Trial Outcomes & Findings for A Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training Programme in Europe (NCT NCT04773015)
NCT ID: NCT04773015
Last Updated: 2024-10-10
Results Overview
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.
COMPLETED
227 participants
Up to 1093 days
2024-10-10
Participant Flow
Participant milestones
| Measure |
VIZAMYL™
Participants who received a single VIZAMYL™ injection intravenously prior to positron emission tomography (PET) brain imaging, as per the clinical practice.
|
All Clinical Readers
Clinical readers had been trained to interpret VIZAMYL™ images using an in-person training programme. They read the Vizamyl images.
|
|---|---|---|
|
Overall Study
STARTED
|
209
|
18
|
|
Overall Study
COMPLETED
|
209
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training Programme in Europe
Baseline characteristics by cohort
| Measure |
VIZAMYL™
n=209 Participants
Participants who received a single VIZAMYL™ injection intravenously prior to PET brain imaging, as per the clinical practice.
|
All Clinical Readers
n=18 Participants
Clinical readers had been trained to interpret VIZAMYL™ images using an in-person training programme. They read the Vizamyl images.
|
Total
n=227 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 8.81 • n=99 Participants
|
51.3 years
STANDARD_DEVIATION 98.4 • n=107 Participants
|
NA years
STANDARD_DEVIATION NA • n=206 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
176 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
191 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Missing
|
30 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 1093 daysPopulation: The efficacy population included participants who had an interpretable image that had an available standard of truth (SOT) classification (expert majority image interpretation).
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.
Outcome measures
| Measure |
VIZAMYL™
n=209 PET image interpretations
Participants who received a single VIZAMYL™ injection intravenously prior to PET brain imaging, as per the clinical practice.
|
|---|---|
|
Accuracy of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
|
83.25 Percentage of image interpretations
Interval 77.49 to 88.05
|
PRIMARY outcome
Timeframe: Up to 1093 daysPopulation: The efficacy population included participants who had an interpretable image that had an available SOT classification (expert majority image interpretation).
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.
Outcome measures
| Measure |
VIZAMYL™
n=209 PET image interpretations
Participants who received a single VIZAMYL™ injection intravenously prior to PET brain imaging, as per the clinical practice.
|
|---|---|
|
Sensitivity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
|
92.24 Percentage of image interpretations
Interval 85.78 to 96.39
|
PRIMARY outcome
Timeframe: Up to 1093 daysPopulation: The efficacy population included participants who had an interpretable image that had an available SOT classification (expert majority image interpretation).
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.
Outcome measures
| Measure |
VIZAMYL™
n=209 PET image interpretations
Participants who received a single VIZAMYL™ injection intravenously prior to PET brain imaging, as per the clinical practice.
|
|---|---|
|
Specificity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
|
72.04 Percentage of image interpretations
Interval 61.78 to 80.86
|
PRIMARY outcome
Timeframe: Up to 1093 daysPopulation: The efficacy population included participants who had an interpretable image that had an available SOT classification (expert majority image interpretation).
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.
Outcome measures
| Measure |
VIZAMYL™
n=209 PET image interpretations
Participants who received a single VIZAMYL™ injection intravenously prior to PET brain imaging, as per the clinical practice.
|
|---|---|
|
Positive Predictive Value (PPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
|
80.45 Percentage of image interpretations
Interval 72.68 to 86.81
|
PRIMARY outcome
Timeframe: Up to 1093 daysPopulation: The efficacy population included participants who had an interpretable image that had an available SOT classification (expert majority image interpretation).
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.
Outcome measures
| Measure |
VIZAMYL™
n=209 PET image interpretations
Participants who received a single VIZAMYL™ injection intravenously prior to PET brain imaging, as per the clinical practice.
|
|---|---|
|
Negative Predictive Value (NPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
|
88.16 Percentage of image interpretations
Interval 78.71 to 94.44
|
SECONDARY outcome
Timeframe: Up to 1093 daysPopulation: The efficacy clinical reader population consisted of 18 clinical readers who had interpreted the images included from his/her institution and had at least one of their image interpretations classified as TP, TN, FP, or FN through comparison with the SOT (the expert blinded reader majority interpretation).
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.
Outcome measures
| Measure |
VIZAMYL™
n=18 Participants
Participants who received a single VIZAMYL™ injection intravenously prior to PET brain imaging, as per the clinical practice.
|
|---|---|
|
Correlation Coefficient Between Clinical Reader Age and Accuracy
|
-0.2415 Correlation coefficient
|
SECONDARY outcome
Timeframe: Up to 1093 daysPopulation: The efficacy clinical reader population consisted of 18 clinical readers who had interpreted the images included from his/her institution and had at least one of their image interpretations classified as TP, TN, FP, or FN through comparison with the SOT (the expert blinded reader majority interpretation).
Number of participants with accuracy \< 0.9333 or \>= 0.9333 in terms of sex of clinical readers were reported.
Outcome measures
| Measure |
VIZAMYL™
n=18 Participants
Participants who received a single VIZAMYL™ injection intravenously prior to PET brain imaging, as per the clinical practice.
|
|---|---|
|
Number of Participants With Accuracy Less Than (<) 0.9333 or Greater Than Equal to (>=) 0.9333 in Terms of Sex of Clinical Readers
Accuracy < 0.9333: Male
|
6 Participants
|
|
Number of Participants With Accuracy Less Than (<) 0.9333 or Greater Than Equal to (>=) 0.9333 in Terms of Sex of Clinical Readers
Accuracy < 0.9333: Female
|
5 Participants
|
|
Number of Participants With Accuracy Less Than (<) 0.9333 or Greater Than Equal to (>=) 0.9333 in Terms of Sex of Clinical Readers
Accuracy >= 0.9333: Male
|
5 Participants
|
|
Number of Participants With Accuracy Less Than (<) 0.9333 or Greater Than Equal to (>=) 0.9333 in Terms of Sex of Clinical Readers
Accuracy >= 0.9333: Female
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 1093 daysPopulation: The efficacy clinical reader population consisted of 18 clinical readers who had interpreted the images included from his/her institution and had at least one of their image interpretations classified as TP, TN, FP, or FN through comparison with the SOT (the expert blinded reader majority interpretation). Here, 'number analyzed' included all clinical readers who were trained or not trained type with clinical reader accuracy.
Number of participants with association of electronic training (with or without In-person training) with clinical reader accuracy were reported.
Outcome measures
| Measure |
VIZAMYL™
n=18 Participants
Participants who received a single VIZAMYL™ injection intravenously prior to PET brain imaging, as per the clinical practice.
|
|---|---|
|
Number of Participants With Association of Electronic Training (With or Without In-Person Training) With Clinical Reader Accuracy
Accuracy >= 0.9333: Trained electronically
|
2 Participants
|
|
Number of Participants With Association of Electronic Training (With or Without In-Person Training) With Clinical Reader Accuracy
Accuracy >= 0.9333: Not Trained electronically
|
5 Participants
|
|
Number of Participants With Association of Electronic Training (With or Without In-Person Training) With Clinical Reader Accuracy
Accuracy < 0.9333: Trained electronically
|
8 Participants
|
|
Number of Participants With Association of Electronic Training (With or Without In-Person Training) With Clinical Reader Accuracy
Accuracy < 0.9333: Not Trained electronically
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 1093 daysPopulation: The efficacy clinical reader population consisted of 18 clinical readers who had interpreted the images included from his/her institution and had at least one of their image interpretations classified as TP, TN, FP, or FN through comparison with the SOT (the expert blinded reader majority interpretation). Here, 'Number analyzed' included all clinical readers who were trained or not trained type with clinical reader accuracy.
Number of participants with association of In-person training (with or without electronic training) with clinical reader accuracy were reported.
Outcome measures
| Measure |
VIZAMYL™
n=18 Participants
Participants who received a single VIZAMYL™ injection intravenously prior to PET brain imaging, as per the clinical practice.
|
|---|---|
|
Number of Participants With Association of In-Person Training (With or Without Electronic Training) With Clinical Reader Accuracy
Accuracy < 0.9333: Not trained in person
|
6 Participants
|
|
Number of Participants With Association of In-Person Training (With or Without Electronic Training) With Clinical Reader Accuracy
Accuracy < 0.9333: Trained in person
|
5 Participants
|
|
Number of Participants With Association of In-Person Training (With or Without Electronic Training) With Clinical Reader Accuracy
Accuracy >= 0.9333: Trained in person
|
6 Participants
|
|
Number of Participants With Association of In-Person Training (With or Without Electronic Training) With Clinical Reader Accuracy
Accuracy >= 0.9333: Not trained in person
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 1093 daysPopulation: Efficacy clinical reader population. Here 'Overall number of participants analyzed' included all clinical readers who were trained type with clinical reader accuracy and 'number analyzed' signifies who were trained with clinical reader accuracy at specific category.
Number of participants with association of training type with clinical reader accuracy (excluding readers who took both types) were reported.
Outcome measures
| Measure |
VIZAMYL™
n=15 Participants
Participants who received a single VIZAMYL™ injection intravenously prior to PET brain imaging, as per the clinical practice.
|
|---|---|
|
Number of Participants With Association of Training Type With Clinical Reader Accuracy (Excluding Readers Who Took Both Types)
Accuracy >= 0.9333: Trained electronically only
|
1 Participants
|
|
Number of Participants With Association of Training Type With Clinical Reader Accuracy (Excluding Readers Who Took Both Types)
Accuracy >= 0.9333: Trained in person only
|
5 Participants
|
|
Number of Participants With Association of Training Type With Clinical Reader Accuracy (Excluding Readers Who Took Both Types)
Accuracy < 0.9333: Trained in person only
|
3 Participants
|
|
Number of Participants With Association of Training Type With Clinical Reader Accuracy (Excluding Readers Who Took Both Types)
Accuracy < 0.9333: Trained electronically only
|
6 Participants
|
SECONDARY outcome
Timeframe: Retrospective data covering up to 8.1 yearsPopulation: The efficacy clinical reader population consisted of 18 clinical readers who had interpreted the images included from his/her institution and had at least one of their image interpretations classified as TP, TN, FP, or FN through comparison with the SOT (the expert blinded reader majority interpretation).
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.
Outcome measures
| Measure |
VIZAMYL™
n=18 Participants
Participants who received a single VIZAMYL™ injection intravenously prior to PET brain imaging, as per the clinical practice.
|
|---|---|
|
Time From Last Training
|
3.45 Years
Interval 1.4 to 8.1
|
Adverse Events
VIZAMYL™
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
- Publication restrictions are in place