sensitivity and specificity calculations, and semi-quantitative assessment of striatal uptake ratios. Blinded independent readers evaluate the SPECT images to determine the presence or absence of striatal dopaminergic deficits.
  • What safety measures are being monitored in these clinical trials? The trials closely monitor participants for adverse events, changes in vital signs, physical examination findings, and laboratory test results. This includes tracking changes in blood chemistry, hematology, urinalysis, and electrocardiogram (ECG) findings. Researchers also assess the tolerability of the drug through questionnaires and injection site monitoring.

Ongoing Clinical Trials on Ioflupane (123I)

  • Study on the Safety and Effects of ACI-7104.056 in Patients with Early Parkinson’s Disease

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Spain

  • A study to test if BHV-8000 is effective and safe for adults with early Parkinson’s disease

    Not yet recruiting

    4 1 1
    Investigated drugs:
    Austria Belgium Czechia France Germany Italy +4

  • Study on the Long-Term Safety and Effectiveness of Minzasolmin and Iodine Ioflupane (123I) in Patients with Parkinson’s Disease

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy The Netherlands Poland Spain

  • Study on Neflamapimod for Treating Dementia with Lewy Bodies in Patients Aged 55 and Older

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • Ioflupane (123I): A radioactive drug used in medical imaging, specifically in Single Photon Emission Computed Tomography (SPECT), to help diagnose Parkinsonian syndromes.
  • SPECT: Single Photon Emission Computed Tomography, a type of nuclear imaging test that uses a radioactive tracer and a special camera to create 3D pictures of organs inside the body.
  • Parkinsonian Syndrome: A group of neurological disorders that cause movement problems similar to those seen in Parkinson's disease, such as tremors, slow movement, and stiffness.
  • Striatal Dopaminergic Deficit (SDD): A reduction in dopamine activity in the striatum, a part of the brain involved in movement control, which is characteristic of certain movement disorders.
  • Biodistribution: The way a substance, such as a drug, spreads throughout the body after it's administered.
  • Dosimetry: The measurement and calculation of radiation doses in the body.
  • Sensitivity: In medical testing, the ability of a test to correctly identify those with the disease (true positive rate).
  • Specificity: In medical testing, the ability of a test to correctly identify those without the disease (true negative rate).
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Region of Interest (ROI): A selected subset of samples within a dataset identified for a particular purpose, in this case, specific areas of the brain being examined in SPECT images.

References

  1. https://clinicaltrials.gov/study/NCT04564092
  2. https://clinicaltrials.gov/study/NCT04193527