Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DaTSCAN Ioflupane · 2 trials · 6 indications
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 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.
An AE was defined as any untoward medical occurrence in participants or clinical investigation participant which did not necessarily have to have been related to the investigational medical product (IMP). AEs were recorded from time of informed consent through the follow-up visit at 2 weeks (±2 days) after IMP administration.
Tolerability questionnaire evaluated participants mood, pain at injection site, itchiness of injection site, loss of function at injection site and quality of sleep using 100 millimeter (mm) VAS. VAS is a continuous scale comprised of a horizontal line, usually 100 mm in length, where "0" stands for bad, and 100 mm stands for good. Higher score indicated better health outcomes.
Physical examination included recording an assessment for the presence of abnormalities of the following: general appearance, skin, lungs, cardiovascular system, back and spine, abdomen, extremities, lymph nodes, and neurological exam. Clinical significance was determined by investigator.
Change from baseline in activated partial thromboplastin time, prothrombin time, thrombin time were reported.
Change from baseline in C reactive protein were reported.
Change from baseline in hematocrit were reported.
Change from baseline in erythrocytes were reported.
Change from baseline in leukocytes, platelets timepoints were reported.
Change from baseline in fibrinogen, hemoglobin were reported.
Change from baseline in albumin, protein were reported.
Change from baseline in thyroxine, free and triiodothyronine, free were reported.
Change from baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase, gamma glutamyl transferase, lactate dehydrogenase were reported.
Change from baseline in thyroxine and triiodothyronine were reported.
Change from baseline in bilirubin, creatinine, direct bilirubin, and urate were reported.
Change from baseline in bicarbonate, calcium, chloride, glucose, phosphate, potassium, sodium, urea nitrogen were reported.
Change from baseline in thyrotropin were reported.
Change from baseline in amylase were reported.
Number of participants with clinically significant abnormal pH and specific gravity were reported. Clinical significance was determined by investigator.
Any radiopharmaceutical extravasation, bleeding, hematoma, redness, infection, or other findings were considered as abnormal findings.
Change from baseline in systolic blood pressure were reported.
Change from baseline in diastolic blood pressure were reported.
Change from baseline in heart rate were reported.
Change from baseline in temperature were reported.
Change from baseline in respiratory rate were reported.
Change from baseline in oxygen saturation were reported.
Change from baseline in PR interval, QRS interval, QT interval, QTC interval, RR interval, QTCF interval, QTCB interval were reported.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: For all participants: 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 an...
DaTSCAN Ioflupane is a small molecule diagnostic agent used in single photon emission computed tomography (SPECT) imaging to evaluate patients with suspected Parkinsonian syndrome. It helps in the diagnosis of conditions such as Parkinson disease, multiple system atrophy, progressive supranuclear palsy, and essential tremor. It has been studied in Chinese patients for diagnostic efficacy.
DaTSCAN Ioflupane targets the dopamine transporter in the brain. It is a radiopharmaceutical that binds to dopamine transporters, allowing visualization of dopaminergic neurons via SPECT imaging. This helps differentiate Parkinsonian syndromes from other conditions like essential tremor by assessing the integrity of the dopaminergic system.
DaTSCAN Ioflupane is developed by GE HealthCare Technologies Inc., a company publicly traded under the ticker GEHC. The company is conducting clinical studies to evaluate the diagnostic efficacy and safety of this product in various patient populations.
DaTSCAN Ioflupane is in Phase 1 clinical development, based on a completed Phase 1 study in healthy volunteers. However, it has also been evaluated in a completed Phase 3 study for diagnostic efficacy in patients with Parkinsonian syndrome. The drug is investigational and not yet approved for use.
DaTSCAN Ioflupane has been studied in two completed clinical trials. NCT04193527 was a Phase 3 study evaluating diagnostic efficacy in Chinese patients with Parkinsonian syndrome, enrolling 172 participants. NCT04564092 was a Phase 1 study assessing safety and biodistribution in healthy volunteers, enrolling 9 participants.
DaTSCAN Ioflupane is a brand name for the radiopharmaceutical ioflupane, which is also known as ioflupane (123I). The product is administered as an injection for SPECT imaging to evaluate dopamine transporter levels in the brain, aiding in the diagnosis of Parkinsonian syndromes.