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Obtención de una base de datos de estudios de SPECT con DaTSCAN® correspondiente a una población de sujetos normales - Normales05

Obtención de una base de datos de estudios de SPECT con DaTSCAN® correspondiente a una población de sujetos normales - Normales05

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000895-41-ES
Enrollment
Unknown
Registered
2005-07-08
Start date
2008-11-05
Completion date
Unknown
Last updated
2012-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

With this study we would like to obtain a DaTSCAN SPECT database with normal subjects.

Interventions

Trade Name: DaTSCAN Pharmaceutical Form:

Sponsors

Hospital Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Documented inform consent 2. Subjects aged 36 to 85 with a clinical evidence of no parkinsonian signs or symptoms (assess by UPDRS) and no evidence of any movement disorder. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Drugs that it is known that may interact with DaTSCAN. 2. Any medical condition that may interact with DaTSCAN or yodine pharmachocinetic (i.e. renal or liver failure) 3. Subject with hypersensitivity to yodine 4. Ocupational exposure to radiation higher than 15 mSv/year 5. Current Abuse of drugs or alcohol

Design outcomes

Primary

MeasureTime frame
Main Objective: To Obtain the normal distribution of striatal DAT uptake in a normal population.;Secondary Objective: 1.Characterize the different gammacameras that will be use in the study 2. To obtain a DaTSCAN normal database from normal subjects 3. To adequate the database to be use with other gammacameras and quantification programs;Primary end point(s): To obtain the striatal DaTSCAN uptake ratio in healthy subjects, based on DaTSCAN quantification.

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026