Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as DaTSCAN™ Ioflupane (123I) Injection
DaTSCAN Ioflupane · 1 trial · 5 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.
| 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 used as a diagnostic imaging agent for Parkinsonian Syndrome. It is administered as an injection and used with single photon emission computed tomography, or SPECT, to help evaluate patients with suspected Parkinsonian Syndrome, including conditions such as Parkinson disease, multiple system atrophy, and progressive supranuclear palsy.
DaTSCAN Ioflupane is developed and manufactured by GE HealthCare Technologies Inc., which trades under the ticker GEHC. The product is marketed as DaTSCAN Ioflupane (123I) Injection.
DaTSCAN Ioflupane has been studied in a Phase 3 clinical trial. That trial, conducted in China, has been completed. The drug is an injectable diagnostic agent in the neurology therapeutic area.
DaTSCAN Ioflupane has been evaluated in the Phase 3 trial NCT04193527, titled a study to evaluate the diagnostic efficacy of DaTSCAN Ioflupane (123I) Injection in SPECT for the diagnosis of Parkinsonian Syndrome in Chinese patients. The trial enrolled 172 participants and is completed.
Yes, DaTSCAN Ioflupane and DaTSCAN Ioflupane (123I) Injection refer to the same product. The full name specifies the radioactive iodine-123 label used in the injectable formulation. Both names describe the diagnostic agent developed by GE HealthCare Technologies Inc. for Parkinsonian Syndrome imaging.