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Trial record 8 of 12 for:    gadoteridol

Baseline Cortical Haemodynamics in MS (CortHaem)

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ClinicalTrials.gov Identifier: NCT02481882
Recruitment Status : Recruiting
First Posted : June 25, 2015
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
This study will provide information on cortical haemodynamics in MS patients to address the discrepancies reported in previous literature, allowing further insight into the role of haemodynamics in the disease. It will also instruct us as to the most effective scanning protocols for future research. Developing a suitable protocol for studying perfusion longitudinally may also enable identification of new therapeutic interventions to normalise any perfusion abnormalities in MS patients.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Magnetic Resonance Imaging Drug: Prohance (Gadoteridol) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigating Baseline Cortical Haemodynamics in Multiple Sclerosis
Actual Study Start Date : January 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Gadoteridol

Arm Intervention/treatment
Healthy Volunteers
Healthy Volunteers will undergo an Magnetic Resonance Imaging scan.
Device: Magnetic Resonance Imaging
All scanning will be performed using a 7 Tesla Philips Achieva scanner with multi-transit capability (Philips Medical Systems, Best, The Netherlands). The volunteers will be scanned with a 32-channel receive coil.

MS Patients
Patients will undergo and Magnetic Resonance Imaging scan including the use of Prohance (Gadoteridol).
Device: Magnetic Resonance Imaging
All scanning will be performed using a 7 Tesla Philips Achieva scanner with multi-transit capability (Philips Medical Systems, Best, The Netherlands). The volunteers will be scanned with a 32-channel receive coil.

Drug: Prohance (Gadoteridol)
A gadolinium based liquid administered intravenously in order to quantify blood flow in the brain using an MR scanner.




Primary Outcome Measures :
  1. Cerebral Blood Flow [ Time Frame: 1 hour ]
    A short MRI scan is able to quantify the amount of blood perfusion into brain tissue (to be performed with and without the gadolinium contrast agent).


Secondary Outcome Measures :
  1. Arterial Cerebral Blood Volume [ Time Frame: 1 hour ]
    A short MRI scan is able to quantify the volume of arterial blood in a volume of brain tissue.

  2. Arterial Transit Time [ Time Frame: 1 hour ]
    A short MRI scan is able to quantify the amount of time taken for blood to reach an area of the brain.



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (Healthy Volunteers):

  • Male or female volunteers who are between the ages of 21 and 80.
  • Able to give voluntary written informed consent to participate in the study.
  • Able to understand the requirements of the study, including anonymous publication, and agree to co-operate with the study procedures.

Inclusion Criteria (Patients):

  • Diagnosed with Multiple Sclerosis.
  • Male or female volunteers who are between the ages of 21 and 80.
  • Able to give voluntary written informed consent to participate in the study.
  • Able to understand the requirements of the study, including anonymous publication, and agree to co-operate with the study procedures.

Exclusion Criteria:

  • Any history of neurological illness other than MS.
  • Known hypersensitivity to any MR or X-Ray contrast agent.
  • Any history of renal failure or disease.
  • Any history of allergies.
  • Any history of circulation problems (vascular disease).
  • Pregnancy or breastfeeding.
  • MRI contraindications as screened on safety questionnaire (e.g. metal implants or pacemaker).
  • Have taken part in any other clinical study within the previous 3 months.#
  • Any contraindications provided from MRI or contrast agent safety forms.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481882


Contacts
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Contact: Nikos Evangelou, Ph.D. 0115 970 9735 nikos.evangelou@nottingham.ac.uk
Contact: Penny A Gowland, Ph.D 0115 951 4754 penny.gowland@nottingham.ac.uk

Locations
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United Kingdom
Queen's Medical Centre Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG7 2RD
Contact: Nikos Evangelou    0115 9709735    nikos.evangelou@nottingham.ac.uk   
Contact: Yasser Falah    0115 924 9924    yasser.falah@nottingham.ac.uk   
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Nikos Evangelou, Ph.D. Faculty of Medicine & Health Sciences

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02481882     History of Changes
Other Study ID Numbers: 15037
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases