N/A N=480 Optoacoustic Images Versus Imagio® Ultrasound
Breast Cancer
Primary: Gain in Specificity at Fixed 98% Sensitivity (fSp) — 38.22; 47.20 % benign+TPB masses correctly identified — p=0.0268
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=2,105 The PIONEER-01 Study of the Imagio Breast Imaging System
Breast Cancer
Primary: Specificity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS) — 14.9 % benign+TPB masses correctly Id'd
N/A N=217 IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO)
Breast Cancer
Primary: OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses — 41.1 percentage of masses
N/A N=24 Image Quality Assessment for Screening and Diagnostic Mammography
Breast Health
Primary: Number of Participants With Acceptable Overall Clinical Image Quality — 14; 9 Participants
N/A N=408 Prostate Cancer Screening Trial Using Imaging
Prostate Neoplasm
Primary: The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater — 17.7 Percentage of participants
N/A N=38 Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System
Breast Cancer Stage
Primary: Number of Participants With Imagio Image Sets Collected — 38 Participants
N/A N=189 SJM MRI Diagnostic Imaging Registry (IDE)
Cardiac Arrhythmia
Primary: The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation. — 129 MRI Scans
N/A N=1,232 Acquisition of Breast Mammography Images
Breast Cancer
Primary: Number of Participants for Whom Study Image Data Were Collected — 642; 124; 244 Participants
N/A N=298 Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography
Breast Biopsy
Primary: Impact of US-guided DOT on the Potential Reduction of Benign Biopsies as Measured by Comparing the Reads With a Non- Suspicious Assessment of Conventional Imaging (CI)…
N/A N=29 4DCT Imaging for Improved Diagnosis and Treatment of Wrist Ligament Injuries
Scapholunate Interosseous Ligament Injury
Primary: Equivalency of 4DCT-based Treatment Plan to Arthroscopic-based Treatment Plan. — 5; 14; 11 Participants
Phase 2 N=31 Imaging in MGUS, SMM and MM
Multiple Myeloma · Smoldering Multiple Myeloma · Monoclonal Gammopathy of Undetermined Significance
Primary: Count of Participants With Positive and Negative 18F-FDG PET CT and F18-NaF PET CT Imaging Results in Individuals With MGUS, SMM, and MM. — 0; 1; 5; 10 Participants
N/A N=23 Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis
Breast Cancer
Primary: Beta of CT Coronal View — 1.75 power-law slope(B)
N/A N=28 Next Generation X-ray Imaging System
Stroke, Acute
Primary: Ischemic Stroke Diagnostic Accuracy (CBCT Versus CT) — 90; 90 percentage of gold standard
N/A N=20 Image Quality and Radiation Dose in Angiography
Arteriovenous Malformations · Aneurysm · Stenosis
Primary: Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated. — 9.4; 11.9; 13.1; 14.1 Scores on a scale
Phase 2 N=40 Positron Emission Tomography and Magnetic Resonance Imaging for Prostate Cancer
Prostate Cancer
Primary: Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate — 4.4…
N/A N=49 Clinical Evaluation for General Electric (GE) CT System
CT Scanners X Ray
Primary: Image Quality — 4.53; 4.44; 4.63 units on a scale
N/A N=9 Urology of Virginia Case Series
Prostate Cancer · Cancer of the PROSTATE · Prostatic Neoplasm
Primary: Keyword Description of Each Biopsy Sample — 89 percentage significant cancers detected
N/A N=66 Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis
Solitary Pulmonary Nodules
Primary: Radlex Scale for Diagnostic Quality Ratings - DE Predicate PA Chest — 3.4540 units on a scale
N/A N=2,978 Molecular Breast Imaging and Digital Breast Tomosynthesis in Screening Patients With Dense Breast Tissue
Breast Carcinoma
Primary: Rate of Detection of Invasive Cancers — 9; 14 Participants
N/A N=764 Evaluation of the Efficacy of Digital Breast Tomosynthesis Imaging
Breast Cancer
Primary: Efficacy Based on the Area Under the Receiver Operating Characteristic (ROC) Curve in Breasts Analyzed With DBT as an Adjunct to FFDM vs. FFDM Alone — 0.8527; 0.7516…
N/A N=23 Optical Imaging Measurement of Intravascular Solution Efficacy Trial
Peripheral Artery Disease
Primary: Quality of Images — .702; .872; .10; .743 Clear imaging field (CIF) proportion
N/A N=89 Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation
Breast Cancer
Primary: Sensitivity on the Per Patient Level — 25; 27 participants
N/A N=15 PET-MRI in Diagnosing Patients With Colon or Rectal Cancer
Recurrent Colon Cancer · Recurrent Rectal Cancer · Stage IIA Colon Cancer
Primary: Maximum Standardized Uptake Value (SUVmax) in Physiologic Regions and Fluorodeoxyglucose (FDG) Avid Lesions in Participants Where PET-CT Was Performed Prior to the…
N/A N=120 Urology San Antonio MRI/MicroUS Comparison
Prostate Cancer
Primary: Number of Participants With Clinically Significant Cancer — 38; 31 Participants
Phase 4 N=697 Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease
Ischemic Heart Disease
Primary: Diagnosis of IHD at Invasive Coronary Angiography and FFR Measurement — 140 participants
N/A N=15 Advanced MRI Scan Before and After Radiation Therapy for the Detection of Intracranial Metastasis
Malignant Solid Neoplasm
Primary: Contrast to Noise Ratio — 3.2 Ratio — p=< 0.05
N/A N=30 Wrist Fracture Evaluation With a Desktop Orthopedic Tomosynthesis System
Fracture
Primary: Sensitivity — 96.7 percent of scans with a fracture
N/A N=76 Carestream Digital Radiography Long Length Imaging Software Data Collection Protocol
Spinal Injuries
Primary: Radlex Scale for Diagnostic Capability Ratings - Cedara Accustitch Software (Predicate) — 3.01 units on a scale — p=0.02
N/A N=12 Evaluation of Imaging of Peripheral Arteries by Optical Coherence Tomography and Intravascular Ultrasound Imaging
Peripheral Artery Disease
Primary: Visualization of Vessel Morphology: Layered Structure — 1.61; 1.49 score on a scale
Phase 2 N=60 Low Dose ICG for Biliary Tract and Tumor Imaging
Cholecystitis · Hepatocellular Carcinoma · Liver Metastases
Primary: Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio — 2.7; 0.7 ratio