Parkinson DiseaseN3iPDNCT03022357
Nigrosomal Iron Imaging in Parkinson's Disease
An observational study of Parkinson Disease, run by University of Nottingham at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Patient assessment, DATScan and Orbital X-Ray
- Type of treatment
- Surgery or procedure
- How many people
- 145 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jun 2016to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Royal Derby Hospital
Derby, Derbyshire, DE22 3NE
Rob Skelly, 01332 340131, rob.skelly@nhs.net
- Not yet recruiting
Imperial College London
London, SW7 2AZ
Antonio M Batisda, +44 (0)20 7589 5111, a.martin-bastida@imperial.ac.uk
- Recruiting
University of Nottingham
Nottingham, NG7 2RD
Dorothee Auer, dorothee.auer@nottingham.ac.uk
Stefan Schwarz, stefan.schwarz@nottingham.ac.uk
About this study
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.
Read the detailed description
Idiopathic Parkinson's is characterized by loss of midbrain dopaminergic neurons preferentially affecting the nigrosomes of the pars compacta of the substantia nigra (SNpc). At the time of clinical diagnosis, an estimated 50-70% of the neurons of the SNpc are lost. Non-invasive imaging of cell loss in the nigrosomes containing the SNpc dopaminergic neurons would be clinically desirable for accurate diagnosis in clinically uncertain cases of parkinsonism, especially in the early stages of Parkinson's. Investigators recently discovered that high resolution susceptibility weighted MRI at 7T and 3T demonstrates iron related signal loss of the NS1 in Parkinson's. These studies proved the feasibility and potential of in vivo nigrosome MRI as new diagnostic tool for Parkinson's. Further support of and confidence in our novel diagnostic concept comes from similar observations by other research groups.
Project goals To establish whether nigrosome MRI is an alternative to DatScanTM in the diagnosis of early Parkinson's in patients with diagnostic uncertainty.
To establish whether nigrosomal iron predicts the severity of Parkinson's. As a secondary aim the investigators will study if nigrosomal iron load as determined by susceptometry correlates to disease severity (MDS-UPDRS).
TRIAL / STUDY OBJECTIVES AND PURPOSE
PURPOSE
- To establish whether nigrosome MRI is an alternative to DatScan in the diagnosis of early Parkinson's
- To establish whether nigrosomal iron predicts the severity of Parkinson's.
PRIMARY OBJECTIVE Validation of NS1 MRI as a qualitative diagnostic marker in early Parkinson's
- To investigate whether the presence or absence of the swallow tail on nigrosome MRI at 3T is as accurate as DatScan and at least 80% sensitive and 80% specific to predict the final clinical diagnosis of Parkinson's vs. other movement disorder in patients with indeterminate or atypical parkinsonian features.
Hypothesis 1: That the swallow tail sign is an accurate marker of early Parkinson's
SECONDARY OBJECTIVES Biomarker discovery based on quantitative nigrosome iron markers in Parkinson's • To investigate whether diagnostic performance of nigrosome MRI can be further improved through quantitative assessment of nigrosomal iron and combination with neuromelanin metrics.
Hypothesis 2: That nigrosomal iron metrics further improve the detection of early Parkinson's
- To assess how well disease severity can be predicted by iron content in the nigrosome and by a combination of iron content and the size of the neuromelanin-rich nigra volume.
Hypothesis 3: That nigrosomal iron metrics are closely associated with severity of early Parkinson's
The investigators will be recruiting 145 patients with diagnostic uncertainty of Parkinson's Disease. These patients will undergo a MRI and DATscans and will be clinically examined. They will then be followed-up (clinical examination) in 12 months, identifying if they can be confirmed as having Parkinson's Disease, in order to compare the sensitivity and specificity of nigrosome1 detected by MRI with DATScan, potentially allowing a non-invasive and much less expensive means of diagnosing Parkinson's Disease.
- Conditions
- Parkinson Disease
- Being tested
- Patient assessment, DATScan, Orbital X-Ray, Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startJun 2016
- Primary completionApr 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Dorothee Auer (Principal Investigator), Principal investigator, University of NottinghamStefan Schwarz (Co-Principal Investigator), Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022357
- Sponsor's protocol ID
- 16048
- Acronym
- N3iPD
- Status last verified
- Jan 2017
- First submitted
- 4 Jan 2017
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24710392Blazejewska 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.
PubMed 23843466Cosottini 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.
PubMed 25376811Reiter 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.
PubMed 25773707Schuff 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.
PubMed 19877239Piccini 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.
PubMed 15099543Hughes 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.
PubMed 1564476Hughes 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.
PubMed 11912118Rajput 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.
PubMed 1913360Pirker 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.
PubMed 11104200Fearnley 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.
PubMed 1933245Cosottini 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.
PubMed 24601752Kwon 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.
PubMed 22367998Damier 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.
PubMed 10430829Damier 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.
PubMed 10430830
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nigrosomal Iron Imaging in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03022357
- Acronym / sponsor ID
- N3iPD / 16048
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, National Institute for Health Research, United Kingdom
- Study start
- Jun 2016
- Primary completion
- Apr 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Idiopathic Parkinson's is characterized by loss of midbrain dopaminergic neurons preferentially affecting the nigrosomes of the pars compacta of the substantia nigra (SNpc). At the time of clinical diagnosis, an estimated 50-70% of the neurons of the SNpc are lost. Non-invasive imaging of cell loss in the nigrosomes containing the SNpc dopaminergic neurons would be clinically desirable for accurate diagnosis in clinically uncertain cases of parkinsonism, especially in the early stages of Parkinson's. Investigators recently discovered that high resolution susceptibility weighted MRI at 7T and 3T demonstrates iron related signal loss of the NS1 in Parkinson's. These studies proved the feasibility and potential of in vivo nigrosome MRI as new diagnostic tool for Parkinson's. Further support of and confidence in our novel diagnostic concept comes from similar observations by other research groups.
Project goals To establish whether nigrosome MRI is an alternative to DatScanTM in the diagnosis of early Parkinson's in patients with diagnostic uncertainty.
To establish whether nigrosomal iron predicts the severity of Parkinson's. As a secondary aim the investigators will study if nigrosomal iron load as determined by susceptometry correlates to disease severity (MDS-UPDRS).
TRIAL / STUDY OBJECTIVES AND PURPOSE
PURPOSE
- To establish whether nigrosome MRI is an alternative to DatScan in the diagnosis of early Parkinson's
- To establish whether nigrosomal iron predicts the severity of Parkinson's.
PRIMARY OBJECTIVE Validation of NS1 MRI as a qualitative diagnostic marker in early Parkinson's
- To investigate whether the presence or absence of the swallow tail on nigrosome MRI at 3T is as accurate as DatScan and at least 80% sensitive and 80% specific to predict the final clinical diagnosis of Parkinson's vs. other movement disorder in patients with indeterminate or atypical parkinsonian features.
Hypothesis 1: That the swallow tail sign is an accurate marker of early Parkinson's
SECONDARY OBJECTIVES Biomarker discovery based on quantitative nigrosome iron markers in Parkinson's • To investigate whether diagnostic performance of nigrosome MRI can be further improved through quantitative assessment of nigrosomal iron and combination with neuromelanin metrics.
Hypothesis 2: That nigrosomal iron metrics further improve the detection of early Parkinson's
- To assess how well disease severity can be predicted by iron content in the nigrosome and by a combination of iron content and the size of the neuromelanin-rich nigra volume.
Hypothesis 3: That nigrosomal iron metrics are closely associated with severity of early Parkinson's
The investigators will be recruiting 145 patients with diagnostic uncertainty of Parkinson's Disease. These patients will undergo a MRI and DATscans and will be clinically examined. They will then be followed-up (clinical examination) in 12 months, identifying if they can be confirmed as having Parkinson's Disease, in order to compare the sensitivity and specificity of nigrosome1 detected by MRI with DATScan, potentially allowing a non-invasive and much less expensive means of diagnosing Parkinson's Disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (12 listed)
- Participants with any known contraindication to MRI such as:
- (only for those planned for research DatScan) Participants in which a DatScan nuclear medical study can't be performed due to
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient assessmentClinical examination, Examination, Questionnaires | Other | – |
| DATScanIn small subgroup | Radiation | – |
| Orbital X-RayIf foreign body in eye needs exclusion | Radiation | – |
| Magnetic Resonance Imaging (MRI)MRI scanning of all subjects | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Background: PubMed 24710392Schwarz 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.
- Background: PubMed 23843466Blazejewska 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.
- Background: PubMed 25376811Cosottini 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.
- Background: PubMed 25773707Reiter 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.
- Background: PubMed 19877239Schuff 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.
- Background: PubMed 15099543Piccini 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.
- Background: PubMed 1564476Hughes 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.
- Background: PubMed 11912118Hughes 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.
- Background: PubMed 1913360Rajput 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.
- Background: PubMed 11104200Pirker 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.
- Background: PubMed 1933245Fearnley 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.
- Background: PubMed 24601752Cosottini 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.
- NICE Guideline (UK). Diagnosing Parkinson's disease. 2006 \[cited 2015 Jul 31\]Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorothee Auer (Principal Investigator) principal investigator
University of Nottingham
Stefan Schwarz (Co-Principal Investigator) principal investigator
University of Nottingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University of Nottingham at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorothee Auer (01158 231178, dorothee.auer@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of "swallow tail" on nigrosome MRI at 3T (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03022357, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.