N/A
Completed N=227
A Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training Programme in Europe
Source: ClinicalTrials.gov NCT04773015 ↗Enrolled (actual)
227
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Accuracy of VIZAMYL™ PET Image Interpretations Made by Clinical Readers — 83.25 Percentage of image interpretations
Summary
This is a study to determine the effectiveness of the VIZAMYL™ reader training programme in clinical practice in Europe
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of VIZAMYL™ PET Image Interpretations Made by Clinical Readers |
83.25 | — |
| PRIMARY Sensitivity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers |
92.24 | — |
| PRIMARY Specificity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers |
72.04 | — |
| PRIMARY Positive Predictive Value (PPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers |
80.45 | — |
| PRIMARY Negative Predictive Value (NPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers |
88.16 | — |
| SECONDARY Correlation Coefficient Between Clinical Reader Age and Accuracy |
-0.2415 | — |
| SECONDARY Number of Participants With Accuracy Less Than (<) 0.9333 or Greater Than Equal to (>=) 0.9333 in Terms of Sex of Clinical Readers |
6; 5; 5; 2 | 0.6371 |
| SECONDARY Number of Participants With Association of Electronic Training (With or Without In-Person Training) With Clinical Reader Accuracy |
2; 5; 8; 3 | 0.1448 |
| SECONDARY Number of Participants With Association of In-Person Training (With or Without Electronic Training) With Clinical Reader Accuracy |
6; 1; 5; 6 | 0.1507 |
| SECONDARY Number of Participants With Association of Training Type With Clinical Reader Accuracy (Excluding Readers Who Took Both Types) |
1; 5; 6; 3 | 0.1189 |
| SECONDARY Time From Last Training |
3.45 | — |
Eligibility Criteria
Inclusion Criteria
- The subject is an adult (aged 18 years or older) of any race or gender and has been referred for a VIZAMYL™ PET brain scan as part of the assessment of his/her cognitive impairment.
- The VIZAMYL™ scan was ordered as part of the clinical care of the subject and is not exclusively for a clinical trial.
- If informed consent is required by the local IEC, the subject, or his/her legally authorised representative, is willing and able to sign consent for use of their de-identified VIZAMYL™ PET images and associated anatomic images (brain CT and/or MRI) used in the interpretation of the VIZAMYL™ images as well as de-identified demographic information.
Exclusion Criteria
- If informed consent is required by the local IEC, the subject (or representative) is not willing to consent to their de-identified images and other data being used in this study.
Data sourced from ClinicalTrials.gov (NCT04773015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.