Trial Outcomes & Findings for 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) (NCT NCT01952678)
NCT ID: NCT01952678
Last Updated: 2018-08-02
Results Overview
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.
COMPLETED
204 participants
Day 1
2018-08-02
Participant Flow
In the present study GE-001-011 (NCT01952678), participants who previously administered DaTscan™ and had undergone single photon emission computed tomography (SPECT) imaging of the brain per local practice at each institution, were enrolled.
A total of 102 non-Caucasian and 102 Caucasian participants were enrolled in the study.
Participant milestones
| Measure |
DaTscan™- Non-Caucasian Participant
Non-Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected Parkinson's disease (PD) or Essential tremor (ET) who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
102
|
|
Overall Study
COMPLETED
|
102
|
102
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
DaTscan™- Non-Caucasian Participants
n=102 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.
|
DaTscan™- Caucasian Participants
n=102 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.
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 11.09 • n=99 Participants
|
66.4 years
STANDARD_DEVIATION 10.67 • n=107 Participants
|
66.4 years
STANDARD_DEVIATION 10.86 • n=206 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
94 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
187 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
28 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
66 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
DaTscan™ - Non-Caucasian Participants
n=58 Participants
Non-Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging and had a final clinical diagnosis of PD.
|
DaTscan™ - Caucasian Participants
n=58 Participants
Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging and had a final clinical diagnosis of PD.
|
|---|---|---|
|
Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
Reader C
|
89.5 Positive percent agreement
Interval 78.5 to 96.0
|
87.7 Positive percent agreement
Interval 76.3 to 94.9
|
|
Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
Majority
|
87.7 Positive percent agreement
Interval 76.3 to 94.9
|
86.0 Positive percent agreement
Interval 74.2 to 93.7
|
|
Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
Reader A
|
86.0 Positive percent agreement
Interval 74.2 to 93.7
|
84.2 Positive percent agreement
Interval 72.1 to 92.5
|
|
Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
Reader B
|
78.9 Positive percent agreement
Interval 66.1 to 88.6
|
86.0 Positive percent agreement
Interval 74.2 to 93.7
|
PRIMARY outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
DaTscan™ - Non-Caucasian Participants
n=56 Participants
Non-Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging and had a final clinical diagnosis of PD.
|
DaTscan™ - Caucasian Participants
n=56 Participants
Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging and had a final clinical diagnosis of PD.
|
|---|---|---|
|
Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
Majority
|
87.5 Positive percent agreement
Interval 75.9 to 94.8
|
85.7 Positive percent agreement
Interval 73.8 to 93.6
|
|
Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
Reader A
|
85.7 Positive percent agreement
Interval 73.8 to 93.6
|
83.9 Positive percent agreement
Interval 71.7 to 92.4
|
|
Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
Reader B
|
78.6 Positive percent agreement
Interval 65.6 to 88.4
|
85.7 Positive percent agreement
Interval 73.8 to 93.6
|
|
Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
Reader C
|
89.3 Positive percent agreement
Interval 78.1 to 96.0
|
87.5 Positive percent agreement
Interval 75.9 to 94.8
|
PRIMARY outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
DaTscan™ - Non-Caucasian Participants
n=44 Participants
Non-Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging and had a final clinical diagnosis of PD.
|
DaTscan™ - Caucasian Participants
n=43 Participants
Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging and had a final clinical diagnosis of PD.
|
|---|---|---|
|
Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
Reader A
|
93.0 Negative percent agreement
Interval 80.9 to 98.5
|
93.0 Negative percent agreement
Interval 80.9 to 98.5
|
|
Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
Reader B
|
84.1 Negative percent agreement
Interval 69.9 to 93.4
|
83.7 Negative percent agreement
Interval 69.3 to 93.2
|
|
Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
Reader C
|
86.4 Negative percent agreement
Interval 72.6 to 94.8
|
88.4 Negative percent agreement
Interval 74.9 to 96.1
|
|
Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
Majority
|
88.6 Negative percent agreement
Interval 75.4 to 96.2
|
88.4 Negative percent agreement
Interval 74.9 to 96.1
|
PRIMARY outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
DaTscan™ - Non-Caucasian Participants
n=41 Participants
Non-Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging and had a final clinical diagnosis of PD.
|
DaTscan™ - Caucasian Participants
n=40 Participants
Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging and had a final clinical diagnosis of PD.
|
|---|---|---|
|
Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
Reader A
|
92.5 Negative percent agreement
Interval 79.6 to 98.4
|
92.5 Negative percent agreement
Interval 79.6 to 98.4
|
|
Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
Reader B
|
90.2 Negative percent agreement
Interval 76.9 to 97.3
|
85.0 Negative percent agreement
Interval 70.2 to 94.3
|
|
Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
Reader C
|
90.2 Negative percent agreement
Interval 76.9 to 97.3
|
90.0 Negative percent agreement
Interval 76.3 to 97.2
|
|
Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
Majority
|
92.7 Negative percent agreement
Interval 80.1 to 98.5
|
90.0 Negative percent agreement
Interval 76.3 to 97.2
|
SECONDARY outcome
Timeframe: Day 1Population: The intent-to-diagnose (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.
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.
Outcome measures
| Measure |
DaTscan™ - Non-Caucasian Participants
n=101 Participants
Non-Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging and had a final clinical diagnosis of PD.
|
DaTscan™ - Caucasian Participants
n=100 Participants
Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging and had a final clinical diagnosis of PD.
|
|---|---|---|
|
Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
Majority
|
88.1 Overall percent agreement
Interval 80.2 to 93.7
|
87.0 Overall percent agreement
Interval 78.8 to 92.9
|
|
Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
Reader A
|
89.0 Overall percent agreement
Interval 81.2 to 94.4
|
88.0 Overall percent agreement
Interval 80.0 to 93.6
|
|
Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
Reader B
|
81.2 Overall percent agreement
Interval 72.2 to 88.3
|
85.0 Overall percent agreement
Interval 76.5 to 91.4
|
|
Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
Reader C
|
88.1 Overall percent agreement
Interval 80.2 to 93.7
|
88.0 Overall percent agreement
Interval 80.0 to 93.6
|
SECONDARY outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
DaTscan™ - Non-Caucasian Participants
n=97 Participants
Non-Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging and had a final clinical diagnosis of PD.
|
DaTscan™ - Caucasian Participants
n=96 Participants
Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging and had a final clinical diagnosis of PD.
|
|---|---|---|
|
Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
Reader C
|
89.7 Overall percent agreement
Interval 81.9 to 94.9
|
88.5 Overall percent agreement
Interval 80.4 to 94.1
|
|
Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
Reader A
|
88.5 Overall percent agreement
Interval 80.4 to 94.1
|
87.5 Overall percent agreement
Interval 79.2 to 93.4
|
|
Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
Reader B
|
83.5 Overall percent agreement
Interval 74.6 to 90.3
|
85.4 Overall percent agreement
Interval 76.7 to 91.8
|
|
Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
Majority
|
89.7 Overall percent agreement
Interval 81.9 to 94.9
|
87.5 Overall percent agreement
Interval 79.2 to 93.4
|
Adverse Events
DaTscan™- Non-Caucasian Participants
DaTscan™ - Caucasian Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI and/or institution is that the Sponsor can review results communications prior to public release and can restrict communications regarding trial results for a period that is more than 30 days (publications/abstracts) but not to exceed 90 days (patent related issues) from the time submitted to the Sponsor to review. The PI may be asked to remove any Sponsor confidential information and/or delay publication to protect any proprietary information.
- Publication restrictions are in place
Restriction type: OTHER