Development and Clinical Validation of CT-Based Regional Centiloid Method for Amyloid PET

Abstract Background: We developed and validated CT-based regional Centiloid. A CT-based regional Centiloid was developed and validated in the present study. Methods: For development ofMRI-based or CT-based regional CLs,the cohort consist of 63 subjects (20 young controls (YC) and18 old controls (OC), and 25 Alzheimer’s disease dementia (ADD)).We used direct comparison of FMM-FBB CL (dcCL) method using MRI and CT images to define a common target region and six regional VOIs including the frontal, temporal, parietal, posterior cingulate, occipital and striatal regions. Global and regional dcCL scales were compared between MRI-based and CT-based methods. For clinical validation, cohortconsisted of 2,245subjects (627 in CN, 933 in MCI, and 685 in ADD). Results: Both MRI-based and CT-based dcCL scales showed that FMM and FBB were highly correlated with each other, globally and regionally (R2 = 0.96~0.99). Both FMM and FBB showed that CT-based regional dcCL scales were highly correlated with MRI-based regional dcCL scales (R2 = 0.97~0.99). Absolute differences in regional CL scales between CT-based and MRI-based methods seemed to be relatively insignificant (p>0.05). In our clinical validation study, the G(-)R(+) and G(+)Str(+) groups predict worse neuropsychological performance than the G(-)R(-) and the G(+)Str(-) groups (p< 0.05) respectively.Conclusions: Our findings suggested that it is feasible to convert FMM or FBB dcSUVR values into the dcCL scales regionally without additional MRI scans, which might in turn become a more easily accessible method for researchers and be applicable to a variety of different conditions.

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Faculty Opinions recommendation of Automated EEG source imaging: A retrospective, blinded clinical validation study.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.734143825.793565898 ◽

2019 ◽

Author(s):

Christoph Baumgartner

Keyword(s):

Validation Study ◽

Clinical Validation ◽

Source Imaging ◽

Eeg Source Imaging

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406 Clinical Validation of AI Scoring in Adult and Pediatric Clinical PSG Samples Compared to Prospective, Double-Blind Scoring Panel

SLEEP ◽

10.1093/sleep/zsab072.405 ◽

2021 ◽

Vol 44 (Supplement_2) ◽

pp. A161-A161

Author(s):

Chris Fernandez ◽

Sam Rusk ◽

Nick Glattard ◽

Yoav Nygate ◽

Fred Turkington ◽

...

Keyword(s):

Validation Study ◽

Periodic Breathing ◽

Sleep Stages ◽

Clinical Validation ◽

Double Blind ◽

Adult Age ◽

Public Data ◽

Patient Reported ◽

Funding Opportunities ◽

Sensitivity Specificity

Abstract Introduction Despite an appreciable rise in sleep wellness and sleep medicine A.I. research publications, public data corpuses, institutional support, and health A.I. research funding opportunities, the availability of controlled-retrospective, hybrid-retrospective-prospective, and prospective-RCT quality clinical validation study evidence is limited with respect to their potential clinical impact. Furthermore, only a few practical examples of A.I. technologies are validated, in use today clinically, and widely adopted, to assist in sleep diagnoses and treatment. In this study, we contribute to this growing body of clinical A.I. validation evidence and experimental design methodologies with an interoperable A.I. scoring engine in Adult and Pediatric populations. Methods Stratified random sampling with proportionate allocation was applied to a database of N>10,000 retrospective diagnostic clinical polysomnography (PSG), selected by evidence grading standards, with controls applied for OSA severity, diagnoses; sleep, psychiatric, neurologic, neurodevelopmental, cardiac, pulmonary, metabolic disorders, medications; benzodiazepines, antidepressants, stimulants, opiates, sleep aids, demographic groups of interest; sex, adult age, pediatric age, BMI, weight, height, and patient-reported sleepiness, to establish representative N=100 Adult and N=100 Pediatric samples. Double Blinded scoring was prospectively collected for each sample by 3 experienced RPSGT certified sleep technologists randomized from a pool of 9 scorers. Sensitivity (PA), Specificity (NA), Accuracy (OA), Kappa (K), and 95% Bootstrap CI’s are presented for sleep stages, OSA/CSA, hypopnea 3%/4%, arousals, limb movements, Cheyenne-Stokes respiration, periodic breathing, atrial fibrillation, and other events, and normative, mild, moderate, and severe OSA categories for global-AHI and REM-AHI. Results for Sleep Staging and OSA Severity Diagnostic Accuracy are summarized. Results A.I. scoring performance meet but in most cases exceeded initial clinical validation study (N=72 Adults, 2017) PA, NA, OA, K point-estimates and confidence-interval results for the 26 event types and 8 AHI-categories evaluated. The Adult sample showed 87%/94% Sensitivity/Specificity across all stages (Wake/N1/N2/N3/REM) and 94%/96% Sensitivity/Specificity for AHI>=15. The Pediatric sample showed 87%/93% Sensitivity/Specificity staging, 89%/98% Sensitivity/Specificity AHI>=15. Observed Accuracy was >90% for Adults and Pediatrics all 26 events and 7 AHI-categories analyzed, except REM-AHI>=5 (85%/82% Adults/Pediatrics). Conclusion We provide clinical validation evidence that demonstrates interoperable A.I. scoring performance in representative Adult and Pediatric patient clinical PSG samples when compared to prospective, double-blind scoring panel. Support (if any):

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Quantification of Blood Flow in Dialysis Access Using Custom-Acquisition Protocol and Imaging Methods: A Clinical Validation Study

Journal of Vascular and Interventional Radiology ◽

10.1016/j.jvir.2018.10.023 ◽

2019 ◽

Vol 30 (7) ◽

pp. 1062-1068.e2 ◽

Cited By ~ 1

Author(s):

Nischal Koirala ◽

Nikunj Chauhan ◽

Dustin Thompson ◽

Zahra Karimloo ◽

Kevin Wunderle ◽

...

Keyword(s):

Blood Flow ◽

Validation Study ◽

Dialysis Access ◽

Clinical Validation ◽

Acquisition Protocol ◽

Imaging Methods

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A novel detection methodology for HER2 protein quantitation in formalin-fixed, paraffin embedded clinical samples using fluorescent nanoparticles: an analytical and clinical validation study

BMC Cancer ◽

10.1186/s12885-018-5172-1 ◽

2018 ◽

Vol 18 (1) ◽

Cited By ~ 1

Author(s):

David G. Hicks ◽

Brandon Buscaglia ◽

Hideki Goda ◽

Loralee McMahon ◽

Takako Natori ◽

...

Keyword(s):

Validation Study ◽

Clinical Samples ◽

Fluorescent Nanoparticles ◽

Clinical Validation ◽

Her2 Protein ◽

Protein Quantitation ◽

Formalin Fixed Paraffin ◽

Formalin Fixed Paraffin Embedded ◽

Formalin Fixed

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Axial cortical involvement of metastatic lesions to identify impending femoral fractures; a clinical validation study

Radiotherapy and Oncology ◽

10.1016/j.radonc.2019.10.007 ◽

2020 ◽

Vol 144 ◽

pp. 59-64

Author(s):

C.W.P.G. van der Wal ◽

F. Eggermont ◽

M. Fiocco ◽

H.M. Kroon ◽

O. Ayu ◽

...

Keyword(s):

Validation Study ◽

Femoral Fractures ◽

Clinical Validation ◽

Metastatic Lesions ◽

Cortical Involvement

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Measurement of extravascular lung water to diagnose severe reperfusion lung injury following pulmonary endarterectomy: a prospective cohort clinical validation study

Anaesthesia ◽

10.1111/anae.14744 ◽

2019 ◽

Vol 74 (10) ◽

pp. 1282-1289 ◽

Cited By ~ 1

Author(s):

A. G. Butchart ◽

V. Zochios ◽

S. S. Villar ◽

N. L. Jones ◽

S. Curry ◽

...

Keyword(s):

Lung Injury ◽

Validation Study ◽

Extravascular Lung Water ◽

Prospective Cohort ◽

Clinical Validation ◽

Pulmonary Endarterectomy ◽

Lung Water

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Better Luck This Year: OncoCyte’s Clinical Validation Study for Lung Cancer Diagnostic Delayed

Clinical OMICs ◽

10.1089/clinomi.05.01.01 ◽

2018 ◽

Vol 5 (1) ◽

pp. 3, 6

Author(s):

Alex Philippidis

Keyword(s):

Lung Cancer ◽

Validation Study ◽

Clinical Validation ◽

Cancer Diagnostic

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Clinical validation of renin monoclonal antibody-based sandwich assays of renin and prorenin, and use of renin inhibitor to enhance prorenin immunoreactivity

Clinical Chemistry ◽

10.1093/clinchem/42.7.1051 ◽

1996 ◽

Vol 42 (7) ◽

pp. 1051-1063 ◽

Cited By ~ 49

Author(s):

F H Derkx ◽

R J de Bruin ◽

J M van Gool ◽

M J van den Hoek ◽

C C Beerendonk ◽

...

Keyword(s):

Healthy Subjects ◽

Plasma Concentrations ◽

Renin Inhibitor ◽

Clinical Validation ◽

Enzyme Kinetic ◽

Kinetic Assay ◽

Assay Result ◽

High Concentrations ◽

Highly Correlated ◽

Sandwich Assays

Abstract Newly developed IRMAs to measure the plasma concentrations of renin and prorenin were validated for clinical use and compared with a classical enzyme kinetic assay. The IRMAs involve two monoclonal antibodies, one that reacts equally well with renin and prorenin and one that recognizes renin well but prorenin only minimally. Prorenin reactivity with the second antibody was enhanced by adding the renin inhibitor, Remikiren, to plasma. The complex of prorenin with this active-site ligand undergoes a conformational change, whereby prorenin is converted into a form that cannot be differentiated from renin by the IRMA. The linear working range of the assay was 4.0-3000 mU/L. The concentration of prorenin was calculated by subtracting the assay result obtained without Remikiren (i.e., renin) from the result obtained with Remikiren (i.e., renin plus prorenin). No more than 2% of prorenin present in plasma was detected as renin. The interassay CVs for renin quantification were 18%, 13%, and 8% at low, medium, and high concentrations, respectively. The interassay CV for calculated prorenin was 8% at both low and high concentrations. The IRMA results were highly correlated with those of an enzyme kinetic assay in healthy subjects; in patients with such conditions as primary hyperaldosteronism, renovascular hypertension, and low-, medium-, and high-renin essential hypertension; and in women undergoing gonadotropin stimulation.

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