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

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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

September 2022

Primary Completion Date

March 2022

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

, +86 21 38774044, [email protected]

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

, , 


Verification Date

June 2021