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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

Primary Purpose

Parkinsonian Syndrome, Parkinson Disease(PD), Multiple System Atrophy (MSA)

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
DaTSCAN™ Ioflupane (123I) Injection
Sponsored by
GE Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinsonian Syndrome

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Beijing Anzhen Hospital, Capital Medical University
  • Peking Union Medical College Hospital
  • Nanfang Hospital, Nanfang Medical Univeristy
  • Nanjing First Hospital
  • The Second Affilicated Hospital of Soochow University
  • Shanghai General Hospital
  • Peking University First Hospital
  • Beijing Friendship Hospital Afflication to Capital Medical University
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  • Tianjin Medical University General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DaTSCAN™ ioflupane (123I) injection

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images
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 was performed with DaTQUANT™.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious TEAEs
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this investigational product (IP) or medicinal product. A Serious Adverse Event(SAE) was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE was any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. Number of participants with TEAEs and serious TEAEs were reported.

Full Information

First Posted
December 2, 2019
Last Updated
December 14, 2022
Sponsor
GE Healthcare
Collaborators
PPD
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1. Study Identification

Unique Protocol Identification Number
NCT04193527
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 28, 2020 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare
Collaborators
PPD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinsonian Syndrome, Parkinson Disease(PD), Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP), Essential Tremor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DaTSCAN™ ioflupane (123I) injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
DaTSCAN™ Ioflupane (123I) Injection
Other Intervention Name(s)
Ioflupane (123I)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images
Description
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.
Time Frame
At Day 1
Title
Specificity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images
Description
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.
Time Frame
At Day 1
Secondary Outcome Measure Information:
Title
Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images
Description
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 was performed with DaTQUANT™.
Time Frame
At Day 1
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious TEAEs
Description
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this investigational product (IP) or medicinal product. A Serious Adverse Event(SAE) was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE was any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. Number of participants with TEAEs and serious TEAEs were reported.
Time Frame
From start of study drug administration up to Day 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) . Exclusion Criteria: 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. The participant has known allergies to the investigational medicinal product (IMP). The participant presents with any clinically active, serious, life-threatening disease with a life expectancy of less than 12 months. Any laboratory value(s) exceeding the limits of normality if deemed to be clinically relevant by the investigator. The participant complains of claustrophobia. 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 clinically relevant by the investigator. For participants with ET: The participant has at least 1 first-degree relative diagnosed with PD. For Healthy Volunteers: History of psychiatric illness. For all participants: It is the physician's best judgment not to include the participant in the trial.
Facility Information:
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
State/Province
Chaoyang District
ZIP/Postal Code
100029
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Dongcheng District
ZIP/Postal Code
100730
Country
China
Facility Name
Nanfang Hospital, Nanfang Medical Univeristy
City
Guangdong
State/Province
Guangzhou
Country
China
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
2100029
Country
China
Facility Name
The Second Affilicated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Name
Shanghai General Hospital
City
Hongkou
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Friendship Hospital Afflication to Capital Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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