Parkinson DiseaseNCT06171451
Prognostic Values of PET Examination With 11 C-Fe_CIT With Voxel-based Analysis Method in Patients With Sporadic Parkonson's Disease and Parkinsonisms (Prot.PD-diagn).
An observational study of Parkinson Disease, run by IRCCS San Raffaele.
Trial summary
The role of PET for the in vivo study of the presynaptic dopaminergic system with 11C-Fe-CIT is universally recognized, and its use has also become routine in numerous nuclear medicine centers in Europe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- PET with 11C-Fe-CIT
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2008to 15 Jul 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected to be evaluated with 11C-Fe-CIT PET: Over the age of 18 years, with a diagnosis of initial PD or parkinsonism and at the time of the PET study, patients will express their written consent for the anonymous use of the data relating to their 11C-Fe-CIT' examination for scientific purposes.
Who may be able to join
- Diagnosed with initial PD or parkinsonism;
- signature of informed consent.
Who cannot join
- patients < 18 years
About this study
The role of PET for the in vivo study of the presynaptic dopaminergic system with 11C-Fe-CIT is universally recognized, and its use has also become routine in numerous nuclear medicine centers in Europe. The indication for the examination is provided exclusively by the clinic in the presence of extrapyramidal signs in the suspicion of Parkinson's disease (PD) or for the differential diagnosis of parkinsonisms. The existence of factors that influence the prognosis of patients with PD or parkinsonism associated with other degenerative diseases is known.
Given these premises, the possibility of identifying the disease in the early stages appears fundamental.
Read more
For this purpose the following should be considered:
- an automatic analysis method based on the measurement of radiotracer uptake at the level of individual voxels, following Statistical Parametric Mapping procedures.
- the analysis based on regions of interest (ROIs) positioned ad hoc by the operator which will give the value of the ROI to reference region ratio. In particular, ROIs on the basal ganglia (caudate, putamen) towards cerebellum.
Both of these methods offer a quantitative measurement of the damage at the level of the structures involved that is absolutely better than the visual investigation of the distribution of radioactivity in the central nervous system.
In this study the investigators want to compare results provided by methods 1 and 2 in the populations under examination to evaluate the data relating to the specificity and sensitivity of the test.
- Conditions
- Parkinson Disease
- Being tested
- PET with 11C-Fe-CIT
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET with 11C-Fe-CITDiagnostic test
Use of the PET11C-Fe_CIT method for the early diagnosis of Parkinson's and in the differential diagnosis between Parkinson's and parkinsonism.
What is being measured
The primary outcome is the main question the study is designed to answer.
PET11C-Fe_CIT method for the staging of patients with Parkinson.
All patients undergo to 11C Fe CIT PET examination and the data will be analyzed with ROI and SPM voxel based and correlated with neurological data.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start12 Oct 2008
- Primary completion15 Jul 2009
- Study completion15 Jul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiti Arturo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171451
- Sponsor's protocol ID
- PD-DIAHN/08
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Values of PET Examination With 11 C-Fe_CIT With Voxel-based Analysis Method in Patients With Sporadic Parkonson's Disease and Parkinsonisms (Prot.PD-diagn).
- ClinicalTrials.gov ID
- NCT06171451
- Acronym / sponsor ID
- PD-DIAHN/08
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 12 Oct 2008 (actual)
- Primary completion
- 15 Jul 2009 (actual)
- Study completion
- 15 Jul 2009 (actual)
- First posted
- 14 Dec 2023 (actual)
- 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.
The role of PET for the in vivo study of the presynaptic dopaminergic system with 11C-Fe-CIT is universally recognized, and its use has also become routine in numerous nuclear medicine centers in Europe. The indication for the examination is provided exclusively by the clinic in the presence of extrapyramidal signs in the suspicion of Parkinson's disease (PD) or for the differential diagnosis of parkinsonisms. The existence of factors that influence the prognosis of patients with PD or parkinsonism associated with other degenerative diseases is known.
Given these premises, the possibility of identifying the disease in the early stages appears fundamental.
For this purpose the following should be considered:
- an automatic analysis method based on the measurement of radiotracer uptake at the level of individual voxels, following Statistical Parametric Mapping procedures.
- the analysis based on regions of interest (ROIs) positioned ad hoc by the operator which will give the value of the ROI to reference region ratio. In particular, ROIs on the basal ganglia (caudate, putamen) towards cerebellum.
Both of these methods offer a quantitative measurement of the damage at the level of the structures involved that is absolutely better than the visual investigation of the distribution of radioactivity in the central nervous system.
In this study the investigators want to compare results provided by methods 1 and 2 in the populations under examination to evaluate the data relating to the specificity and sensitivity of the test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected to be evaluated with 11C-Fe-CIT PET: Over the age of 18 years, with a diagnosis of initial PD or parkinsonism and at the time of the PET study, patients will express their written consent for the anonymous use of the data relating to their 11C-Fe-CIT' examination for scientific purposes.
Key inclusion criteria (2 listed)
- Diagnosed with initial PD or parkinsonism;
- signature of informed consent.
Key exclusion criteria (1 listed)
- patients < 18 years
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 |
|---|---|---|
| PET with 11C-Fe-CITUse of the PET11C-Fe_CIT method for the early diagnosis of Parkinson's and in the differential diagnosis between Parkinson's and parkinsonism. | Diagnostic test | – |
Primary outcome
PET11C-Fe_CIT method for the staging of patients with Parkinson.
Time frame: 2 years
All patients undergo to 11C Fe CIT PET examination and the data will be analyzed with ROI and SPM voxel based and correlated with neurological data.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by IRCCS San Raffaele.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET11C-Fe_CIT method for the staging of patients with Parkinson. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2023.