Essential TremorNCT01952678

Compare Rates of Agreement Between Clinical Diagnosis and Visual Assessment of DaTscan™ Images in Non-Caucasian and Caucasian Subjects With Parkinson's Disease (PD) or Essential Tremor (ET)

An observational study of Essential Tremor and Parkinson's Disease, run by GE Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this study is to determine if the diagnostic performance of DaTscan™ single photon emission computed tomography (SPECT) imaging is different in non-Caucasian subjects compared with Caucasian subjects with movement disorders. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Essential Tremor, Parkinson's Disease
What is being tested?: DaTscan™ - Non-Caucasian Participants and DaTscan™ - Caucasian Participants
How many people: 204 participants
Where: 1 siteUnited States
Study dates: 30 Jul 2013to May 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Non-Caucasian and Caucasian Subjects With Parkinson's Disease (PD) or Essential Tremor (ET).

Who may be able to join

For Non-Caucasians:
Non-Caucasian male and female adult participants (greater than or equal to 18 years of age) with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.
The participant had existing diagnostic-quality and interpretable DaTscan SPECT images of the brain.
For Caucasians:
Caucasian male and female adult participants (greater than or equal to 18 years of age) with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.
The participant had existing diagnostic-quality and interpretable DaTscan SPECT images of the brain.
The participant was matched by final clinical diagnosis, sex and age (±5 years) with a non-Caucasian participant.

Who cannot join

Known/suspected structural abnormalities of the brain (e.g., hydrocephalus; brain tumor; stroke; etc.) that could grossly distort the DaTscan images.
Participants whose race and ethnic information could not be determined from source document review.

Trial locations and contacts

1 site in 1 country.

United States1 site

GE Healthcare
Marlborough, Massachusetts, 01752

Other trials in United States

About this study

Official title: A Retrospective Clinical Study to Compare the Rates of Agreement Between Clinical Diagnosis and Visual Assessment of DaTscan™ Images in Non-Caucasian and Caucasian Subjects With Parkinson's Disease (PD) or Essential Tremor (ET)

Conditions: Essential Tremor, Parkinson's Disease
Being tested: DaTscan™ - Non-Caucasian Participants, DaTscan™ - Caucasian Participants
Keywords: DaTscan, Parkinson's Disease
Medical subject headings: Essential Tremor, Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DaTscan™ - Non-Caucasian ParticipantsOther
Participants who previously administered DaTscan™ and had undergone SPECT imaging of the brain per local practice at each institution.
DaTscan™ - Caucasian ParticipantsOther
Participants who previously administered DaTscan™ and had undergone SPECT imaging of the brain per local practice at each institution.

Study groups in NCT01952678
Study group	Role	What they receive
DaTscan™ - Non-Caucasian Participants		Non-Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET. Receives: Other: DaTscan™ - Non-Caucasian Participants
DaTscan™- Caucasian Participants		Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET. Receives: Other: DaTscan™ - Caucasian Participants

What is being measured

The primary outcome is the main question the study is designed to answer.

Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the positive percent agreement (PPA, analogous to sensitivity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.
Measured: Day 1
Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the positive percent agreement (PPA, analogous to sensitivity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.
Measured: Day 1
Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the negative percent agreement (NPA, analogous to specificity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.
Measured: Day 1
Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the negative percent agreement (NPA, analogous to specificity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.
Measured: Day 1

Secondary outcomes (2)

Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
Overall percent agreement (OPA) regardless of image interpretation (analogous to accuracy; ratio of number of true results / number of all participants) for each racial group, was tested to determine if it was greater than 80% in both racial groups. The majority assessment was based on ≥2 of the 3 readers in agreement on the assessment.
Measured: Day 1
Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
Overall percent agreement (OPA) regardless of image interpretation (analogous to accuracy; ratio of number of true results / number of all participants) for each racial group, was tested to determine if it was greater than 80% in both racial groups. The majority assessment was based on ≥2 of the 3 readers in agreement on the assessment.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 2013May 2016

First posted30 Sep 2013 (estimated)
Study start30 Jul 2013
Primary completionMay 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Essential TremorStudies of the same condition, open and under way.
More trials run by GE HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01952678
Sponsor's protocol ID: GE-001-011
Status last verified: Oct 2017
First submitted: 19 Sep 2013
Last updated: 2 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Essential Tremor trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Retrospective Clinical Study to Compare the Rates of Agreement Between Clinical Diagnosis and Visual Assessment of DaTscan™ Images in Non-Caucasian and Caucasian Subjects With Parkinson's Disease (PD) or Essential Tremor (ET)
ClinicalTrials.gov ID: NCT01952678
Acronym / sponsor ID: GE-001-011
Conditions: Essential Tremor, Parkinson's Disease
Keywords: DaTscan, Parkinson's Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Collaborators: H2O Clinical LLC, Quintiles, Inc.
Study start: 30 Jul 2013
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 30 Sep 2013 (estimated)
Results: Posted 2 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
DaTscan™ - Non-Caucasian Participants	–	Other: DaTscan™ - Non-Caucasian ParticipantsNon-Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.
DaTscan™- Caucasian Participants	–	Other: DaTscan™ - Caucasian ParticipantsCaucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Non-Caucasian and Caucasian Subjects With Parkinson's Disease (PD) or Essential Tremor (ET).

Key inclusion criteria (7 listed)

Non-Caucasian male and female adult participants (greater than or equal to 18 years of age) with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.
The participant had existing diagnostic-quality and interpretable DaTscan SPECT images of the brain.
Caucasian male and female adult participants (greater than or equal to 18 years of age) with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.
The participant had existing diagnostic-quality and interpretable DaTscan SPECT images of the brain.
The participant was matched by final clinical diagnosis, sex and age (±5 years) with a non-Caucasian participant.

Key exclusion criteria (2 listed)

Known/suspected structural abnormalities of the brain (e.g., hydrocephalus; brain tumor; stroke; etc.) that could grossly distort the DaTscan images.
Participants whose race and ethnic information could not be determined from source document review.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DaTscan™ - Non-Caucasian ParticipantsParticipants who previously administered DaTscan™ and had undergone SPECT imaging of the brain per local practice at each institution.	Other	DaTscan™ - Non-Caucasian Participants
DaTscan™ - Caucasian ParticipantsParticipants who previously administered DaTscan™ and had undergone SPECT imaging of the brain per local practice at each institution.	Other	DaTscan™- Caucasian Participants

Primary outcome

Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
Time frame: Day 1
The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the positive percent agreement (PPA, analogous to sensitivity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.
Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
Time frame: Day 1
The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the positive percent agreement (PPA, analogous to sensitivity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.
Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
Time frame: Day 1
The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the negative percent agreement (NPA, analogous to specificity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.
Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
Time frame: Day 1
The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the negative percent agreement (NPA, analogous to specificity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.

2 secondary outcomes

Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
Time frame: Day 1
Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
Time frame: Day 1

Results and safety

Results posted to the registry on 2 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DaTscan™- Non-Caucasian Participant	102	102
DaTscan™- Caucasian Participants	102	102

Primary outcome: Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population

Time frame: Day 1. Number (95% Confidence Interval). Unit: Positive percent agreement

Measure	DaTscan™ - Non-Caucasian Participants n = 58	DaTscan™ - Caucasian Participants n = 58
Reader A	86.0 (74.2 to 93.7)	84.2 (72.1 to 92.5)
Reader B	78.9 (66.1 to 88.6)	86.0 (74.2 to 93.7)
Reader C	89.5 (78.5 to 96.0)	87.7 (76.3 to 94.9)
Majority	87.7 (76.3 to 94.9)	86.0 (74.2 to 93.7)

DaTscan™ - Non-Caucasian Participants vs DaTscan™ - Caucasian Participants: Mean Difference (Net): 1.8 (95% CI -17.3 to 20.7), p = 1.0000, Fisher Exact
DaTscan™ - Non-Caucasian Participants vs DaTscan™ - Caucasian Participants: Mean Difference (Net): -7.0 (95% CI -25.8 to 12.1), p = 0.4608, Fisher Exact
DaTscan™ - Non-Caucasian Participants vs DaTscan™ - Caucasian Participants: Mean Difference (Net): 1.8 (95% CI -17.3 to 20.7), p = 1.0000, Fisher Exact

Population analysed: ITD population that included all participants who underwent SPECT imaging after receiving DaTscan™ and enrolled in the study. Here, number of participants analyzed = participants with available data for this outcome measure.

Primary outcome: Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population

Time frame: Day 1. Number (95% Confidence Interval). Unit: Positive percent agreement

Measure	DaTscan™ - Non-Caucasian Participants n = 56	DaTscan™ - Caucasian Participants n = 56
Reader A	85.7 (73.8 to 93.6)	83.9 (71.7 to 92.4)
Reader B	78.6 (65.6 to 88.4)	85.7 (73.8 to 93.6)
Reader C	89.3 (78.1 to 96.0)	87.5 (75.9 to 94.8)
Majority	87.5 (75.9 to 94.8)	85.7 (73.8 to 93.6)

DaTscan™ - Non-Caucasian Participants vs DaTscan™ - Caucasian Participants: Mean Difference (Net): 1.8 (95% CI -17.5 to 20.9), p = 1.0000, Fisher Exact
DaTscan™ - Non-Caucasian Participants vs DaTscan™ - Caucasian Participants: Mean Difference (Net): -7.1 (95% CI -26.1 to 12.2), p = 0.4599, Fisher Exact
DaTscan™ - Non-Caucasian Participants vs DaTscan™ - Caucasian Participants: Mean Difference (Net): 1.8 (95% CI -17.5 to 20.9), p = 1.0000, Fisher Exact

Population analysed: PP population consisted of all participants who met inclusion/exclusion criteria, had DaTscan™ image sets that were considered evaluable by ≥2 of the 3 blinded readers, and had no major protocol violations from any of the matched pair participants. Here, number of participants analyzed = participants with available data for this outcome measure.

Primary outcome: Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population

Time frame: Day 1. Number (95% Confidence Interval). Unit: Negative percent agreement

Measure	DaTscan™- Non-Caucasian Participants n = 44	DaTscan™- Caucasian Participants n = 43
Reader A	93.0 (80.9 to 98.5)	93.0 (80.9 to 98.5)
Reader B	84.1 (69.9 to 93.4)	83.7 (69.3 to 93.2)
Reader C	86.4 (72.6 to 94.8)	88.4 (74.9 to 96.1)
Majority	88.6 (75.4 to 96.2)	88.4 (74.9 to 96.1)

DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants: Mean Difference (Net): 0.0 (95% CI -22.0 to 22.0), p = 1.0000, Fisher Exact
DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants: Mean Difference (Net): 0.4 (95% CI -20.8 to 20.8), p = 1.0000, Fisher Exact
DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants: Mean Difference (Net): -2.0 (95% CI -23.0 to 18.5), p = 1.0000, Fisher Exact

Primary outcome: Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population

Time frame: Day 1. Number (95% Confidence Interval). Unit: Negative percent agreement

Measure	DaTscan™ - Non-Caucasian Participants n = 41	DaTscan™ - Caucasian Participants n = 40
Reader A	92.5 (79.6 to 98.4)	92.5 (79.6 to 98.4)
Reader B	90.2 (76.9 to 97.3)	85.0 (70.2 to 94.3)
Reader C	90.2 (76.9 to 97.3)	90.0 (76.3 to 97.2)
Majority	92.7 (80.1 to 98.5)	90.0 (76.3 to 97.2)

DaTscan™ - Non-Caucasian Participants vs DaTscan™ - Caucasian Participants: Mean Difference (Net): 0.0 (95% CI -22.8 to 22.8), p = 1.0000, Fisher Exact
DaTscan™ - Non-Caucasian Participants vs DaTscan™ - Caucasian Participants: Mean Difference (Net): 5.2 (95% CI -16.7 to 26.2), p = 0.5187, Fisher Exact
DaTscan™ - Non-Caucasian Participants vs DaTscan™ - Caucasian Participants: Mean Difference (Net): 0.2 (95% CI -21.5 to 21.5), p = 1.0000, Fisher Exact

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DaTscan™- Non-Caucasian Participants	0 of 0	0 of 0	Not reported
DaTscan™ - Caucasian Participants	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jose M Zubeldia, M.D. study chair

GE Healthcare

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Essential Tremor and Parkinson's Disease, run by GE Healthcare at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01952678.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.