DatScan With Prototype Collimator

Parkinson Disease Clinical Trial

Official title:

Investigating the Use of Siemens Prototype UHRSZ Collimator for Imaging DatScan SPECT/CT Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455219
• Other study ID #: 201503M65881
• Status: Completed
• Start date: June 2015
• Est. completion date: September 2017

Study information

• Verified date: May 2018
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A collimator is an accessory to a SPECT/CT scanner. It can be compared to a camera lens or filter that enhances or improves photos. The prototype collimators are able to magnify target organs about four times compared to the current collimators. In this study we are validating a new collimator design, which will allow for quantitative measurement of dopamine receptors within the brain, not previously performed using a single photon gamma camera.

Description:

Previously PET/CT has been used for this measurement but the L-DOPA is not FDA approved and thus of limited availability. DatScan (I123 ioflupane) is an FDA approved and clinically indicated biomarker, which has a high binding affinity for presynaptic dopamine transporters (DAT) in the brains of mammals, in particular the striatal region of the brain. A feature of Parkinson's disease is a marked reduction in dopaminergic neurons in the striatal region. By introducing an agent that binds to the dopamine transporters a quantitative measure and spatial distribution of the transporters can be obtained. The use of SPECT/CT (with the new validated collimators) and the FDA approved DATScan biomarker would allow for readily available diagnosis of Parkinson's disease

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• all patients referred

Exclusion Criteria:

• anyone who wishes to not participate and cannot lay on the table for an additional 30 minutes.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Prototype UHRSZ (UltraHigh Resolution Smart Zoom) Collimator
In DATScan SPECT scans, the UHRSZ collimator will be exchanged for the standard collimator following completion of the clinically ordered scan. A scanning sequence will be repeated with the prototype collimator in place. Images from the two scanning sequences will be compared.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparing images with prototype collimator to clinical images		baseline