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[89ZR]ZR-DFO-CIT-013

This article discusses clinical trials investigating [89Zr]Zr-DFO-CIT-013, a radiolabeled imaging agent used in PET-CT scans. The trials aim to evaluate how this substance distributes throughout the body in patients with inflammatory mediated immune diseases (IMIDs). The research focuses on understanding the uptake patterns of [89Zr]Zr-DFO-CIT-013 in different organs and comparing these patterns across various inflammatory conditions.

Table of Contents

Overview of [89Zr]Zr-DFO-CIT-013 Clinical Research

Clinical research is currently underway to evaluate [89Zr]Zr-DFO-CIT-013, a specialized imaging agent designed for use in PET-CT scanning[1]. This substance is being investigated specifically in patients who have inflammatory mediated immune diseases (IMIDs), which are conditions where the body’s immune system causes ongoing inflammation[1]. The research aims to understand how this radiolabeled compound distributes throughout the body and accumulates in different organs and tissues.

The trial registered as NCT07147959 is titled “PET-Based Imaging of Radiolabeled CIT-013” and has received authorization to proceed[1]. This study represents an important step in developing new imaging tools that could help doctors better understand and diagnose inflammatory immune diseases. By tracking where [89Zr]Zr-DFO-CIT-013 goes in the body, researchers hope to gain insights into how different inflammatory conditions affect various organs and systems.

The research is classified as an interventional study, meaning that participants receive a specific treatment or diagnostic procedure as part of the trial protocol[1]. In this case, the intervention involves administering the radiolabeled imaging agent and performing specialized scans to track its distribution. This type of study is essential for determining whether new imaging techniques can provide valuable information for patient care.

Trial Design and Methodology

The clinical trial investigating [89Zr]Zr-DFO-CIT-013 is designed as a Phase 2 study, which means it builds upon earlier safety research and focuses on evaluating how well the imaging agent works in a specific patient population[1]. Phase 2 trials typically involve a larger number of participants than Phase 1 studies and gather more detailed information about the treatment or diagnostic tool being tested.

The trial plans to enroll a total of 12 patients with inflammatory mediated immune diseases[1]. While this may seem like a small number, it is appropriate for an imaging study focused on understanding distribution patterns and establishing baseline data. The relatively small enrollment allows researchers to conduct detailed, individualized assessments of each participant’s imaging results.

Administration Protocol

Participants in the trial receive [89Zr]Zr-DFO-CIT-013 through intravenous injection, which means the substance is delivered directly into a vein[1]. The dose used in the study is 20 milligrams, which has been selected based on previous research to provide adequate imaging while maintaining safety[1]. This method of administration ensures that the radiolabeled compound enters the bloodstream quickly and can circulate throughout the body to reach different organs and tissues.

The study protocol specifies that imaging takes place at a specific timepoint after administration. Researchers have chosen to perform the main imaging assessment 24 hours after injection, which corresponds to Day 2 of the study (D2)[1]. This timing allows the substance to distribute throughout the body and for any initial rapid clearance to occur, providing a clearer picture of where the compound accumulates.

Patient Population and Eligibility

The trial specifically targets patients diagnosed with inflammatory mediated immune diseases (IMIDs)[1]. This is a broad category that includes various conditions where the immune system causes chronic inflammation in the body. These diseases can affect different organs and systems, and understanding how inflammation manifests in different parts of the body is crucial for proper diagnosis and treatment.

The study design includes multiple cohorts, which are separate groups of patients with different types of inflammatory immune diseases[1]. By organizing participants into cohorts based on their specific condition, researchers can compare how [89Zr]Zr-DFO-CIT-013 distributes differently in various types of IMIDs. This comparative approach helps identify whether certain inflammatory conditions show distinct patterns of uptake in particular organs or tissues.

Why Study IMIDs?

Inflammatory mediated immune diseases represent a significant challenge in modern medicine because they can affect multiple body systems and often require specialized imaging to assess disease activity. Current imaging techniques may not always provide complete information about where inflammation is occurring or how severe it is. By developing new imaging agents like [89Zr]Zr-DFO-CIT-013, researchers hope to create better tools for:

  • Disease detection: Identifying areas of active inflammation that might not be visible with standard imaging
  • Disease monitoring: Tracking how inflammation changes over time or in response to treatment
  • Treatment planning: Helping doctors understand which organs or systems are most affected by inflammation
  • Research advancement: Improving scientific understanding of how different inflammatory conditions affect the body

Imaging Procedure and Assessment

The core of this clinical trial involves whole body PET-CT imaging, a sophisticated scanning technique that combines two different imaging technologies[1]. PET (Positron Emission Tomography) detects the radioactive signal from [89Zr]Zr-DFO-CIT-013, showing where the substance has accumulated in the body. CT (Computed Tomography) provides detailed anatomical images, helping to precisely locate the areas of uptake.

The imaging protocol includes both visual assessment and quantitative measurement[1]. Visual assessment involves radiologists and nuclear medicine physicians examining the images to identify patterns and areas of increased uptake. Quantitative measurement uses specialized software to calculate exact amounts of [89Zr]Zr-DFO-CIT-013 in different regions, providing numerical data that can be compared across patients and cohorts.

Quantification Methods

Researchers measure the uptake of [89Zr]Zr-DFO-CIT-013 per organ and organ-system[1]. This detailed approach allows them to create comprehensive maps of how the imaging agent distributes throughout the body. Individual organs such as the liver, spleen, kidneys, and lymph nodes are assessed separately, while organ systems (like the cardiovascular system or digestive system) are evaluated as functional units.

The trial protocol specifies that in vivo distribution profiles will be evaluated for each cohort[1]. “In vivo” means “in the living body,” so these profiles represent real-time data about how [89Zr]Zr-DFO-CIT-013 behaves in actual patients rather than in laboratory settings. By analyzing these profiles, researchers can determine the ranges of uptake per organ-system, establishing what levels of accumulation are typical for different parts of the body[1].

Comparative Analysis

One of the key features of this trial is the comparison between cohorts to evaluate uptake in different IMIDs[1]. This comparative approach helps researchers understand whether different inflammatory conditions show distinct patterns of [89Zr]Zr-DFO-CIT-013 distribution. For example, one type of inflammatory disease might show higher uptake in joint tissues, while another might show more accumulation in the digestive system.

Research Objectives and Outcomes

The primary objective of this clinical trial is straightforward but important: to evaluate the distribution of radiolabeled CIT-013 in patients with inflammatory mediated immune diseases[1]. This objective drives all aspects of the study design, from patient selection to imaging protocols to data analysis methods.

Primary Outcome Measures

The trial’s primary outcome is measured through the whole body PET-CT imaging performed 24 hours after administration[1]. This timepoint was specifically chosen because it allows sufficient time for the imaging agent to distribute throughout the body while the radioactive signal remains strong enough for clear imaging. The assessment includes:

  • Visual evaluation: Expert review of images to identify patterns and areas of interest
  • Quantitative analysis: Numerical measurements of uptake in specific organs and regions
  • Distribution mapping: Creating comprehensive profiles showing where [89Zr]Zr-DFO-CIT-013 accumulates
  • Range determination: Establishing normal ranges of uptake for different organs and systems
  • Comparative assessment: Analyzing differences between various types of inflammatory diseases

What the Data Will Show

By completing this trial, researchers expect to gain detailed information about how [89Zr]Zr-DFO-CIT-013 behaves in the human body. The data collected will help answer several important questions:

  • Which organs show the highest uptake of the imaging agent?
  • How does uptake vary between different patients with the same condition?
  • Are there distinct patterns of distribution for different types of inflammatory diseases?
  • What are the typical ranges of uptake that can be expected in various organs?
  • Can the imaging identify areas of inflammation that might not be detected by other methods?

Clinical Significance

This clinical trial represents an important step in developing new diagnostic tools for inflammatory immune diseases. Currently, doctors rely on various imaging techniques, blood tests, and clinical assessments to evaluate these conditions. Each method has strengths and limitations, and there is ongoing need for better ways to visualize and measure inflammation throughout the body.

Potential Applications

If [89Zr]Zr-DFO-CIT-013 proves effective as an imaging agent, it could have several important applications in clinical practice:

  • Comprehensive disease assessment: Providing a whole-body view of inflammatory activity rather than focusing on single organs
  • Treatment monitoring: Tracking how inflammation responds to therapy over time
  • Early detection: Identifying inflammatory changes before they cause significant symptoms or damage
  • Personalized medicine: Helping doctors tailor treatments based on each patient’s specific pattern of inflammation
  • Research tool: Advancing scientific understanding of how inflammatory diseases develop and progress

Study Status and Timeline

The trial has received authorization to proceed, which means regulatory authorities have reviewed the protocol and determined it is safe and scientifically sound[1]. With a planned enrollment of 12 patients, the study is designed to be completed in a reasonable timeframe while gathering sufficient data to meet its objectives. As a Phase 2 trial, the results will help determine whether further research with larger patient populations is warranted.

Future Directions

The data generated from this trial will inform future research decisions. If [89Zr]Zr-DFO-CIT-013 shows promising distribution patterns and provides useful diagnostic information, it could move forward to larger Phase 3 trials. These later-stage studies would involve more patients and would evaluate whether the imaging agent provides clinical benefits compared to existing diagnostic methods.

The comparative analysis between different cohorts of inflammatory diseases is particularly valuable because it may reveal whether [89Zr]Zr-DFO-CIT-013 is most useful for specific types of IMIDs or whether it has broad applicability across various inflammatory conditions. This information will help guide the development strategy for the imaging agent and identify the patient populations most likely to benefit.

Trial ID Phase Condition Studied Status Enrollment Intervention Primary Outcome
NCT07147959 Phase 2 Inflammatory mediated immune diseases Authorised 12 patients [89Zr]Zr-DFO-CIT-013, 20 mg, IV injection Whole body PET-CT imaging 24 hours after administration to evaluate distribution and uptake per organ-system

FAQ

  • What is being studied in the [89Zr]Zr-DFO-CIT-013 clinical trial? The trial is studying how [89Zr]Zr-DFO-CIT-013 distributes throughout the body in patients with inflammatory mediated immune diseases. Researchers use PET-CT imaging to track where the substance goes and how much accumulates in different organs.
  • Who can participate in the [89Zr]Zr-DFO-CIT-013 trial? The trial is designed for patients diagnosed with inflammatory mediated immune diseases (IMIDs). These are conditions where the immune system causes inflammation in the body.
  • What phase is the [89Zr]Zr-DFO-CIT-013 trial in? The trial is currently in Phase 2, which focuses on evaluating how the imaging agent works in a specific patient population and gathering more detailed information about its distribution patterns.
  • How is [89Zr]Zr-DFO-CIT-013 administered in the trial? The substance is given as an intravenous injection at a dose of 20 milligrams. After administration, patients undergo PET-CT imaging to track how the substance distributes in their body.
  • What is the purpose of using [89Zr]Zr-DFO-CIT-013 in PET imaging? The radiolabeled substance allows doctors to visualize and measure its distribution in different organs and tissues using PET-CT scans. This helps researchers understand how inflammatory immune diseases affect different parts of the body.

Ongoing Clinical Trials on [89ZR]ZR-DFO-CIT-013

  • Study Using PET Imaging to See How [89Zr]Zr-DFO-CIT-013 Spreads in Patients with Inflammatory Mediated Immune Diseases

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • PET-CT Imaging: A medical imaging technique that combines Positron Emission Tomography (PET) and Computed Tomography (CT) to create detailed pictures of the inside of the body, showing both structure and function.
  • Radiolabeled: A substance that has been tagged with a radioactive marker so it can be tracked in the body using special imaging equipment.
  • Inflammatory Mediated Immune Diseases (IMIDs): A group of conditions where the immune system mistakenly attacks the body's own tissues, causing chronic inflammation. Examples include rheumatoid arthritis, inflammatory bowel disease, and psoriasis.
  • Intravenous Injection: A method of delivering medication or substances directly into a vein through a needle or catheter.
  • Distribution: The process by which a substance spreads throughout different parts of the body after being administered.
  • Uptake: The amount of a substance that is absorbed or accumulated by specific organs or tissues in the body.
  • Phase 2 Trial: A stage of clinical research that tests how well a treatment or diagnostic tool works in a specific group of patients and gathers more information about its effects.
  • Cohort: A group of participants in a research study who share similar characteristics or receive the same treatment.
  • Organ-System: A group of organs that work together to perform specific functions in the body, such as the digestive system or cardiovascular system.
  • Whole Body Imaging: A scanning technique that captures images of the entire body to evaluate how a substance distributes throughout all organs and tissues.

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