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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Up to 1093 days |
| Negative Predictive Value (NPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1093 days |
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Inclusion Criteria:
Exclusion Criteria:
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tertiary referral
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| Name | Affiliation | Role |
|---|---|---|
| Paul Sherwin, MD, PhD | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kepler Universittsklinikum Neuromed Campus | Linz | Wagner-Jauregg-Weg | 4020 | Austria | ||
| Landeskrankenhaus Vocklabruck |
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| ID | Title | Description |
|---|---|---|
| FG000 | VIZAMYL™ | Participants who received a single VIZAMYL™ injection intravenously prior to positron emission tomography (PET) brain imaging, as per the clinical practice. |
| FG001 | All Clinical Readers | Clinical readers had been trained to interpret VIZAMYL™ images using an in-person training programme. They read the Vizamyl images. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | VIZAMYL™ | Participants who received a single VIZAMYL™ injection intravenously prior to PET brain imaging, as per the clinical practice. |
| BG001 | All Clinical Readers | Clinical readers had been trained to interpret VIZAMYL™ images using an in-person training programme. They read the Vizamyl images. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The efficacy population included participants who had an interpretable image that had an available standard of truth (SOT) classification (expert majority image interpretation). | Posted | Number | 95% Confidence Interval | Percentage of image interpretations | Up to 1093 days | PET image interpretations | PET image interpretations |
|
Up to 1093 days
Analysis was performed on safety population which included participants who were enrolled in the study and received a dose of VIZAMYL™. Adverse event data was not collected from clinical readers as they have not received VIZAMYL™.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VIZAMYL™ | Participants who received a single VIZAMYL™ injection intravenously prior to PET brain imaging, as per the clinical practice. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Sherwin, MD, PhD | GE Healthcare | 609 510 3686 | PaulSherwin@ge.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 19, 2020 | Dec 5, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 6, 2021 | Dec 5, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
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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.
| 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. |
| 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. | 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. | 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. | 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. | Retrospective data covering up to 8.1 years |
| Vöcklabruck |
| 4840 |
| Austria |
| Helsinki University Central Hospital | Helsinki | 00209 | Finland |
| Ospedal Mons Dimicolli - Barletta | Barletta | 70051 | Italy |
| U.O. Medicina Nucleare- ASSST Spedali Civili P.O. di Brescia | Brescia | 25123 | Italy |
| Azienda Ospedaliero Universitaria Careggi - S.O.D. Patologia Medica | Florence | 50134 | Italy |
| Catharina Ziekenhuis | Eindhoven | 5623 | Netherlands |
| Vall d'Hebron University Hospital | Barcelona | 08035 | Spain |
| Hospital Universitari de Bellvitge | Barcelona | 08907 | Spain |
| Clinica Universidad de Navarra | Pamplona | 31008 | Spain |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Primary | 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. | The efficacy population included participants who had an interpretable image that had an available SOT classification (expert majority image interpretation). | Posted | Number | 95% Confidence Interval | Percentage of image interpretations | Up to 1093 days | PET image interpretations | PET image interpretations |
|
|
|
| Primary | 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. | The efficacy population included participants who had an interpretable image that had an available SOT classification (expert majority image interpretation). | Posted | Number | 95% Confidence Interval | Percentage of image interpretations | Up to 1093 days | PET image interpretations | PET image interpretations |
|
|
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| Primary | 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. | The efficacy population included participants who had an interpretable image that had an available SOT classification (expert majority image interpretation). | Posted | Number | 95% Confidence Interval | Percentage of image interpretations | Up to 1093 days | PET image interpretations | PET image interpretations |
|
|
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| Primary | 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. | The efficacy population included participants who had an interpretable image that had an available SOT classification (expert majority image interpretation). | Posted | Number | 95% Confidence Interval | Percentage of image interpretations | Up to 1093 days | PET image interpretations | PET image interpretations |
|
|
|
| Secondary | 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. | 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). | Posted | Number | Correlation coefficient | Up to 1093 days |
|
|
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| Secondary | 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. | 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). | Posted | Count of Participants | Participants | No | Up to 1093 days |
|
|
|
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| Secondary | 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. | 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. | Posted | Count of Participants | Participants | No | Up to 1093 days |
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|
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| Secondary | 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. | 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. | Posted | Count of Participants | Participants | No | Up to 1093 days |
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| Secondary | 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. | 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. | Posted | Count of Participants | Participants | No | Up to 1093 days |
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| Secondary | 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. | 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). | Posted | Median | Full Range | Years | Retrospective data covering up to 8.1 years |
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| 0 |
| 209 |
| 0 |
| 209 |
| 0 |
| 209 |
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| Accuracy >= 0.9333: Female |
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| Accuracy < 0.9333: Trained electronically |
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| Accuracy < 0.9333: Not Trained electronically |
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| Accuracy < 0.9333: Trained in person |
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| Accuracy < 0.9333: Not trained in person |
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| Accuracy < 0.9333: Trained electronically only |
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| Accuracy < 0.9333: Trained in person only |
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