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

NCT04193527 | Completed Phase 3 Results

• 2 other identifiers: GE-001-024CTR20191992
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Parkinsonian Syndrome; Parkinson Disease(PD); Multiple System Atrophy (MSA); Progressive Supranuclear Palsy (PSP); Essential Tremor

Outcome Measures

Primary Outcomes (2)

• Sensitivity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images

  Sensitivity was defined as positive percentage agreement and calculated as the number of true positives (TP) / (number of TP + number of false negatives \[FN\]): TP/(TP + FN), and a 2-sided 95% binomial confidence interval constructed around it. Only the participants with a clinical diagnosis of PS were included in the sensitivity analysis. The sensitivity 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 was used as the standard of truth, were summarized with by reader. Each participant's SPECT image was read by 3 blinded readers.

  At Day 1

• Specificity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images

  Specificity was defined as negative percentage agreement and calculated as the number of true negatives (TN) / (number of TN + number of false positives \[FP\]): TN/(TN + FP), and a 2-sided 95% binomial confidence interval constructed around it. For the specificity analysis, only participants with a clinical diagnosis of ET were included; the HVs were excluded from this analysis. The 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 was used as the standard of truth, were summarized with by reader. Each participant's SPECT image was read by 3 blinded readers.

  At Day 1

Secondary Outcomes (2)

• Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images

  At Day 1

• Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious TEAEs

  From start of study drug administration up to Day 4

Study Arms (1)

DaTSCAN™ ioflupane (123I) injection

EXPERIMENTAL

Participants with Parkinsonian Syndrome (PS), Essential Tremor (ET), and Healthy Volunteers (HV) received a single dose of DaTSCAN™ ioflupane (123I) injection. Single photon emission computed tomography (SPECT) imaging was performed between 3 to 6 hours post-injection and lasted approximately 20 minutes to 1 hour.

Drug: DaTSCAN™ Ioflupane (123I) Injection

Interventions

DaTSCAN™ Ioflupane (123I) Injection DRUG

All participants (Participants with PS, ET, and HV) received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 megabecquerel (MBq) (3 to 5 millicurie \[mCi\]) per participant at a maximum volume of 5 milliliter \[mL\]) intravenously on Day 1.

Also known as: Ioflupane (123I)

DaTSCAN™ ioflupane (123I) injection

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For all participants:
• Chinese male or female, aged 40 to 80 years, has agreed to sign and date the written informed consent form.
• For Healthy Volunteers:
• 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 participants with Parkinson's disease:
• A diagnosis of clinically established or clinically probable PD in accordance with the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease.
• For participants with MSA (SDD):
• A diagnosis of probable or possible MSA in accordance with the Second Consensus Statement on the Diagnosis of MSA.
• For participants with PSP (SDD):
• 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)
• For participants with ET (no SDD):
• 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) .

You may not qualify if:

• The participant is lactating.
• The participant is pregnant as detected by a β-human chorionic gonadotropin (β-hCG) pregnancy test.
• 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.
• The participant 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.
• Participant is being investigated for or has been diagnosed and/or is being treated for repeated stroke with stepwise progression of Parkinson features.
• History of repeated head injury (≥3 concussions, or history of professional sports with repeated head trauma \[e.g., boxing\]).
• History of definite encephalitis (≥1 episode of confirmed encephalitis with objective residual neurologic deficit).
• The participant 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.
• The participant is using Chinese traditional medicine for PD treatment, which cannot be safely withdrawn for at least 1 week (7 days) before the imaging visit.
• 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).
• The participant has a moderate to severe hepatic impairment (bilirubin \>2x ULN and alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\>3x ULN).
• The participant has a history of current abuse of drugs and/or alcohol (for the previous 12 months before trial enrolment).
• The participant has a history of occupational exposure to any radiation \>50 millisievert/year (mSv/year).
• The participant 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.
• The participant presents with symptoms suggestive of corticobasal degeneration or Huntington's disease.

Sponsors & Collaborators

• GE Healthcare: lead
• PPD Development, LP: collaborator

Study Sites (10)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Chaoyang District, 100029, China

Location

Peking Union Medical College Hospital

Beijing, Dongcheng District, 100730, China

Location

Nanfang Hospital, Nanfang Medical Univeristy

Guangdong, Guangzhou, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, 2100029, China

Location

The Second Affilicated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

Location

Shanghai General Hospital

Hongkou, Shanghai Municipality, 200080, China

Location

Peking University First Hospital

Beijing, 100034, China

Location

Beijing Friendship Hospital Afflication to Capital Medical University

Beijing, 100050, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

Location

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

MeSH Terms

Conditions

Parkinsonian Disorders; Parkinson Disease; Multiple System Atrophy; Supranuclear Palsy, Progressive; Essential Tremor

Interventions

Iodine-123; Injections; ioflupane

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Yongqing Tang, MD, PhD
• Organization: GE Healthcare Ltd.

Yongqing.Tang@ge.com

21 38774044

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 10, 2019
• Study Start: June 28, 2020
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: October 16, 2023
• Results First Posted: October 16, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)