Brief Title
A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese Patients
Official Title
A Multicentre, Phase 3, Clinical Study to Compare the Striatal Uptake of a Dopamine Transporter Radioligand, DaTSCAN™ Ioflupane (123I) Injection, After Intravenous Administration to Chinese Patients With a Diagnosis of Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, or Essential Tremor and to Healthy Controls
Brief Summary
This is a multicentre, comparator-group, open-label, controlled, nonrandomised clinical study
to compare the SPECT findings after a single IV administration of DaTSCAN™ ioflupane (123I)
injection for patients with a clinical diagnosis of PS (SDD; specifically, patients with PD
[SDD], MSA [SDD] or PSP [SDD]) as compared with patients with a clinical diagnosis of ET (no
SDD) and age-matched healthy controls.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
• Assessment of DaTSCAN™ SPECT images by 3 independent blinded readers to compare specific striatal uptake with the clinical diagnosis.
Secondary Outcome
• Central read (by semi-quantitative assessment by use of DaTQUANT™) of DaTSCANTM SPECT images to compare specific uptake with clinical diagnosis.
Condition
Parkinsonian Syndrome
Intervention
DaTSCAN™ Ioflupane (123I) Injection
Study Arms / Comparison Groups
DaTSCAN™ ioflupane (123I) injection
Description: Participants will receive a single intravenous (IV) injection of DaTSCAN™ (123I) ioflupane. Single photon emission computed tomography (SPECT) imaging will be performed between 3 to 6 hours post-injection and will last approximately 20 minutes to 1 hour.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
172
Start Date
June 18, 2020
Completion Date
December 16, 2021
Primary Completion Date
December 16, 2021
Eligibility Criteria
Inclusion Criteria:
For all subjects:
1. Chinese male or female, aged 40 to 80 years, has agreed to sign and date the written
informed consent form.
For Healthy Volunteers:
2. Non-patient volunteers with good age-appropriate health as established by clinical
examination during screening and no evidence of movement disorder by complete
neurological evaluation.
For patients with Parkinson's disease:
3. A diagnosis of clinically established or clinically probable PD in accordance with the
MDS Clinical Diagnostic Criteria for Parkinson's Disease [Postuma et al. 2015].
For patients with MSA (SDD):
4. A diagnosis of probable or possible MSA in accordance with the Second Consensus
Statement on the Diagnosis of MSA [Gilman et al. 2008].
For patients with PSP (SDD):
5. A diagnosis of probable or possible PSP in accordance with the Clinical Criteria for
the Diagnosis of Progressive Supranuclear Palsy National Institute for Neurological
Disorders and Society for PSP (NINDS-SPSP) [Litvan et al. 1996].
For patients with ET (no SDD):
6. A diagnosis of definite or probable ET in accordance with the Washington
Heights-Inwood Genetic Study of Essential Tremor (WHIGET) diagnostic criteria for ET
(no SDD) [Louis et al. 1997].
Exclusion Criteria:
1. The subject is lactating.
2. The subject is pregnant as detected by a β-human chorionic gonadotropin (β-hCG)
pregnancy test.
3. A cerebral structural vascular abnormality indicative of at least 1 infarction in the
region of the basal ganglia (including the internal capsule) ≥5 mm has been confirmed,
preferably by magnetic resonance imaging (MRI) performed within 6 months of screening.
If an MRI is not clinically feasible, cerebral CT imaging within 6 months is also
acceptable.
4. The subject is diagnosed with major neurocognitive disorder by the Diagnostic and
Statistical Manual of Mental Disorders (DSM) 5 criteria, or Mini-Mental State
Examination total score is <24.
5. Subject is being investigated for or has been diagnosed and/or is being treated for
repeated stroke with stepwise progression of Parkinson features.
6. History of repeated head injury (≥3 concussions, or history of professional sports
with repeated head trauma [e.g., boxing]).
7. History of definite encephalitis (≥1 episode of confirmed encephalitis with objective
residual neurologic deficit).
8. The subject is using or has insufficient washout from medication known or suspected to
interact with striatal uptake through direct competition with binding of DaTSCAN™ to
the dopamine transporters (i.e., amphetamine, benztropine, bupropion, cocaine,
mazindol, methylphenidate, phentermine, sertraline, selective serotonin reuptake
inhibitors) before the imaging visit.
9. The patient is using Chinese traditional medicine for PD treatment, which cannot be
safely withdrawn for at least 1 week (7 days) before the imaging visit.
10. The subject has a moderate to severe renal impairment (e.g., serum creatinine >1.5x
upper limit of normal [ULN], blood urea nitrogen [BUN] >30 mg/dL).
11. The subject has a moderate to severe hepatic impairment (bilirubin >2x ULN and alanine
aminotransferase (ALT) or aspartate aminotransferase (AST)>3x ULN).
12. The subject has a history of current abuse of drugs and/or alcohol (for the previous
12 months before trial enrolment).
13. The subject has a history of occupational exposure to any radiation >50 mSv/year.
14. The subject has been previously enrolled in this study or participated in a clinical
study involving an investigational pharmaceutical product within 30 days prior to
screening and/or any radiopharmaceutical within a minimum of 5 radioactive half-lives
prior to screening.
15. The subject presents with symptoms suggestive of corticobasal degeneration or
Huntington's disease.
16. The subject has known allergies to the investigational medicinal product (IMP).
17. The subject presents with any clinically active, serious, life-threatening disease
with a life expectancy of less than 12 months.
18. Any laboratory value(s) exceeding the limits of normality if deemed to be clinically
relevant by the investigator.
19. The subject complains of claustrophobia.
20. The subject has a moderate to severe thyroid disease (thyroid stimulating hormone
[TSH] exceeding the limits of normality by more than 10%), if deemed to be clinically
relevant by the investigator.
For patients with ET:
21. The patient has at least 1 first-degree relative diagnosed with PD.
For Healthy Volunteers:
22. History of psychiatric illness.
For all subjects:
23. It is the physician's best judgment not to include the patient in the trial.
Gender
All
Ages
40 Years - 80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04193527
Organization ID
GE-001-024
Secondary IDs
CTR20191992
Responsible Party
Sponsor
Study Sponsor
GE Healthcare
Collaborators
PPD
Study Sponsor
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Verification Date
June 2022