32 Participants NeededMy employer runs this trial

[18F]GATT-44 for Imaging

SH
KR
Overseen ByKayla R Cottiers
Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: Yale University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging tracer called [18F]GATT-44 to observe its behavior in the body and its binding efficiency to specific targets, particularly the GABA Transporter (GAT-1). The study consists of three parts: assessing the reliability of [18F]GATT-44 in repeated tests, evaluating its target binding, and measuring its distribution in the body. Healthy individuals without significant medical issues or claustrophobia, who can follow study instructions, may be suitable candidates. This trial plays a crucial role in developing improved imaging methods for diagnosing and understanding certain conditions. As an Early Phase 1 trial, this research aims to understand how this new tracer functions in people, offering participants the chance to contribute to groundbreaking imaging advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking anticoagulants (blood thinners), you cannot participate in the trial.

What prior data suggests that [18F]GATT-44 is safe for imaging in humans?

Research shows that [18F]GATT-44 is a new substance being tested to help visualize certain brain activities. Currently, there is limited information about its safety for people. This trial is in the early stages, focusing on how the body processes the substance and identifying any side effects.

As an imaging substance, similar substances are usually well-tolerated. Studies often examine how the substance moves and acts in the body. Safety concerns might include mild reactions, but serious side effects are rare at this stage. However, because [18F]GATT-44 is still under investigation, solid safety data from past studies is not yet available.

Prospective participants should discuss any concerns with the trial team. They can provide more details about what to expect with the substance and any possible risks.12345

Why are researchers excited about this trial?

Researchers are excited about [18F]GATT-44 because it offers a new way to visualize and understand the GABA Transporter (GAT-1) in the brain, which could enhance the diagnosis and monitoring of neurological conditions. Unlike current imaging techniques, this novel tracer specifically targets GAT-1, potentially providing clearer and more detailed images of its activity. This can lead to more accurate assessments of brain function and aid in the development of targeted treatments for conditions related to GABA regulation.

What evidence suggests that this trial's imaging tracer could be effective?

Research has shown that [18F]GATT-44 is a promising new tool for brain imaging. It targets GABA Transporter-1 (GAT-1), which controls brain chemicals. In studies, [18F]GATT-44 outperformed similar tools by showing clear images and binding well to its target. It remains stable in the body, with over 75% unchanged after a period, enhancing image quality. This tracer aims to reveal brain activity more clearly, potentially leading to better understanding and treatment of related conditions. These findings encourage its effectiveness in imaging GAT-1 in the brain. Participants in this trial will engage in various study parts, including test/retest, test-blocking, and whole-body imaging, to further evaluate [18F]GATT-44's performance and characteristics.13467

Who Is on the Research Team?

RE

Richard E Carson, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 to 60 who are in good general health, can follow study instructions, and agree to use birth control if needed. People can't join if they are pregnant or breastfeeding, have bleeding disorders, certain medical conditions, claustrophobia, or too much prior radiation exposure.

Inclusion Criteria

Able to read and write, able to communicate effectively with the investigator, and comply with all study requirements, restrictions, and directions of the research staff
I am in good overall health based on recent medical tests.
I am willing to use birth control during the study.
See 2 more

Exclusion Criteria

Pregnant or breastfeeding
I am younger than 18 years old.
I have a history of bleeding problems or I am currently taking blood thinners.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Test/Retest

Conduct a test/retest study of the novel GABA Transporter (GAT-1) imaging tracer [18F]GATT44 in humans to characterize its pharmacokinetic behavior and determine the reliability and reproducibility of in vivo pharmacokinetic parameter measurements

2 days
2 visits (in-person)

Test-Blocking

Conduct a test-blocking study to assess specific binding levels of [18F]GATT44 in humans

1 day
1 visit (in-person)

Whole Body Imaging

Estimate human dosimetry of [18F]GATT44 by performing whole-body imaging studies

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • [18F]GATT-44

Trial Overview

The study tests a new imaging agent called [18F]GATT-44 used in PET scans to see how it behaves in the body and how well it binds to its target. The research involves whole-body imaging and test-block studies with healthy volunteers.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Healthy Control - Whole BodyExperimental Treatment1 Intervention
Group II: Healthy Control - Test/RetestExperimental Treatment1 Intervention
Group III: Healthy Control - Test-BlockingExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Citations

Study Details | NCT07457736 | Evaluation of [18F]GATT-44 ...

Assess specific binding levels of [18F]GATT-44 by conducting a test-block study in humans. Estimate human dosimetry of [18F]GATT-44 by performing whole-body ...

Toward Imaging of the GABA Transporter Type 1 In Vivo - PMC

The 2 remaining radiotracers had similar characteristics, with 18F-GATT-44 showing slightly superior performance over 18F-GATT-31, with more ...

Kinetic modeling of novel radiotracers for the GABA ...

The focus of this work is to evaluate the kinetic behavior of two novel F-18 PET radiotracers ([18F]GATT-34 and [18F]GATT-44) for imaging the ...

Kinetic modeling of novel radiotracers for the GABA ...

The focus of this work is to evaluate the kinetic behavior of two novel F-18 PET radiotracers. ([18F]GATT-34 and [18F]GATT-44) for imaging the ...

Evaluation of [18F]GATT-44 for Positron Emission ... - MedPath

Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1 ... Outcome data and publication updates.

First-in-Human Study of 18F-Labeled PET Tracer for ... - PMC

PET is a nuclear medicine imaging modality widely used in clinical diagnosis. Despite the development of many AMPAR-targeted PET probes, the ...

Fludeoxyglucose (18F) - StatPearls - NCBI Bookshelf - NIH

Fludeoxyglucose F18 is a radioactive tracer that acts as a glucose analog and is used for diagnostic purposes in conjunction with positron-emitting tomography ...