An observational study in Cognitive Impairment, sponsored by GE Healthcare. Completed at 10 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-10.
Sponsored by GE Healthcare · Observational
This is a study to determine the effectiveness of the VIZAMYL™ reader training programme in clinical practice in Europe
This study is a combination of Prospective and Retrospective models.
3,930 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.
This study's enrollment of 227 is above the median of 150 across 989 observational studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →GE Healthcare is the lead sponsor of 175 studies on the registry; 20 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
tertiary referral
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Exclusion Criteria:
Accuracy of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
Accuracy was estimated as 100 percent (%) \*(number of true positives \[TP\] + number of true negatives \[TN\]) / (number of TP + number of TN + number of false positives \[FP\] + number of false negatives \[FN\]). The data presented are the point estimates representing percentage of accuracy, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Time frame: Up to 1093 days
Sensitivity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
Sensitivity was defined as 100%\*number of TP / (number of TP + number of FN). The data presented are the point estimates representing percentage sensitivity, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Time frame: Up to 1093 days
Specificity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
Specificity was defined as 100%\*number of TN / (number of TN + number of FP). The data presented are the point estimates representing the percentage specificity, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Time frame: Up to 1093 days
Positive Predictive Value (PPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
The PPV was defined as 100%\*number of TP / (number of TP + number of FP). The data presented are the point estimates representing percentage PPV, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Time frame: Up to 1093 days
Negative Predictive Value (NPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
The NPV was defined as 100%\*number of TN/ (number of TN + number of FN). The data presented are the point estimates representing percentage NPV, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Time frame: Up to 1093 days
Correlation Coefficient Between Clinical Reader Age and Accuracy
Correlation coefficient was used to assess the correlation between clinical reader age and accuracy. A scatterplot of clinical reader accuracy vs. reader age was plotted to check correlation (coefficient) between accuracy and age.
Time frame: Up to 1093 days
Number of Participants With Accuracy Less Than (<) 0.9333 or Greater Than Equal to (>=) 0.9333 in Terms of Sex of Clinical Readers
Number of participants with accuracy \< 0.9333 or \>= 0.9333 in terms of sex of clinical readers were reported.
Time frame: Up to 1093 days
Number of Participants With Association of Electronic Training (With or Without In-Person Training) With Clinical Reader Accuracy
Number of participants with association of electronic training (with or without In-person training) with clinical reader accuracy were reported.
Time frame: Up to 1093 days
Number of Participants With Association of In-Person Training (With or Without Electronic Training) With Clinical Reader Accuracy
Number of participants with association of In-person training (with or without electronic training) with clinical reader accuracy were reported.
Time frame: Up to 1093 days
Number of Participants With Association of Training Type With Clinical Reader Accuracy (Excluding Readers Who Took Both Types)
Number of participants with association of training type with clinical reader accuracy (excluding readers who took both types) were reported.
Time frame: Up to 1093 days
Time From Last Training
Time from last training was reported. Number of readers remaining at timepoint was number of readers with accuracy greater than or equal to 0.9333. All readers met this criterion at time 0 hence, data for all clinical reader is reported. All 18 readers were trained in interpretation of Vizamyl images \& as part of their training, had their interpretation accuracy tested using 15 test images. To pass test, a reader had to interpret atleast 14 of 15 images correctly. 14 represents 0.9333 of 15, so each reader had to have an accuracy of atleast 0.9333 in order to pass test. Date on which a reader took his/her test is considered to be Time 0. Each reader's accuracy at a later time was assessed in study.
Time frame: Retrospective data covering up to 8.1 years
| Milestone | VIZAMYL™ | All Clinical Readers |
|---|---|---|
| Started | 209 | 18 |
| Completed | 209 | 18 |
| Not completed | 0 | 0 |
Accuracy was estimated as 100 percent (%) \*(number of true positives \[TP\] + number of true negatives \[TN\]) / (number of TP + number of TN + number of false positives \[FP\] + number of false negatives \[FN\]). The data presented are the point estimates representing percentage of accuracy, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
| Percentage of image interpretations | VIZAMYL™ |
|---|---|
| Accuracy of VIZAMYL™ PET Image Interpretations Made by Clinical Readers | 83.25 (77.49 to 88.05) |
Sensitivity was defined as 100%\*number of TP / (number of TP + number of FN). The data presented are the point estimates representing percentage sensitivity, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
| Percentage of image interpretations | VIZAMYL™ |
|---|---|
| Sensitivity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers | 92.24 (85.78 to 96.39) |
Specificity was defined as 100%\*number of TN / (number of TN + number of FP). The data presented are the point estimates representing the percentage specificity, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
| Percentage of image interpretations | VIZAMYL™ |
|---|---|
| Specificity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers | 72.04 (61.78 to 80.86) |
The PPV was defined as 100%\*number of TP / (number of TP + number of FP). The data presented are the point estimates representing percentage PPV, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
| Percentage of image interpretations | VIZAMYL™ |
|---|---|
| Positive Predictive Value (PPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers | 80.45 (72.68 to 86.81) |
The NPV was defined as 100%\*number of TN/ (number of TN + number of FN). The data presented are the point estimates representing percentage NPV, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
| Percentage of image interpretations | VIZAMYL™ |
|---|---|
| Negative Predictive Value (NPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers | 88.16 (78.71 to 94.44) |
Correlation coefficient was used to assess the correlation between clinical reader age and accuracy. A scatterplot of clinical reader accuracy vs. reader age was plotted to check correlation (coefficient) between accuracy and age.
| Correlation coefficient | VIZAMYL™- Clinical Readers |
|---|---|
| Correlation Coefficient Between Clinical Reader Age and Accuracy | -0.2415 |
Number of participants with accuracy \< 0.9333 or \>= 0.9333 in terms of sex of clinical readers were reported.
| Participants | VIZAMYL™- Clinical Readers |
|---|---|
| Accuracy < 0.9333: Male | 6 |
| Accuracy < 0.9333: Female | 5 |
| Accuracy >= 0.9333: Male | 5 |
| Accuracy >= 0.9333: Female | 2 |
Number of participants with association of electronic training (with or without In-person training) with clinical reader accuracy were reported.
| Participants | VIZAMYL™- Clinical Readers |
|---|---|
| Accuracy >= 0.9333: Trained electronically | 2 |
| Accuracy >= 0.9333: Not Trained electronically | 5 |
| Accuracy < 0.9333: Trained electronically | 8 |
| Accuracy < 0.9333: Not Trained electronically | 3 |
Number of participants with association of In-person training (with or without electronic training) with clinical reader accuracy were reported.
| Participants | VIZAMYL™- Clinical Readers |
|---|---|
| Accuracy >= 0.9333: Trained in person | 6 |
| Accuracy >= 0.9333: Not trained in person | 1 |
| Accuracy < 0.9333: Trained in person | 5 |
| Accuracy < 0.9333: Not trained in person | 6 |
Number of participants with association of training type with clinical reader accuracy (excluding readers who took both types) were reported.
| Participants | VIZAMYL™- Clinical Readers |
|---|---|
| Accuracy >= 0.9333: Trained electronically only | 1 |
| Accuracy >= 0.9333: Trained in person only | 5 |
| Accuracy < 0.9333: Trained electronically only | 6 |
| Accuracy < 0.9333: Trained in person only | 3 |
Time from last training was reported. Number of readers remaining at timepoint was number of readers with accuracy greater than or equal to 0.9333. All readers met this criterion at time 0 hence, data for all clinical reader is reported. All 18 readers were trained in interpretation of Vizamyl images \& as part of their training, had their interpretation accuracy tested using 15 test images. To pass test, a reader had to interpret atleast 14 of 15 images correctly. 14 represents 0.9333 of 15, so each reader had to have an accuracy of atleast 0.9333 in order to pass test. Date on which a reader took his/her test is considered to be Time 0. Each reader's accuracy at a later time was assessed in study.
| Years | VIZAMYL™- Clinical Readers |
|---|---|
| Time From Last Training | 3.45 (1.4 to 8.1) |
Collected over Up to 1093 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VIZAMYL™ | 0/209 (0%) | 0/209 (0%) | 0/209 (0%) |
Analysis was performed on all participants that is participants who were enrolled in the study and received a dose of VIZAMYL™ and Clinical readers who read the Vizamyl images.
| Age, Continuous(years) | VIZAMYL™ | All Clinical Readers | Total |
|---|---|---|---|
| Mean | 68.1 ± 8.81 | 51.3 ± 98.4 | NA ± NA |
| Sex: Female, Male(Participants) | VIZAMYL™ | All Clinical Readers | Total |
|---|---|---|---|
| Female | 101 | 7 | 108 |
| Male | 108 | 11 | 119 |
| Race/Ethnicity, Customized(Participants) | VIZAMYL™ | All Clinical Readers | Total |
|---|---|---|---|
| White | 176 | 15 | 191 |
| Other | 1 | 1 | 2 |
| Not Reported | 2 | 0 | 2 |
| Missing | 30 | 2 | 32 |
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