Parkinson's DiseasePhase 2NCT01824056
The Differential Diagnosis of Parkinson's Disease and Parkinsonism by Positron-emission Tomography
A Phase 2 study testing 18F-FDG in people with Parkinson's Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The objective of this protocol is to analyze the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of Parkinson's disease (PD) and other parkinsonism disorders, including multiple system atrophy (MSA), corticobasal degeneration (CBD), and progressive supranuclear palsy (PSP). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- 18F-FDG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2010to Jul 2013
- Phase
- Phase 2
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Forty subjects with a diagnosis of PD whom must:
- i.Male or female patients, age range 20~80. ii.Patients should be fulfilled Criteria of diagnosis of Parkinson disease8 of "possible" or "probable" PD (Appendix I).
- iii.Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).
- Forty subjects with a diagnosis of MSA whom must:
- i.Male or female patients, age range 20~80. ii.Patients should be fulfilled the Consensus diagnostic criteria of "possible" or "probable" MSA14 (Appendix II).
- Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).
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- Twenty subjects with a diagnosis of PSP whom must:
- i.Male or female patients, age range 20~80. ii.Patients should be fulfilled the NINDS-SPSP clinical criteria for the diagnosis of PSP of "possible" or "probable" PSP35 (Appendix III).
- iii.Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).
- Twenty subjects with a diagnosis of CBD whom must:
- i.Male or female patients, age range 20~80. ii.Patients should be fulfilled the Kumar's criteria of CBD36 (Appendix IV). iii.Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).
Who cannot join
- Pregnant or becoming pregnant during the study or current breast feeding.
- Any subject who has a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.
- i.Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances.
- ii.Current clinically significant cardiovascular disease. (cardiac surgery or myocardial infarction within the last 6 months; unstable angina; decompensated congestive heart failure; significant cardiac arrhythmia; congenital heart disease.
- History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.
- History or presence of QTc prolongation.
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- History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
- Any documented abnormality in the brain by CT or MRI of brain, which might contribute to the motor function, such as hydrocephalus, multiple infarction and encephalomalacia, will be excluded. Mild cortical atrophy and non-specific white matter changes will be allowed.
- Patients who have the evidence of secondary parkinsonism (multiple infarcts, intoxication, and hydrocephalus, etc) or other neurodegenerative diseases, such as spinocerebellar atrophy (SCA), Wilson's disease, hydrocephalus, multiple infarction, serious head injury and definite history of neurotoxin exposure, are excluded.
- General PET exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Differential Diagnosis of Parkinson's Disease and Parkinsonism by Positron-emission Tomography With Vesicular Monoamine Transporter Ligand (18F-DTBZ)
The objective of this protocol is to analyze the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of Parkinson's disease (PD) and other parkinsonism disorders, including multiple system atrophy (MSA), corticobasal degeneration (CBD), and progressive supranuclear palsy (PSP).
Read the detailed description
40 patients with PD, 40 patients with MSA, 20 patients with CBD, and 20 patients with PSP, will be enrolled. Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, each subject will have 3 visits in this study, as one screening visit, one imaging visit, and one safety evaluation visit.
Safety measurement will be evaluated by medical history, vital signs, physical examinations,
- Conditions
- Parkinson's Disease
- Being tested
- 18F-FDG
- Keywords
- 18F-FDG
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDGDrug
During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-DTBZ immediately prior to imaging.
The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG.
| Study group | Role | What they receive |
|---|---|---|
| 18F-DTBZ for Parkinson's Disease | Experimental | This study will compare the brain uptake of 18F- DTBZ in 40 patients with PD, 40 patients with MSA, 20 patients with CBD, and 20 patients with PSP . Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, each subject will have 3 visits in this study. Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events. Receives: Drug: 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
To analyze the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of PD ,PSP,MSA,CBD.
All subjects that received 18F-FP-(+)-DTBZ for injection.Sensitivity and specificity analysis of VMAT2 imaging will include all subjects for whom there is sufficient data to evaluate the parameter in question.Descriptive statistics will be presented to help detect changes within groups or differences between groups (PD vs. MSA, CBD, PSP). The descriptive statistics will include mean, standard deviation, median, and ranges for continuous variables, and frequency and percent frequency for categorical variables.Mann Whitney test will be used to compare the mean SUVR values between PD and other groups. ROC curve will be used to determinate the diagnostic threshold of SUVR and the sensitivity and specificity of 18F- DTBZ PET in the differentiating PD, MSA, PSP, and CBD. Statistical analysis was performed using a unpaired t test based on one contrast to test a hypothesis of regional abnormal uptakes of 18F-DTBZ in an individual MSA/PSP/CBD patient compared to a PD group.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startAug 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, NJI90OKM, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824056
- Sponsor's protocol ID
- 98-3626A
- Status last verified
- Nov 2013
- First submitted
- 12 Mar 2013
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Differential Diagnosis of Parkinson's Disease and Parkinsonism by Positron-emission Tomography With Vesicular Monoamine Transporter Ligand (18F-DTBZ)
- ClinicalTrials.gov ID
- NCT01824056
- Acronym / sponsor ID
- 98-3626A
- Conditions
- Parkinson's Disease
- Keywords
- 18F-FDG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Apr 2013 (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.
The objective of this protocol is to analyze the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of Parkinson's disease (PD) and other parkinsonism disorders, including multiple system atrophy (MSA), corticobasal degeneration (CBD), and progressive supranuclear palsy (PSP).
Detailed description
40 patients with PD, 40 patients with MSA, 20 patients with CBD, and 20 patients with PSP, will be enrolled. Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, each subject will have 3 visits in this study, as one screening visit, one imaging visit, and one safety evaluation visit.
Safety measurement will be evaluated by medical history, vital signs, physical examinations,
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-DTBZ for Parkinson's Disease | Experimental | Drug: 18F-FDGThis study will compare the brain uptake of 18F- DTBZ in 40 patients with PD, 40 patients with MSA, 20 patients with CBD, and 20 patients with PSP . Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, each subject will have 3 visits in this study. Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Forty subjects with a diagnosis of PD whom must:
- i.Male or female patients, age range 20~80. ii.Patients should be fulfilled Criteria of diagnosis of Parkinson disease8 of "possible" or "probable" PD (Appendix I).
- iii.Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).
- Forty subjects with a diagnosis of MSA whom must:
- i.Male or female patients, age range 20~80. ii.Patients should be fulfilled the Consensus diagnostic criteria of "possible" or "probable" MSA14 (Appendix II).
Key exclusion criteria (10 listed)
- Pregnant or becoming pregnant during the study or current breast feeding.
- Any subject who has a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.
- i.Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances.
- ii.Current clinically significant cardiovascular disease. (cardiac surgery or myocardial infarction within the last 6 months; unstable angina; decompensated congestive heart failure; significant cardiac arrhythmia; congenital heart disease.
- History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.
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 |
|---|---|---|
| 18F-FDGDuring this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-DTBZ immediately prior to imaging. The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG. | Drug | 18F-DTBZ for Parkinson's Disease |
Primary outcome
To analyze the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of PD ,PSP,MSA,CBD.
Time frame: 3 years
All subjects that received 18F-FP-(+)-DTBZ for injection.Sensitivity and specificity analysis of VMAT2 imaging will include all subjects for whom there is sufficient data to evaluate the parameter in question.Descriptive statistics will be presented to help detect changes within groups or differences between groups (PD vs. MSA, CBD, PSP). The descriptive statistics will include mean, standard deviation, median, and ranges for continuous variables, and frequency and percent frequency for categorical variables.Mann Whitney test will be used to compare the mean SUVR values between PD and other groups. ROC curve will be used to determinate the diagnostic threshold of SUVR and the sensitivity and specificity of 18F- DTBZ PET in the differentiating PD, MSA, PSP, and CBD. Statistical analysis was performed using a unpaired t test based on one contrast to test a hypothesis of regional abnormal uptakes of 18F-DTBZ in an individual MSA/PSP/CBD patient compared to a PD group.
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 13 Nov 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-FDG in people with Parkinson's Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 11 inclusion and 10 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 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To analyze the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of PD ,PSP,MSA,CBD. (time frame: 3 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 13 Nov 2013.