Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A Study to Assess the Effectiveness of Different Doses of GEH200486 Injection for Contrast-enhanced Head and Neck MRI in Healthy Volunteers

This research is about a new injection, GEH200486, which helps make MRI scans of the head and neck clearer. MRI scans use strong magnets and radio waves to create detailed pictures inside your body. Sometimes, a special dye or 'contrast agent' like GEH200486 is injected to make certain parts of the body show up better on the scan. This study aims to find out which dose of GEH200486 works best and is safest for making these scans clear. It's a very early stage study, typically done with healthy volunteers, and it's not looking into treating any illnesses, just improving the imaging technique itself.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

GE Healthcare Limited

Enrolment target

Start

08 Nov 2024

None - imaging technique

What is this study about?

Imagine you're trying to see details inside a tightly packed box. Sometimes, it's hard to tell things apart. In medicine, MRI scans are like taking pictures inside your body. For areas like your head and neck, doctors sometimes use a special liquid, called a 'contrast agent,' which is injected into your body. This liquid helps certain parts of your body stand out more clearly on the MRI pictures.

This study is testing a new contrast agent called GEH200486. The main goal is to figure out the best amount, or 'dose,' of this injection to give people so that head and neck MRI scans are as clear as possible. Finding the right dose is really important because it means doctors can get the best information from the scans while also making sure it's as safe as possible for the patient.

This is a very early stage study, often called 'Phase 1'. This means it's one of the first times this new injection is being used in people. It's not about treating a disease, but about making a medical tool – the MRI scan – work better and more safely for everyone in the future.

Key takeaways

This study tests a new injection (GEH200486) for clearer MRI scans.
It aims to find the best and safest amount (dose) of the injection.
Healthy adult volunteers are needed.
It's about improving imaging technology, not treating illnesses.
Participation involves injections, MRI scans, and health checks.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for healthy adults to take part. To be eligible, you need to be at least 18 years old. There is no upper age limit, meaning older adults can also participate.

We are looking for people who are generally well and don't have any major health problems. This is because the study is focused on how the injection works in a healthy body, rather than how it might interact with existing conditions. Both men and women are welcome to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you generally healthy, without significant medical conditions?
Are you comfortable having injections and MRI scans?
Are you able to attend several clinic visits for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the GEH200486 injection. The study will involve several visits to the clinic to receive different doses of the injection as part of the testing. You would undergo MRI scans of your head and neck after each injection to see how well it works. There will also be health checks, such as blood tests and physical examinations, to make sure you remain healthy throughout the study. The total time you'll be involved in the study will be explained in detail by the study team, including how long each visit might last and how many visits are needed.

Potential risks and benefits

The main benefit of taking part is contributing to medical science and helping improve future medical imaging for many people. You will receive very thorough health checks during the study. Potential risks, though usually minor in studies like this, could include discomfort from injections, or very rarely, an allergic reaction to the contrast agent. You would be fully informed of all known risks before joining, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is GEH200486?

It's a new liquid, called a contrast agent, that helps make MRI scans clearer. It's injected into your body before the scan.

Why do I need to be healthy to join?

This study wants to see how the injection works in a healthy body, without other health conditions affecting the results.

What is an MRI scan?

MRI stands for Magnetic Resonance Imaging. It's a type of scan that uses strong magnets and radio waves to create detailed pictures inside your body.

Will this injection treat any illness?

No, this study is not looking for a treatment. It's only focused on making MRI scans better for diagnosing things in the future.

What does 'dose' mean?

The 'dose' is the specific amount of the GEH200486 injection you would receive.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.