NCT03022357

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

October 12, 2018

Status Verified

January 1, 2017

Enrollment Period

2.8 years

First QC Date

January 4, 2017

Last Update Submit

October 11, 2018

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Presence or absence of "swallow tail" on nigrosome MRI at 3T

    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.

    12 months

Interventions

Patient assessmentOTHER

Clinical examination, Examination, Questionnaires

DATScanRADIATION

In small subgroup

Orbital X-RayRADIATION

If foreign body in eye needs exclusion

Magnetic Resonance Imaging (MRI)OTHER

MRI scanning of all subjects

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

NOT YET RECRUITING

Imperial College London

London, SW7 2AZ, United Kingdom

NOT YET RECRUITING

University of Nottingham

Nottingham, NG7 2RD, United Kingdom

RECRUITING

Related Publications (20)

  • Schwarz ST, Afzal M, Morgan PS, Bajaj N, Gowland PA, Auer DP. The 'swallow tail' appearance of the healthy nigrosome - a new accurate test of Parkinson's disease: a case-control and retrospective cross-sectional MRI study at 3T. PLoS One. 2014 Apr 7;9(4):e93814. doi: 10.1371/journal.pone.0093814. eCollection 2014.

    PMID: 24710392BACKGROUND

  • Blazejewska AI, Schwarz ST, Pitiot A, Stephenson MC, Lowe J, Bajaj N, Bowtell RW, Auer DP, Gowland PA. Visualization of nigrosome 1 and its loss in PD: pathoanatomical correlation and in vivo 7 T MRI. Neurology. 2013 Aug 6;81(6):534-40. doi: 10.1212/WNL.0b013e31829e6fd2. Epub 2013 Jul 10.

    PMID: 23843466BACKGROUND

  • Cosottini M, Frosini D, Pesaresi I, Donatelli G, Cecchi P, Costagli M, Biagi L, Ceravolo R, Bonuccelli U, Tosetti M. Comparison of 3T and 7T susceptibility-weighted angiography of the substantia nigra in diagnosing Parkinson disease. AJNR Am J Neuroradiol. 2015 Mar;36(3):461-6. doi: 10.3174/ajnr.A4158. Epub 2014 Nov 6.

    PMID: 25376811BACKGROUND

  • Reiter E, Mueller C, Pinter B, Krismer F, Scherfler C, Esterhammer R, Kremser C, Schocke M, Wenning GK, Poewe W, Seppi K. Dorsolateral nigral hyperintensity on 3.0T susceptibility-weighted imaging in neurodegenerative Parkinsonism. Mov Disord. 2015 Jul;30(8):1068-76. doi: 10.1002/mds.26171. Epub 2015 Mar 15.

    PMID: 25773707BACKGROUND

  • Schuff N. Potential role of high-field MRI for studies in Parkinson's disease. Mov Disord. 2009;24 Suppl 2:S684-90. doi: 10.1002/mds.22647.

    PMID: 19877239BACKGROUND

  • Piccini P, Whone A. Functional brain imaging in the differential diagnosis of Parkinson's disease. Lancet Neurol. 2004 May;3(5):284-90. doi: 10.1016/S1474-4422(04)00736-7.

    PMID: 15099543BACKGROUND

  • Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry. 1992 Mar;55(3):181-4. doi: 10.1136/jnnp.55.3.181.

    PMID: 1564476BACKGROUND

  • Hughes AJ, Daniel SE, Ben-Shlomo Y, Lees AJ. The accuracy of diagnosis of parkinsonian syndromes in a specialist movement disorder service. Brain. 2002 Apr;125(Pt 4):861-70. doi: 10.1093/brain/awf080.

    PMID: 11912118BACKGROUND

  • Rajput AH, Rozdilsky B, Rajput A. Accuracy of clinical diagnosis in parkinsonism--a prospective study. Can J Neurol Sci. 1991 Aug;18(3):275-8. doi: 10.1017/s0317167100031814.

    PMID: 1913360BACKGROUND

  • Pirker W, Asenbaum S, Bencsits G, Prayer D, Gerschlager W, Deecke L, Brucke T. [123I]beta-CIT SPECT in multiple system atrophy, progressive supranuclear palsy, and corticobasal degeneration. Mov Disord. 2000 Nov;15(6):1158-67. doi: 10.1002/1531-8257(200011)15:63.0.co;2-0.

    PMID: 11104200BACKGROUND

  • Fearnley JM, Lees AJ. Ageing and Parkinson's disease: substantia nigra regional selectivity. Brain. 1991 Oct;114 ( Pt 5):2283-301. doi: 10.1093/brain/114.5.2283.

    PMID: 1933245BACKGROUND

  • Cosottini M, Frosini D, Pesaresi I, Costagli M, Biagi L, Ceravolo R, Bonuccelli U, Tosetti M. MR imaging of the substantia nigra at 7 T enables diagnosis of Parkinson disease. Radiology. 2014 Jun;271(3):831-8. doi: 10.1148/radiol.14131448. Epub 2014 Feb 26.

    PMID: 24601752BACKGROUND

  • Kwon DH, Kim JM, Oh SH, Jeong HJ, Park SY, Oh ES, Chi JG, Kim YB, Jeon BS, Cho ZH. Seven-Tesla magnetic resonance images of the substantia nigra in Parkinson disease. Ann Neurol. 2012 Feb;71(2):267-77. doi: 10.1002/ana.22592.

    PMID: 22367998BACKGROUND

  • Damier P, Hirsch EC, Agid Y, Graybiel AM. The substantia nigra of the human brain. I. Nigrosomes and the nigral matrix, a compartmental organization based on calbindin D(28K) immunohistochemistry. Brain. 1999 Aug;122 ( Pt 8):1421-36. doi: 10.1093/brain/122.8.1421.

    PMID: 10430829BACKGROUND

  • Damier P, Hirsch EC, Agid Y, Graybiel AM. The substantia nigra of the human brain. II. Patterns of loss of dopamine-containing neurons in Parkinson's disease. Brain. 1999 Aug;122 ( Pt 8):1437-48. doi: 10.1093/brain/122.8.1437.

    PMID: 10430830BACKGROUND

  • Baudrexel S, Nurnberger L, Rub U, Seifried C, Klein JC, Deller T, Steinmetz H, Deichmann R, Hilker R. Quantitative mapping of T1 and T2* discloses nigral and brainstem pathology in early Parkinson's disease. Neuroimage. 2010 Jun;51(2):512-20. doi: 10.1016/j.neuroimage.2010.03.005. Epub 2010 Mar 6.

    PMID: 20211271BACKGROUND

  • Wallis LI, Paley MN, Graham JM, Grunewald RA, Wignall EL, Joy HM, Griffiths PD. MRI assessment of basal ganglia iron deposition in Parkinson's disease. J Magn Reson Imaging. 2008 Nov;28(5):1061-7. doi: 10.1002/jmri.21563.

    PMID: 18972346BACKGROUND

  • Zhang W, Sun SG, Jiang YH, Qiao X, Sun X, Wu Y. Determination of brain iron content in patients with Parkinson's disease using magnetic susceptibility imaging. Neurosci Bull. 2009 Dec;25(6):353-60. doi: 10.1007/s12264-009-0225-8.

    PMID: 19927171BACKGROUND

  • Beam CA. Strategies for improving power in diagnostic radiology research. AJR Am J Roentgenol. 1992 Sep;159(3):631-7. doi: 10.2214/ajr.159.3.1503041.

    PMID: 1503041BACKGROUND

  • Schwarz ST, Xing Y, Naidu S, Birchall J, Skelly R, Perkins A, Evans J, Sare G, Martin-Bastida A, Bajaj N, Gowland P, Piccini P, Auer DP. Protocol of a single group prospective observational study on the diagnostic value of 3T susceptibility weighted MRI of nigrosome-1 in patients with parkinsonian symptoms: the N3iPD study (nigrosomal iron imaging in Parkinson's disease). BMJ Open. 2017 Dec 14;7(12):e016904. doi: 10.1136/bmjopen-2017-016904.

    PMID: 29247084DERIVED

Related Links

MeSH Terms

Conditions

Parkinson Disease

Interventions

Patient Outcome AssessmentioflupaneMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and EvaluationSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Dorothee Auer (Principal Investigator)

    University of Nottingham

    PRINCIPAL INVESTIGATOR

  • Stefan Schwarz (Co-Principal Investigator)

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorothee Auer

CONTACT

01158 231178dorothee.auer@nottingham.ac.uk

Stefan Schwarz

CONTACT

029 2074 7747stefan.schwarz@nottingham.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 16, 2017

Study Start

June 1, 2016

Primary Completion

April 1, 2019

Study Completion

May 1, 2019

Last Updated

October 12, 2018

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(3)