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Parkinsonian SyndromePhase 3NCT04193527

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

A Phase 3 study testing DaTSCAN™ Ioflupane (123I) Injection in people with Parkinsonian Syndrome and Parkinson Disease(PD), run by GE Healthcare at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 80 yearsHealthy volunteers can take part
What is being tested?
DaTSCAN™ Ioflupane (123I) Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
10 sitesChina
Study dates
28 Jun 2020to 20 Dec 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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) .

Who cannot join

  • 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]).
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  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Chaoyang District, 100029

  • Peking Union Medical College Hospital

    Beijing, Dongcheng District, 100730

  • Peking University First Hospital

    Beijing, 100034

  • Beijing Friendship Hospital Afflication to Capital Medical University

    Beijing, 100050

  • Nanfang Hospital, Nanfang Medical Univeristy

    Guangdong, Guangzhou

  • Shanghai General Hospital

    Hongkou, Shanghai Municipality, 200080

  • Nanjing First Hospital

    Nanjing, Jiangsu, 2100029

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200025

  • The Second Affilicated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

  • Tianjin Medical University General Hospital

    Tianjin, 300052

Other trials in China

About this study

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

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.

Being tested
DaTSCAN™ Ioflupane (123I) Injection
Medical subject headings
Parkinsonian Disorders, Parkinson Disease, Multiple System Atrophy, Supranuclear Palsy, Progressive, Essential Tremor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaTSCAN™ Ioflupane (123I) InjectionDrug

    Also called Ioflupane (123I)

    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.

Study groups in NCT04193527
Study groupRoleWhat they receive
DaTSCAN™ ioflupane (123I) injectionExperimentalParticipants 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.
Receives: Drug: DaTSCAN™ Ioflupane (123I) Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At Day 1

  2. 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.

    Measured: At Day 1

Secondary outcomes (2)

  1. 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™.

    Measured: At Day 1

  2. 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.

    Measured: From start of study drug administration up to Day 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2019
  2. Study start28 Jun 2020
  3. Primary completion20 Dec 2021
  4. Study completion20 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04193527
Sponsor's protocol ID
GE-001-024
Other IDs
CTR20191992
Status last verified
Dec 2022
First submitted
2 Dec 2019
Last updated
16 Oct 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DaTSCAN™ Ioflupane (123I) Injection in people with Parkinsonian Syndrome and Parkinson Disease(PD), run by GE Healthcare at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images (time frame: At Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04193527.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.

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