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

• ClinicalTrials.gov Identifier: NCT04193527
• Recruitment Status: Completed
• First Posted: December 10, 2019
• Last Update Posted: June 22, 2022
• Sponsor: GE Healthcare
• Collaborator: PPD
• Information provided by (Responsible Party): GE Healthcare

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parkinsonian Syndrome; Parkinson Disease(PD); Multiple System Atrophy (MSA); Progressive Supranuclear Palsy (PSP)	Drug: DaTSCAN™ Ioflupane (123I) Injection	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 172 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: June 18, 2020
• Actual Primary Completion Date: December 16, 2021
• Actual Study Completion Date: December 16, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: DaTSCAN™ ioflupane (123I) injection; 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.	Drug: DaTSCAN™ Ioflupane (123I) Injection; All participants will receive a single IV injection of DaTSCAN™ ioflupane (123I) into an arm vein. The dose of DaTSCAN™ ioflupane (123I) administered will contain a total of 3 to 5 mCi (111 to 185 MBq) in a maximum volume of 5 mL for an individual participant.; Other Name: Ioflupane (123I)

Outcome Measures

Primary Outcome Measures :

1. • Assessment of DaTSCAN™ SPECT images by 3 independent blinded readers to compare specific striatal uptake with the clinical diagnosis. [ Time Frame: 1 Day ]
   The sensitivity and specificity of the Blinded independent read of DaTSCAN™ SPECT images in detecting or excluding striatal dopaminergic deficit (SDD), when the clinical diagnosis as established by the investigator is used as the standard of truth, will be summarised with both by-reader and majority-read analyses.

Secondary Outcome Measures :

1. • Central read (by semi-quantitative assessment by use of DaTQUANT™) of DaTSCANTM SPECT images to compare specific uptake with clinical diagnosis. [ Time Frame: 1 Day ]
   A semi-quantitative analysis of the striatal uptake ratios in specific regions of interest (ROIs; i.e., left and right striatum, caudate, and putamen) of DaTSCAN™ SPECT images will be performed with DaTQUANT™.
2. • Comparison and assessment of safety parameters and AEs reported by all study participants. [ Time Frame: 32 Days ]

   An overall summary of AEs and DaTSCAN™-emergent AEs will be presented, coded with Medical Dictionary for Regulatory Activities (MedDRA) and summarised by MedDRA system-organ class and preferred term.

   Observations and changes from baseline in the results of the physical examination (including vital signs blood pressure and heart rate), neurological examination, injection site monitoring, and clinical laboratory evaluations (haematology, serum biochemistry, and urinalysis) will be summarised.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

China, Chaoyang District

Beijing Anzhen Hospital, Capital Medical University

Beijing, Chaoyang District, China, 100029

China, Dongcheng District

Peking Union Medical College Hospital

Beijing, Dongcheng District, China, 100730

China, Guangzhou

Nanfang Hospital, Nanfang Medical Univeristy

Guangdong, Guangzhou, China

China, Jiangsu

Nanjing First Hospital

Nanjing, Jiangsu, China, 2100029

The Second Affilicated Hospital of Soochow University

Suzhou, Jiangsu, China, 215004

China, Shanghai

Shanghai General Hospital

Hongkou, Shanghai, China, 200080

China

Peking University First Hospital

Beijing, China, 100034

Beijing Friendship Hospital Afflication to Capital Medical University

Beijing, China, 100050

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China, 200025

Tianjin Medical University General Hospital

Tianjin, China, 300052

Sponsors and Collaborators

GE Healthcare

PPD

More Information

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT04193527
• Other Study ID Numbers: GE-001-024; CTR20191992 ( Registry Identifier: China Drug Evalutation )
• First Posted: December 10, 2019
• Last Update Posted: June 22, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Parkinson Disease; Multiple System Atrophy; Shy-Drager Syndrome; Supranuclear Palsy, Progressive; Parkinsonian Disorders; Syndrome; Atrophy; Disease; Pathologic Processes; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathological Conditions, Anatomical; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases