ParkinsonNCT02495649
Evaluation of Myocardial Sympathetic Denervation in Parkinson's Disease Using [18F]FDOPA
A study testing [18F]-DOPA and PET-CT in people with Parkinson, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate the added value of PET-CT with [18F]FDOPA tracer for Assessment of the Myocardial Sympathetic Denervation in patients with or suspected with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson
- What is being tested?
- [18F]-DOPA and PET-CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2015to Jul 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Signed Informed Consent
- Patients referred for F-dopa scan of basal ganglia in the evaluation of Parkinson's disease or other extra pyramidal motor disorders.
- Patients diagnosed with Parkinson's disease.
Who cannot join
- Age < 18
- Previous diagnosed Heart Disease.
- History of High blood pressure.
- On medications that influence the sympathetic system.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sourasky Medical Center
Tel Aviv
ira korovin, 036974373, irako@tlvmc.gov.il
About this study
The purpose of this study is to evaluate the added value of PET-CT with [18F]FDOPA tracer for Assessment of the Myocardial Sympathetic Denervation in patients with or suspected with Parkinson's disease.
The investigators expect to see normal values of uptake ratio of [18F]FDOPA , in patients with no synuclein underline pathology or previously known cardiovascular disease (no history of high blood pressure or take medications that influence the sympathetic system- exclusion criteria). Low values of uptake ratio is presumed to be found in patients diagnosed with Parkinson's disease or other synuclein pathology.
The expected normal ratio of Heart/liver uptake values will be determined from scans of patients refered to [18F]FDOPA scan and were found to have normal [18F]FDOPA scan of the basal ganglia and no cardiovascular diseases.
Read the detailed description
L-3,4-dihydroxy-6-[18F]fluoro-phenylalanine ([18F]FDOPA) might be a useful tracer for assessing myocardial sympathetic denervation in Parkinson's disease (PD) Patients. Compared to the routinely used I123 MIBG scan, [18F]FDOPA seems to have an advantage for the following reasons:
- meta-iodobenzylguanidine (MIBG) is a false analog of norepinephrine while [18F]FDOPA is the radiolabelled form of DOPA, a direct precursor of dopamine which is subsequently converted to norepinephrine
- 123I MIBG, un-like norepinephrine, dose not undergo intracellular metabolism (19) while [18F]FDOPA undergo complex intracellular metabolism (17)
- Studies have shown that I123 MIBG reuptake is almost exclusive by uptake mechanism 1. Uptake-2 mechanism of 123I-MIBG by the myocardium is not significant. Reuptake of norepinephrine (NE) in the synaptic cleft and is mainly by uptake 1 system but also in small amount by uptake 2 systems. The investigators assumption is that this double mechanism of reuptake will increase the concentration of [18F]FDOPA for better imaging
- Conditions
- Parkinson
- Being tested
- [18F]-DOPA, PET-CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-DOPAOther
To evaluate the feasibility of PET-CT with [18F]-DOPA to assess the myocardial sympathetic denervation in patients with or suspected with Parkinson's disease
PET-CTDevice
To evaluate the feasibility of PET-CT with [18F]-DOPA to assess the myocardial sympathetic denervation in patients with or suspected with Parkinson's disease
| Study group | Role | What they receive |
|---|---|---|
| [18F]-DOPA | Other | evaluate the added value of PET-CT with [18F]-DOPA tracer for Assessment of the Myocardial Sympathetic Denervation in patients with or suspected with Parkinson's disease. Receives: Other: [18F]-DOPA; Device: PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The uptake of [18F]FDOPA will be measured by the ratio between the uptake in the heart and the uptake in the liver.
The uptake value of [18F]FDOPA will be measured by the ratio of standard uptake value (SUV) in the heart and the SUV in the liver.
Normal uptake will be calculated by the mean uptake ratio in the healthy population (plus minus standard deviation) and used to compare to patients with abnormal [18F]FDOPA scan of the basal ganglia.
Measured: paitents will be scanned in PET- CT scaner for 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2015
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParkinsonStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
- Investigators
- Einat Even Sapir, Phd, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495649
- Sponsor's protocol ID
- TASMO-15-ES-0606-14-TLV-CTIL
- Status last verified
- Jan 2020
- First submitted
- 3 Jun 2015
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Myocardial Sympathetic Denervation in Parkinson's Disease Using [18F]FDOPA
- ClinicalTrials.gov ID
- NCT02495649
- Acronym / sponsor ID
- TASMO-15-ES-0606-14-TLV-CTIL
- Conditions
- Parkinson
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Aug 2015 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jul 2021 (estimated)
- First posted
- 13 Jul 2015 (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 evaluate the added value of PET-CT with [18F]FDOPA tracer for Assessment of the Myocardial Sympathetic Denervation in patients with or suspected with Parkinson's disease.
The investigators expect to see normal values of uptake ratio of [18F]FDOPA , in patients with no synuclein underline pathology or previously known cardiovascular disease (no history of high blood pressure or take medications that influence the sympathetic system- exclusion criteria). Low values of uptake ratio is presumed to be found in patients diagnosed with Parkinson's disease or other synuclein pathology.
The expected normal ratio of Heart/liver uptake values will be determined from scans of patients refered to [18F]FDOPA scan and were found to have normal [18F]FDOPA scan of the basal ganglia and no cardiovascular diseases.
Detailed description
L-3,4-dihydroxy-6-[18F]fluoro-phenylalanine ([18F]FDOPA) might be a useful tracer for assessing myocardial sympathetic denervation in Parkinson's disease (PD) Patients. Compared to the routinely used I123 MIBG scan, [18F]FDOPA seems to have an advantage for the following reasons:
- meta-iodobenzylguanidine (MIBG) is a false analog of norepinephrine while [18F]FDOPA is the radiolabelled form of DOPA, a direct precursor of dopamine which is subsequently converted to norepinephrine
- 123I MIBG, un-like norepinephrine, dose not undergo intracellular metabolism (19) while [18F]FDOPA undergo complex intracellular metabolism (17)
- Studies have shown that I123 MIBG reuptake is almost exclusive by uptake mechanism 1. Uptake-2 mechanism of 123I-MIBG by the myocardium is not significant. Reuptake of norepinephrine (NE) in the synaptic cleft and is mainly by uptake 1 system but also in small amount by uptake 2 systems. The investigators assumption is that this double mechanism of reuptake will increase the concentration of [18F]FDOPA for better imaging
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]-DOPA | Other | Other: [18F]-DOPA, Device: PET-CTevaluate the added value of PET-CT with [18F]-DOPA tracer for Assessment of the Myocardial Sympathetic Denervation in patients with or suspected with Parkinson's disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- Signed Informed Consent
- Patients referred for F-dopa scan of basal ganglia in the evaluation of Parkinson's disease or other extra pyramidal motor disorders.
- Patients diagnosed with Parkinson's disease.
Key exclusion criteria (4 listed)
- Age < 18
- Previous diagnosed Heart Disease.
- History of High blood pressure.
- On medications that influence the sympathetic system.
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]-DOPATo evaluate the feasibility of PET-CT with [18F]-DOPA to assess the myocardial sympathetic denervation in patients with or suspected with Parkinson's disease | Other | [18F]-DOPA |
| PET-CTTo evaluate the feasibility of PET-CT with [18F]-DOPA to assess the myocardial sympathetic denervation in patients with or suspected with Parkinson's disease | Device | [18F]-DOPA |
Primary outcome
The uptake of [18F]FDOPA will be measured by the ratio between the uptake in the heart and the uptake in the liver.
Time frame: paitents will be scanned in PET- CT scaner for 10 minutes
The uptake value of [18F]FDOPA will be measured by the ratio of standard uptake value (SUV) in the heart and the SUV in the liver. Normal uptake will be calculated by the mean uptake ratio in the healthy population (plus minus standard deviation) and used to compare to patients with abnormal [18F]FDOPA scan of the basal ganglia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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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.
Einat Even Sapir, Phd, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]-DOPA and PET-CT in people with Parkinson, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 4 inclusion and 4 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 18 Jan 2020. 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 Israel. 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 Adi Feiner, B.sc (03-6974373, advar@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The uptake of [18F]FDOPA will be measured by the ratio between the uptake in the heart and the uptake in the liver. (time frame: paitents will be scanned in PET- CT scaner for 10 minutes). 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 18 Jan 2020.