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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04193527|
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : February 8, 2021
|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)|
|Estimated 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|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||September 2022|
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.
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
|Contact: Quan Hu, PhD||+86 21 firstname.lastname@example.org|
|Contact: Tingting Wang||+86 1519 5789918||Tingting.email@example.com|
|China, Chaoyang District|
|Beijing Anzhen Hospital, Capital Medical University||Not yet recruiting|
|Beijing, Chaoyang District, China, 100029|
|Contact: LIU Guangzhi 13391777952 Guangzhl2002@hotmail.com|
|China, Dongcheng District|
|Peking Union Medical College Hospital||Not yet recruiting|
|Beijing, Dongcheng District, China, 100730|
|Contact: WAN Xinhua 13021099528 firstname.lastname@example.org|
|Nanfang Hospital, Nanfang Medical Univeristy||Not yet recruiting|
|Guangdong, Guangzhou, China|
|Contact: XU Yunqi 13751838377 email@example.com|
|The Second Affilicated Hospital of Soochow University||Not yet recruiting|
|Suzhou, Jiangsu, China, 215004|
|Contact: LIU Chunfeng 0512-267783307 firstname.lastname@example.org|
|Peking University First Hospital||Recruiting|
|Beijing, China, 100034|
|Contact: HUANG Yining 01083572857 email@example.com|
|Beijing Friendship Hospital Afflication to Capital Medical University||Recruiting|
|Beijing, China, 100050|
|Contact: TUO Houzhen 13683628005 firstname.lastname@example.org|
|Ruijin Hospital, Shanghai Jiaotong University School of Medicine||Recruiting|
|Shanghai, China, 200025|
|Contact: CHEN Shengdi 13818018166 email@example.com|
|Tianjin Medical University General Hospital||Recruiting|
|Tianjin, China, 300052|
|Contact: TAN Jian 13821192491 firstname.lastname@example.org|