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PRA-GEHBEL79-0D1OHH

MRT-Untersuchung

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

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

Very positive, professional and a nice location.

Emma

Participant ICON

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.

Wie funktioniert es

Wie funktioniert es?

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Study groups

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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

Sie dürfen höchstens 4 Mal pro Jahr an einer Studie teilnehmen. Zwischen zwei Studien müssen mindestens 30 Tage liegen. Für einige Studien gilt eine längere Wartezeit.

Während der Studie können leichte Beschwerden wie Kopfschmerzen oder Übelkeit auftreten. Dies kann durch das Medikament verursacht werden. Aber es kann zum Beispiel auch daran liegen, dass Sie für die Studie nüchtern bleiben müssen. Diese Nebenwirkungen sind unangenehm, aber glücklicherweise nicht gefährlich.

Bevor ein Medikament am Menschen erprobt werden darf, wurde es bereits umfassend in einem Labor getestet. So lässt sich gut vorhersagen, welche Nebenwirkungen eventuell bei Ihnen auftreten werden, damit Sie sich darauf einstellen können. So kommt es fast nie vor, dass Teilnehmer unter unerwarteten Nebenwirkungen leiden.

Eine Studie umfasst in der Regel fünf bis zwölf Teilnehmer. Die Gruppen werden so zusammengestellt, dass sie optimal zu den Anforderungen der Studie passen. Diese Anforderungen sind in jeder Studie beschrieben. Sehen Sie sich alle aktuellen Studien an.

ICON führt häufig Studien mit radioaktiv markierten Medikamenten durch. Damit können wir untersuchen, wie und wie schnell das Medikament im Körper aufgenommen, verarbeitet und ausgeschieden wird. Bei einer Studie mit radioaktiv markiertem Medikament ist das Risiko von Nebenwirkungen geringer als bei anderen Studien. In diesen Studien wird eine viel geringere Dosis verabreicht. Erfahren Sie mehr über Studien mit radioaktiv markierten Medikamenten.

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