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

Last updated: December 14, 2022
Sponsor: GE Healthcare
Overall Status: Completed

Phase

3

Condition

Multiple System Atrophy

Progressive Supranuclear Palsy

Dyskinesias

Treatment

DaTSCAN™ Ioflupane (123I) Injection

Clinical Study ID

NCT04193527
GE-001-024
CTR20191992
  • Ages 40-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a multicenter, open-label, non-controlled, non-randomized, phase 3 clinical study to compare the SPECT findings after a single IV administration of DaTSCAN™ ioflupane (123I) injection for patients with a clinical diagnosis of Parkinsonian syndrome (PS) involving striatal dopaminergic deficit (SDD; specifically, Parkinson's disease [PD] [SDD], multiple system atrophy [MSA] [SDD] or or progressive supranuclear palsy [PSP] [SDD]) as compared with patients with a clinical diagnosis of essential tremor (ET) (no SDD) and age-matched healthy controls.

Eligibility Criteria

Inclusion

Inclusion Criteria: For all participants:

  1. Chinese male or female, aged 40 to 80 years, has agreed to sign and date the writteninformed consent form. For Healthy Volunteers:
  2. Non-patient volunteers with good age-appropriate health as established by clinicalexamination during screening and no evidence of movement disorder by completeneurological evaluation. For participants with Parkinson's disease:
  3. A diagnosis of clinically established or clinically probable PD in accordance with theMovement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease. For participants with MSA (SDD):
  4. A diagnosis of probable or possible MSA in accordance with the Second ConsensusStatement on the Diagnosis of MSA. For participants with PSP (SDD):
  5. A diagnosis of probable or possible PSP in accordance with the Clinical Criteria forthe Diagnosis of Progressive Supranuclear Palsy National Institute for NeurologicalDisorders and Society for PSP (NINDS-SPSP) For participants with ET (no SDD):
  6. A diagnosis of definite or probable ET in accordance with the WashingtonHeights-Inwood Genetic Study of Essential Tremor (WHIGET) diagnostic criteria for ET (no SDD) .

Exclusion

Exclusion Criteria:

  1. The participant is lactating.
  2. The participant 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 theregion 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 alsoacceptable.
  4. The participant is diagnosed with major neurocognitive disorder by the Diagnostic andStatistical Manual of Mental Disorders (DSM) 5 criteria, or Mini-Mental StateExamination total score is <24.
  5. Participant is being investigated for or has been diagnosed and/or is being treatedfor repeated stroke with stepwise progression of Parkinson features.
  6. History of repeated head injury (≥3 concussions, or history of professional sportswith repeated head trauma [e.g., boxing]).
  7. History of definite encephalitis (≥1 episode of confirmed encephalitis with objectiveresidual neurologic deficit).
  8. The participant is using or has insufficient washout from medication known orsuspected to interact with striatal uptake through direct competition with binding ofDaTSCAN™ to the dopamine transporters (i.e., amphetamine, benztropine, bupropion,cocaine, mazindol, methylphenidate, phentermine, sertraline, selective serotoninreuptake inhibitors) before the imaging visit.
  9. The participant is using Chinese traditional medicine for PD treatment, which cannotbe safely withdrawn for at least 1 week (7 days) before the imaging visit.
  10. The participant 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 participant has a moderate to severe hepatic impairment (bilirubin >2x ULN andalanine aminotransferase (ALT) or aspartate aminotransferase (AST)>3x ULN).
  12. The participant has a history of current abuse of drugs and/or alcohol (for theprevious 12 months before trial enrolment).
  13. The participant has a history of occupational exposure to any radiation >50millisievert/year (mSv/year).
  14. The participant has been previously enrolled in this study or participated in aclinical study involving an investigational pharmaceutical product within 30 daysprior to screening and/or any radiopharmaceutical within a minimum of 5 radioactivehalf-lives prior to screening.
  15. The participant presents with symptoms suggestive of corticobasal degeneration orHuntington's disease.
  16. The participant has known allergies to the investigational medicinal product (IMP).
  17. The participant presents with any clinically active, serious, life-threatening diseasewith a life expectancy of less than 12 months.
  18. Any laboratory value(s) exceeding the limits of normality if deemed to be clinicallyrelevant by the investigator.
  19. The participant complains of claustrophobia.
  20. The participant has a moderate to severe thyroid disease (thyroid stimulating hormone [TSH] exceeding the limits of normality by more than 10%), if deemed to be clinicallyrelevant by the investigator. For participants with ET:
  21. The participant has at least 1 first-degree relative diagnosed with PD. For Healthy Volunteers:
  22. History of psychiatric illness. For all participants:
  23. It is the physician's best judgment not to include the participant in the trial.

Study Design

Total Participants: 172
Treatment Group(s): 1
Primary Treatment: DaTSCAN™ Ioflupane (123I) Injection
Phase: 3
Study Start date:
June 28, 2020
Estimated Completion Date:
December 20, 2021

Connect with a study center

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Chaoyang District 100029
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, Dongcheng District 100730
    China

    Site Not Available

  • Nanfang Hospital, Nanfang Medical Univeristy

    Guangdong, Guangzhou
    China

    Site Not Available

  • Nanjing First Hospital

    Nanjing, Jiangsu 2100029
    China

    Site Not Available

  • The Second Affilicated Hospital of Soochow University

    Suzhou, Jiangsu 215004
    China

    Site Not Available

  • Shanghai General Hospital

    Hongkou, Shanghai 200080
    China

    Site Not Available

  • Beijing Friendship Hospital Afflication to Capital Medical University

    Beijing, 100050
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, 100034
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200025
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, 300052
    China

    Site Not Available

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