Parkinson's DiseasePhase 3FPCITNCT00468078
Efficacy and Safety of F-18 FPCIT PET in Parkinson's Disease and Essential Tremor Patients
A Phase 3 study testing PET/CT and F-18 FPCIT in people with Parkinson's Disease, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether F-18 FPCIT is effective and safe radiopharmaceutical for the objective diagnosis of Parkinson's disease. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- PET/CT and F-18 FPCIT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2006to Oct 2007
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parkinson's disease
- Male or female with age over 40 years
- Clinical diagnosis of Parkinson's disease
- Ability to give informed consent
- Essential tremor
- Male or female with age over 40 years
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- Clinical diagnosis of Essential tremor
- Ability to give informed consent
- Healthy volunteers
- Male or female with age over 40 years
- No any symptoms or sign suggesting Parkinson's disease or essential tremor
- Ability to give informed consent
Who cannot join
- Parkinson's disease and essential tremor
- Current pregnancy and breast feeding
- Current or past medical history of cardiac and neuropsychiatric disease
- Clinical evidence of dementia
- Inability to hold antiparkinsonian medication
- History of surgical therapy for tremor
Show all 15Show fewer
- Severe or unstable medical or psychiatric condition
- Medication affecting CNS in last 6 months(e.g. CNS stimulants, sympathomimetics)
- Prior participation in other research protocol within 30 days
- Healthy volunteers
- Current pregnancy and breast feeding
- Current or past medical history of cardiac and neuropsychiatric disease
- Severe or unstable medical or psychiatric condition
- Drug abuse or medication affecting CNS (e.g. CNS stimulants, sympathomimetics) within 6 months
- Prior participation in other research protocol within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Single Center, Phase III Clinical Trial to Evaluate the Efficacy and the Safety of [18F]FPCIT Positron Emission Tomography in Parkinson's Disease and Essential Tremor Patients
The purpose of this study is to determine whether F-18 FPCIT is effective and safe radiopharmaceutical for the objective diagnosis of Parkinson's disease.
Read the detailed description
Parkinson's disease is a common neurodegenerative disorder with loss of dopaminergic terminals in the striatum. Essential tremor is one of the conditions most commonly misdiagnosed as parkinsonism, and early clinical differentiation between these conditions can be difficult. F-18 FPCIT is a promising radiopharmaceutical for PET imaging to assess the dopamine transporter in the striatum.
- Conditions
- Parkinson's Disease
- Being tested
- PET/CT, F-18 FPCIT
- Keywords
- Parkinson's disease, Essential tremor, F-18 FPCIT, PET
- Medical subject headings
- Parkinson Disease, Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTProcedure or surgery
Also called Positron Emission Tomography
10min acquisition, 90min after injection of F-18 FPCIT
F-18 FPCITDrug
5mCi, intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Parkinson's disease Receives: Procedure: PET/CT; Drug: F-18 FPCIT |
| B | Active comparator | ET+Normal Receives: Procedure: PET/CT; Drug: F-18 FPCIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic sensitivity and specificity, and acute complication
Measured: 1 month
Secondary outcomes (1)
correlation of specific striatal uptake to non specific uptake ratio of F-18 FPCIT and clinical sererity (H&Y stage)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2007 (estimated)
- Study startNov 2006
- Primary completionSep 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Seung Kim, Asan Medical Center
- Investigators
- Jae Seung Kim, MD, Principal investigator, Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468078
- Sponsor's protocol ID
- FPCITKR001
- Acronym
- FPCIT
- Status last verified
- Jan 2016
- First submitted
- 30 Apr 2007
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kazumata K, Dhawan V, Chaly T, Antonini A, Margouleff C, Belakhlef A, Neumeyer J, Eidelberg D. Dopamine transporter imaging with fluorine-18-FPCIT and PET. J Nucl Med. 1998 Sep;39(9):1521-30.
PubMed 9744335
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Single Center, Phase III Clinical Trial to Evaluate the Efficacy and the Safety of [18F]FPCIT Positron Emission Tomography in Parkinson's Disease and Essential Tremor Patients
- ClinicalTrials.gov ID
- NCT00468078
- Acronym / sponsor ID
- FPCIT / FPCITKR001
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Essential tremor, F-18 FPCIT, PET
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 1 May 2007 (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 purpose of this study is to determine whether F-18 FPCIT is effective and safe radiopharmaceutical for the objective diagnosis of Parkinson's disease.
Detailed description
Parkinson's disease is a common neurodegenerative disorder with loss of dopaminergic terminals in the striatum. Essential tremor is one of the conditions most commonly misdiagnosed as parkinsonism, and early clinical differentiation between these conditions can be difficult. F-18 FPCIT is a promising radiopharmaceutical for PET imaging to assess the dopamine transporter in the striatum.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: PET/CT, Drug: F-18 FPCITParkinson's disease |
| B | Active comparator | Procedure: PET/CT, Drug: F-18 FPCITET+Normal |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Parkinson's disease
- Male or female with age over 40 years
- Clinical diagnosis of Parkinson's disease
- Ability to give informed consent
- Essential tremor
Key exclusion criteria (15 listed)
- Parkinson's disease and essential tremor
- Current pregnancy and breast feeding
- Current or past medical history of cardiac and neuropsychiatric disease
- Clinical evidence of dementia
- Inability to hold antiparkinsonian medication
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/CTAlso: Positron Emission Tomography10min acquisition, 90min after injection of F-18 FPCIT | Procedure or surgery | A, B |
| F-18 FPCIT5mCi, intravenous injection | Drug | A, B |
Primary outcome
diagnostic sensitivity and specificity, and acute complication
Time frame: 1 month
1 secondary outcome
correlation of specific striatal uptake to non specific uptake ratio of F-18 FPCIT and clinical sererity (H&Y stage)
Time frame: 10 days
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 Jan 2016.
- Background: PubMed 9744335Kazumata K, Dhawan V, Chaly T, Antonini A, Margouleff C, Belakhlef A, Neumeyer J, Eidelberg D. Dopamine transporter imaging with fluorine-18-FPCIT and PET. J Nucl Med. 1998 Sep;39(9):1521-30.
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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.
Jae Seung Kim, MD principal investigator
Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PET/CT and F-18 FPCIT in people with Parkinson's Disease, run by Asan Medical Center at 1 site in South Korea.
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 12 inclusion and 15 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 Jan 2016. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
diagnostic sensitivity and specificity, and acute complication (time frame: 1 month). 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 NCT00468078, which also lists 1 linked publication.
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 Jan 2016.