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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|ClinicalTrials.gov Identifier: NCT04193527|
Recruitment Status : Completed
First Posted : December 10, 2019
Last Update Posted : June 22, 2022
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|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||172 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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)
- • 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.
- • 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™.
- • 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||40 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
For all subjects:
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 patients with Parkinson's disease:
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):
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):
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):
- 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].
- The subject is lactating.
- The subject 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 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.
- Subject 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 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.
- 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.
- 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).
- The subject has a moderate to severe hepatic impairment (bilirubin >2x ULN and alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>3x ULN).
- The subject has a history of current abuse of drugs and/or alcohol (for the previous 12 months before trial enrolment).
- The subject has a history of occupational exposure to any radiation >50 mSv/year.
- 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.
- The subject presents with symptoms suggestive of corticobasal degeneration or Huntington's disease.
- The subject has known allergies to the investigational medicinal product (IMP).
- The subject 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 subject complains of claustrophobia.
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:
The patient has at least 1 first-degree relative diagnosed with PD.
For Healthy Volunteers:
History of psychiatric illness.
For all subjects:
- It is the physician's best judgment not to include the patient in the trial.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193527
|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|
|Nanfang Hospital, Nanfang Medical Univeristy|
|Guangdong, Guangzhou, China|
|Nanjing First Hospital|
|Nanjing, Jiangsu, China, 2100029|
|The Second Affilicated Hospital of Soochow University|
|Suzhou, Jiangsu, China, 215004|
|Shanghai General Hospital|
|Hongkou, Shanghai, China, 200080|
|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|
|Responsible Party:||GE Healthcare|
|Other Study ID Numbers:||
CTR20191992 ( Registry Identifier: China Drug Evalutation )
|First Posted:||December 10, 2019 Key Record Dates|
|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|
Multiple System Atrophy
Supranuclear Palsy, Progressive
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathological Conditions, Anatomical
Autonomic Nervous System Diseases
Ocular Motility Disorders
Cranial Nerve Diseases