Nigrosomal Iron Imaging in Parkinson's Disease (N3iPD)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Parkinson Disease | Other: Patient assessment Radiation: DATScan Radiation: Orbital X-Ray Other: Magnetic Resonance Imaging (MRI) |

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 |

- 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
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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

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
Contact: Dorothee Auer | 01158 231178 | dorothee.auer@nottingham.ac.uk | |
Contact: Stefan Schwarz | 029 2074 7747 | stefan.schwarz@nottingham.ac.uk |
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 |
Principal Investigator: | Dorothee Auer (Principal Investigator) | University of Nottingham | |
Principal Investigator: | Stefan Schwarz (Co-Principal Investigator) | University of Nottingham |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |