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PRA-GEHBEL79-0D1OHH

MRI-scan

  • M/F
  • 18 - 60 years old
  • Healthy

Clinical trial of a new contrast agent that is being developed for use with MRI-scans

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Very positive, professional and a nice location.

Emma

Participant ICON

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Find out if you qualify for this trial

  • You are a healthy male or female
  • You are between 18 and 60 years old
  • You weigh between 50 and 120 kg
  • Your Body Mass Index (BMI) is between 18.1 and 31.9 kg/m2

Good to know about this trial

  • In this study, the safety of a new contrast agent is investigated when administered to healthy volunteers, no new medicine will be tested. Read more about how a contrast agent works at: "the research physician about this research" above.
  • The new contrast agent has been administered to people before.
  • After the period of stay half of the compensation will be paid.

Download the complete research overview.

How does it work

How does it work?

  1. 1.

    Registering

    Register for the trail and the group you choose. After your registration, call ICON to discuss the study and make an appointment for your medical examination. This can be done from the next working day after your registration.

  2. 2.

    Medical screening

    If you meet the requirements of the trial, then a medical screening takes place at our screening center in Groningen or Utrecht.

  3. 3.

    The trial

    The clinical trial is conducted at ICON's research center in Groningen. There you will eat, sleep and stay during the trial.

  4. 4.

    Follow-up & Compensation

    A follow-up screening always takes place after the trial. You will receive the compensation for your participation, within 30 days.

Read more

Study groups

Register without obligation for the group of your preference

  • Group 1

    • 18 September up to and including 1 October

    Period(s) of stay (14 days)

    • 18 September up to and including 1 October

    • 31 December

    Follow-up

    • 31 December

    • €5425,-

    Compensation

    • €5425,-

    Based on the MRI scan of the first follow-up, it is determined whether it is necessary to come back for a visit. If necessary, follow up 2 + MRI scan: March 31st 2024. If necessary, follow up 3 + MRI scan: October 1st 2024.

    Note

    Based on the MRI scan of the first follow-up, it is determined whether it is necessary to come back for a visit. If necessary, follow up 2 + MRI scan: March 31st 2024. If necessary, follow up 3 + MRI scan: October 1st 2024.

    Full

  • Group 2

    • 9 up to and including 22 October

    Period(s) of stay (14 days)

    • 9 up to and including 22 October

    • 21 January

    Follow-up

    • 21 January

    • €5425,-

    Compensation

    • €5425,-

    Based on the MRI scan of the first follow-up, it is determined whether it is necessary to come back for a visit. If necessary, follow up 2 + MRI scan: April 21st 2024. If necessary, follow up 3 + MRI scan: October 22nd 2024.

    Note

    Based on the MRI scan of the first follow-up, it is determined whether it is necessary to come back for a visit. If necessary, follow up 2 + MRI scan: April 21st 2024. If necessary, follow up 3 + MRI scan: October 22nd 2024.

    Full

  • Group 3

    • 30 October up to and including 12 November

    Period(s) of stay (14 days)

    • 30 October up to and including 12 November

    • 11 February

    Follow-up

    • 11 February

    • €5425,-

    Compensation

    • €5425,-

    Based on the MRI scan of the first follow-up, it is determined whether it is necessary to come back for a visit. If necessary, follow up 2 + MRI scan: May 12th 2024. If necessary, follow up 3 + MRI scan: November 12th 2024.

    Opmerking

    Based on the MRI scan of the first follow-up, it is determined whether it is necessary to come back for a visit. If necessary, follow up 2 + MRI scan: May 12th 2024. If necessary, follow up 3 + MRI scan: November 12th 2024.

    Full

  • Group 4

    • 18 up to and including 31 December

    Period(s) of stay (14 days)

    • 18 up to and including 31 December

    • 31 March

    Follow-up

    • 31 March

    • €5425,-

    Compensation

    • €5425,-

    Based on the MRI scan of the first follow-up, it is determined whether it is necessary to come back for a visit. If necessary, follow up 2 + MRI scan: June 30th 2024. If necessary, follow up 3 + MRI scan: December 31st 2024.

    Note

    Based on the MRI scan of the first follow-up, it is determined whether it is necessary to come back for a visit. If necessary, follow up 2 + MRI scan: June 30th 2024. If necessary, follow up 3 + MRI scan: December 31st 2024.

    Full

  • Group 5

    • 22 January up to and including 4 February

    Period(s) of stay (14 days)

    • 22 January up to and including 4 February

    • 6 May

    Follow-up

    • 6 May

    • €5425,-

    Compensation

    • €5425,-

    Based on the MRI scan of the first follow-up, it is determined whether it is necessary to come back for a visit. If necessary, follow up 2 + MRI scan: August 4th, 2024. If necessary, follow up 3 + MRI scan: February 4th, 2025

    Note

    Based on the MRI scan of the first follow-up, it is determined whether it is necessary to come back for a visit. If necessary, follow up 2 + MRI scan: August 4th, 2024. If necessary, follow up 3 + MRI scan: February 4th, 2025

    Full

  • Group 6

    • 5 up to and including 18 February

    Period(s) of stay (14 days)

    • 5 up to and including 18 February

    • 19 May

    Follow-up

    • 19 May

    • €5425,-

    Compensation

    • €5425,-

    Based on the MRI scan of the first follow-up, it is determined whether it is necessary to come back for a visit. If necessary, follow up 2 + MRI scan: August 18th, 2024. If necessary, follow up 3 + MRI scan: February 18th, 2025

    Note

    Based on the MRI scan of the first follow-up, it is determined whether it is necessary to come back for a visit. If necessary, follow up 2 + MRI scan: August 18th, 2024. If necessary, follow up 3 + MRI scan: February 18th, 2025

    Full

  • Group 7

    • alleen plek over voor vrouwen

    • 19 February up to and including 3 March

    Period(s) of stay (14 days)

    • 19 February up to and including 3 March

    • 2 June

    Follow-up

    • 2 June

    • €5425,-

    Compensation

    • €5425,-

    Based on the MRI scan of the first follow-up, it is determined whether it is necessary to come back for a visit. If necessary, follow up 2 + MRI scan: September 01st 2024. If necessary, follow up 3 + MRI scan: March 4th 2025.

    Note

    Based on the MRI scan of the first follow-up, it is determined whether it is necessary to come back for a visit. If necessary, follow up 2 + MRI scan: September 01st 2024. If necessary, follow up 3 + MRI scan: March 4th 2025.

    Full

  • Groep 8

    • ALLEEN PLEK OVER VOOR VROUWEN

    • 11 up to and including 24 March

    Period(s) of stay (14 days)

    • 11 up to and including 24 March

    • 23 June

    Follow-up

    • 23 June

    • €5425,-

    Compensation

    • €5425,-

    Let op! Op basis van de MRI scan van de eerste nakeuring wordt bepaald of het nodig is om nogmaals terug te komen voor een bezoek. Indien nodig nakeuring 2 + MRI scan: 22 september 2024. Indien nodig nakeuring 3 + MRI scan: 25 maart 2025.

    Opmerking

    Let op! Op basis van de MRI scan van de eerste nakeuring wordt bepaald of het nodig is om nogmaals terug te komen voor een bezoek. Indien nodig nakeuring 2 + MRI scan: 22 september 2024. Indien nodig nakeuring 3 + MRI scan: 25 maart 2025.

    Full

The research physician about this research

Additional information

  • In this study, the safety of a new contrast agent is investigated when administered to healthy volunteers. A contrast agent is a liquid that is administered when making medical images (an MRI scan, for example) to better distinguish different tissues in the body from each other. In this study the contrast agent will be given as an intravenous infusion.
  • During the trial your heart rhythm will be continuously monitored during certain moments. You will be given electrodes (small, plastic patches) on your chest and abdomen that are connected to a portable device.
  • The first entry in the research center will be preceded by one short visit. During this short visit, a brain MRI-scan (which is a part of the medical screening) will be performed. The brain MRI-scan will also be done at the short visits (1 to 3 visits) during the study.

Für Deutschland: Bitte beachten Sie: Die Arzneimittelstudien finden im niederländischen Groningen statt. Sie müssen Englisch oder Niederländisch sprechen, verstehen und lesen können, um an einer Studie teilnehmen zu können. 

Who can participate?

Target group

  • You are a healthy male or female.
  • You are at least 18 and at most 60 years old.
  • You weigh at least 40 kg (for females) / 50 kg (for males) and no more than 120 kg (for both males and females) and your Body Mass Index (BMI) is higher than or equal to 18.1 and lower than or equal to 31.9 kg/m2.
  • Both non-smokers and light smokers (maximum of 5 cigarettes per day) are allowed to participate in this clinical trial. During your stay in our research facility you are not allowed to smoke.

Note:

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first administration in this clinical trial (counting from the last administration).
  • To determine if you are suitable to participate in this trial, you will undergo a medical screening. The medical screening consists of two separate visits. After the regular medical screening at ICON there will be an additional visit to perform an MRI scan.

As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:

  • You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones);
  • You have passed the menopause (no periods for at least 12 months);
  • You have been sterilized or your male partner has been sterilized;
  • You are not sexually active according to your lifestyle;
  • You are only sexually active with a partner of the same sex.

Please note: Copper IUD is not allowed due to the MRI-scan.

As a male you can only participate if you meet one of the following conditions:

  • You are using a condom in combination with an additional contraception method used by your female partner;
  • You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
  • You are not sexually active according to your lifestyle;
  • You are only sexually active with a partner of the same sex.

WHAT IS THE COMPENSATION FOR THIS RESEARCH?

Compensation

You will receive a gross compensation of € 5425,-  for participation in this study.

Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 176.40 (840 kilometers) per round trip, regardless of the mode of transportation.

HOW LONG DOES THIS RESEARCH TAKE

Period of stay and research

The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 14 days (13 nights), followed by a minimum of 1 and a maximum of 3 short visits.

Following each short visit you will be contacted by telephone within 14 days to inform you whether another short visit is needed. During the short visit(s) a brain MRI-scan will be done. Although it is most likely that only the first short visit is necessary it is good to be aware that the total study length could be quite long if all short visits (3 in total) are needed. 

Note: You must be available for all dates to be able to participate in this clinical trial. 

Frequently asked questions

You can participate in a trial a maximum of four times a year. There must be at least 30 days between two trials. Some trials have a longer waiting period.

During the trial, you may suffer from mild symptoms like headache or nausea. That may be caused by the medication. It might also be caused by needing to fast for the trial, for example. Those side effects are no fun, but fortunately are not dangerous.

Before a medication is tested on people, it has already been studied extensively in a lab. This enables us to predict well which side effects you might get and we can prepare you for them. It almost never happens that participants suffer from unexpected side effects. For example, an allergic reaction to the medication occurs on average once a year.

A trial usually involves 5 to 12 participants. The groups are set up so they best match the requirements of the trial. These requirements are described for each trial. View all current trials.

ICON often conducts trials with medication that is radioactive-labeled. We do that to be able to study how and how quickly the drug is absorbed, processed and eliminated by the body. In a trial with radioactive-labeled medication, you have less of a chance of side effects than in other trials. This is because a much lower dose is administered in these trials. Read more about trials with radioactive-labeled medication.

Current trials

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