Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Minneapolis, Minnesota 55455


Purpose:

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.


Study summary:

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


Criteria:

Inclusion Criteria: - all patients referred Exclusion Criteria: - anyone who wishes to not participate and cannot lay on the table for an additional 30 minutes.


Study is Available At:


Original ID:

201503M65881


NCT ID:

NCT02455219


Secondary ID:


Study Acronym:


Brief Title:

DatScan With Prototype Collimator


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

50 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Minnesota - Clinical and Translational Science Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Actual


Study Dates

Start Date:June 2015
Completion Date:September 2017
Completion Type:Actual
Primary Completion Date:September 2017
Primary Completion Type:Actual
Verification Date:May 2018
Last Changed Date:May 1, 2018
First Received Date:May 15, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:comparing images with prototype collimator to clinical images
Time Frame:baseline
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Prototype UHRSZ (UltraHigh Resolution Smart Zoom)
Description: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.

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Minnesota - Clinical and Translational Science Institute

Samples and Retentions

Study Population: Patients referred to Nuclear Medicine for a clinically indicated DatScan for the diagnosis of Parkinson's disease
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.