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Nigrosomal Iron Imaging in Parkinson's Disease (N3iPD)

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ClinicalTrials.gov Identifier: NCT03022357
Recruitment Status : Unknown
Verified January 2017 by University of Nottingham.
Recruitment status was:  Recruiting
First Posted : January 16, 2017
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
Michael J. Fox Foundation for Parkinson's Research
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Nottingham

Study Description
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Brief Summary:
Prospective observational study to compare sensitivity of 3T functional Magnetic Resonance Imaging (3T fMRI) at diagnosing Parkinson's Disease (PD) against the benchmark DaTScan diagnostic test and clinical diagnosis at follow up.

Condition or disease Intervention/treatment
Parkinson Disease Other: Patient assessment Radiation: DATScan Radiation: Orbital X-Ray Other: Magnetic Resonance Imaging (MRI)

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Study Design
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Study Type : Observational
Estimated Enrollment : 145 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nigrosomal Iron Imaging in Parkinson's Disease
Study Start Date : June 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : May 2019

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Groups and Cohorts
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Intervention Details:
  • Other: Patient assessment
    Clinical examination, Examination, Questionnaires
  • Radiation: DATScan
    In small subgroup
  • Radiation: Orbital X-Ray
    If foreign body in eye needs exclusion
  • Other: Magnetic Resonance Imaging (MRI)
    MRI scanning of all subjects

Outcome Measures
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Primary Outcome Measures :
  1. Presence or absence of "swallow tail" on nigrosome MRI at 3T [ Time Frame: 12 months ]
    Does absence of "swallow tail" on nigrosome MRI at 3T correlate with final diagnosis of Parkinson's Disease 12 months after initial presentation of clinically uncertain diagnosis? Is this correlation as accurate as that of DatScan? Is nigrosome MRI at 3T at least 80% sensitive and 80% specific to predict the final clinical diagnosis of Parkinson's disease vs. other movement disorders in patients with indeterminate or atypical parkinsonian features? Is the "swallow tail" and accurate marker of early Parkinson's disease.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All potential participants need to have to capacity to give consent prior to study enrolment. Study participation is not possible if the participant is unable to give consent or does not have the capacity to consent.
Criteria

Inclusion criteria:

  • Ability to give informed consent
  • Age > 21 to < 90 years

  • Clinical symptoms suspicious for a diagnosis of Parkinson's disease but clinical uncertainty with regards to a definite diagnosis:

    • Clinical symptoms not meeting all of the required UK brain bank diagnostic criteria for the diagnosis of PD
    • Clinical features not typically associated with PD and therefore raising the possibility of a different type disorder/movement disorder
  • Referred for a DatScan as part of the NHS clinical diagnostic workup to investigate a suspicion for a parkinsonian movement disorder type disease or referred for a research DatScan as part of this study for the diagnostic workup to investigate a suspicion for a parkinsonian movement disorder type disease.

Exclusion criteria:

  • Participants with any known contraindication to MRI such as:

    • Intracranial aneurysm clips
    • Cardiac pacemakers and defibrillators
    • Cochlear implants.
    • MR-incompatible metal implant or tattoo
    • Patients with a significant head tremor
    • Claustrophobia
    • Pregnant women
    • Participants that are felt to be unfit for the MRI scan according to the judgement of medically qualified personnel, either on the research team, or the patient's clinical team. (eg. due to back pain, claustrophobia, acute sickness etc.) This includes patients with signs of impaired temperature regulation such as an extremely high fever.

  • (only for those planned for research DatScan) Participants in which a DatScan nuclear medical study can't be performed due to

    • Severe allergy to iodide compounds
    • Thyroid gland dysfunction
Contacts and Locations
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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): NCT03022357


Contacts
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Contact: Dorothee Auer 01158 231178 dorothee.auer@nottingham.ac.uk
Contact: Stefan Schwarz 029 2074 7747 stefan.schwarz@nottingham.ac.uk

Locations
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United Kingdom
Royal Derby Hospital Not yet recruiting
Derby, Derbyshire, United Kingdom, DE22 3NE
Contact: Rob Skelly    01332 340131    rob.skelly@nhs.net   
Imperial College London Not yet recruiting
London, United Kingdom, SW7 2AZ
Contact: Antonio M Batisda    +44 (0)20 7589 5111    a.martin-bastida@imperial.ac.uk   
University of Nottingham Recruiting
Nottingham, United Kingdom, NG7 2RD
Contact: Dorothee Auer       dorothee.auer@nottingham.ac.uk   
Contact: Stefan Schwarz       stefan.schwarz@nottingham.ac.uk   
Sponsors and Collaborators
University of Nottingham
Michael J. Fox Foundation for Parkinson's Research
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Dorothee Auer (Principal Investigator) University of Nottingham
Principal Investigator: Stefan Schwarz (Co-Principal Investigator) University of Nottingham
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03022357    
Other Study ID Numbers: 16048
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases