DatScan With Prototype Collimator

NCT ID: NCT02455219

Last Updated: 2018-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* all patients referred

Exclusion Criteria

* anyone who wishes to not participate and cannot lay on the table for an additional 30 minutes.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201503M65881

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PharmacoMRI of Parkinson Disease
NCT01528592 COMPLETED NA
PET Study in Parkinson's Disease Patients
NCT01527695 COMPLETED PHASE2
Udall Project 2 Aim 2A&C
NCT05656586 RECRUITING
Connectomic Guided DBS for Parkinson's Disease
NCT06618157 ENROLLING_BY_INVITATION NA