NCT04193527 is a Phase 3 clinical trial of DaTSCAN™ Ioflupane (123I) Injection in Parkinsonian Syndrome, sponsored by GE Healthcare.

Who is sponsoring NCT04193527?

NCT04193527 is sponsored by GE Healthcare.

What drugs are being tested in NCT04193527?

Interventions in NCT04193527: DaTSCAN™ Ioflupane (123I) Injection.

What condition does NCT04193527 study?

NCT04193527 studies Parkinsonian Syndrome, Parkinson Disease(PD), Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP), Essential Tremor.

Is NCT04193527 still recruiting?

NCT04193527 is currently completed. Last updated 16 October 2023.

Are results published for NCT04193527?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-10-16 · How we verify

NCT04193527

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 16 October 2023

What this trial tests

Phase 3 trial testing DaTSCAN™ Ioflupane (123I) Injection in Parkinsonian Syndrome in 172 participants. Completed in 20 December 2021.

Timeline

28 June 2020

Primary endpoint
20 December 2021

20 December 2021

Quick facts

Lead sponsor	GE Healthcare
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	172
Start date	28 June 2020
Primary completion	20 December 2021
Estimated completion	20 December 2021
Sites	10 locations across China

Drugs / interventions tested

DaTSCAN™ Ioflupane (123I) Injection — full drug profile →

Conditions studied

Parkinsonian Syndrome — all drugs for Parkinsonian Syndrome →
Parkinson Disease(PD) — all drugs for Parkinson Disease(PD) →
Multiple System Atrophy (MSA) — all drugs for Multiple System Atrophy (MSA) →
Progressive Supranuclear Palsy (PSP) — all drugs for Progressive Supranuclear Palsy (PSP) →

Sponsor

GE Healthcare — full company profile →

Who can join

Adults 40 to 80, any sex, with Parkinsonian Syndrome or Parkinson Disease(PD). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sensitivity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images Primary · At Day 1

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 1-Sensitivity

Group	Value	95% CI
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)	0.851	0.750 – 0.923

Reader 2-Sensitivity

Group	Value	95% CI
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)	0.865	0.765 – 0.933

Reader 3-Sensitivity

Group	Value	95% CI
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)	0.919	0.832 – 0.970

Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images Secondary · At Day 1

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™.

Anterior putamen right ratio

Group	Value	95% CI
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)	1.29315	± 0.577528
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)	2.70530	± 0.577359
DaTSCAN™ Ioflupane: Healthy Volunteers (HV)	2.94013	± 0.835608

Anterior putamen left ratio

Group	Value	95% CI
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)	1.30474	± 0.635803
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)	2.67536	± 0.585852
DaTSCAN™ Ioflupane: Healthy Volunteers (HV)	2.92746	± 0.784174

Caudatus asymmetry ratio

Group	Value	95% CI
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)	0.10454	± 0.083195
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)	0.03906	± 0.029737
DaTSCAN™ Ioflupane: Healthy Volunteers (HV)	0.04212	± 0.023939

Caudatus left ratio

Group	Value	95% CI
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)	1.70232	± 0.758242
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)	2.87229	± 0.648102
DaTSCAN™ Ioflupane: Healthy Volunteers (HV)	3.05874	± 0.866446

Caudatus right ratio

Group	Value	95% CI
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)	1.71398	± 0.660892
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)	2.86571	± 0.616034
DaTSCAN™ Ioflupane: Healthy Volunteers (HV)	2.99258	± 0.885231

Putamen to caudatus left ratio

Group	Value	95% CI
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)	0.81527	± 0.113790
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)	0.91598	± 0.071819
DaTSCAN™ Ioflupane: Healthy Volunteers (HV)	0.94217	± 0.075958

Putamen to caudatus right ratio

Group	Value	95% CI
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)	0.80208	± 0.094132
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)	0.92631	± 0.076093
DaTSCAN™ Ioflupane: Healthy Volunteers (HV)	0.95685	± 0.060599

Putamen asymmetry ratio

Group	Value	95% CI
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)	0.08884	± 0.070714
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)	0.03472	± 0.026388
DaTSCAN™ Ioflupane: Healthy Volunteers (HV)	0.03066	± 0.022587

Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious TEAEs Secondary · From start of study drug administration up to Day 4

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 importa

Participants with TEAEs

Group	Value	95% CI
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)	12
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)	13
DaTSCAN™ Ioflupane: Healthy Volunteers (HV)	8

Participants with Serious TEAEs

Group	Value	95% CI
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)	0
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)	0
DaTSCAN™ Ioflupane: Healthy Volunteers (HV)	0

Specificity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images Primary · At Day 1

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 st

Reader 1-Specificity

Group	Value	95% CI
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)	0.933	0.851 – 0.978

Reader 2-Specificity

Group	Value	95% CI
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)	0.960	0.888 – 0.992

Reader 3-Specificity

Group	Value	95% CI
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)	0.813	0.707 – 0.894

Adverse events — posted to ClinicalTrials.gov

Time frame: From start of study drug administration up to Day 4. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)

Serious: 0/75 (0%)

Deaths: 0/75

DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)

Serious: 0/75 (0%)

Deaths: 0/75

DaTSCAN™ Ioflupane: Healthy Volunteers (HV)

Serious: 0/22 (0%)

Deaths: 0/22

Other adverse events (24 terms — click to expand)

Reaction	System	DaTSCAN™ Ioflupane: Partic…	DaTSCAN™ Ioflupane: Partic…	DaTSCAN™ Ioflupane: Health…
Paraesthesia	Nervous system disorders	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Blood glucose increased	Investigations	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—
White blood cells urine positive	Investigations	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—
Dry eye	Eye disorders	—	—	—
Hypoaesthesia oral	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Injection site paraesthesia	General disorders	—	—	—
Conjunctivitis	Infections and infestations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Protein urine present	Investigations	—	—	—
Blood phosphorus decreased	Investigations	—	—	—
Neutrophil count increased	Investigations	—	—	—
Urinary occult blood positive	Investigations	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Haematuria	Renal and urinary disorders	—	—	—
Dermatitis allergic	Skin and subcutaneous tissue disorders	—	—	—
Hypertension	Vascular disorders	—	—	—

Data from ClinicalTrials.gov NCT04193527 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The Potential of Metabolomics to Find Proper Biomarkers for Addressing the Neuroprotective Efficacy of Drugs Aimed at Delaying Parkinson's and Alzheimer's Disease Progression.
Franco R, Garrigós C, Lillo J, Rivas-Santisteban R. · · 2024 · cited 5× · PMID 39120318 · DOI 10.3390/cells13151288

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04193527 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GE Healthcare
Last refreshed: 16 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04193527.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing