Clinical trials: Reader Study
Breast Neoplasms
Reader Study for Image Quality of Cone Beam Breast CT System
Koning Breast CT (KBCT) was approved by FDA PMA. The X-ray detector originally used in Koning Breast CT was PaxScan 4030CB. Recently, Koning Breast CT uses a modified X-ray detector PaxScan 4030MCT.
- Trial name
- NCT02864667
- Volunteers
- 10 people
- Sponsor
- Koning Corporation
Breast Cancer, Breast Tumor Benign
Evaluation of Carebot AI MMG Medical Device for Breast Lesion Detection and Density Assessment
Comparison of accuracy of clinician and DLAD image evaluation (Carebot AI MMG v2.2) 1. Comparison of the Accuracy of Density Assessment by Clinician and DLAD (DENS) 2.
- Trial name
- EMBLEDDA-MMG (NCT06428799)
- Testing
- Carebot AI MMG
- Where
- 3 sites in Czechia
- Volunteers
- 122 people
- Sponsor
- Carebot s.r.o.
Nevi, Dysplastic
INTER-PATHOLOGIST READER STUDY
This is a post study histology analysis from previously obtained pathology slides.
- Trial name
- NCT06246903
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Orlucent, Inc
Breast Cancer
Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer
This study aims to evaluate Effectiveness of Investigational Device, Lunit INSIGHT MMG, in the assistance of Detection and Diagnosis of Breast Cancer during Screening Mammography Interpretation.
- Trial name
- NCT05615298
- Testing
- Mammography
- Where
- United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Lunit Inc.
Breast Cancer
Pilot 3D Mammography Reader Study to Assess Breast Cancer Detection in 3D Versus 2D Digital Mammography
The purpose of this pilot study is to provide credible performance estimate information in order to properly plan, design, and power a larger clinical study.
- Trial name
- 3DM (NCT01928992)
- Testing
- 3D, 2D
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Prostate Cancer, Metastasis
Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients
This will be a confirmatory, prospective, open-label, single-arm, reader-blinded, multi-centre phase 3 study to assess the diagnostic accuracy and safety of Ferrotran®-enhanced MRI in comparison to unenhanced MRI in the detection…
- Conditions
- Prostate Cancer, Metastasis, Prostatectomy
- Trial name
- NCT04261777
- Testing
- Ferrotran® (Ferumoxtran-10)
- Where
- 15 sites in Belgium, Germany and 2 more
- Volunteers
- 172 people
- Sponsor
- Saving Patients' Lives Medical B.V.
Breast Cancer
Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program
The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation…
- Trial name
- NCT02685566
- Testing
- FFDM Plus DBT, FFDM
- Where
- 5 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Breast Cancer, Breast Neoplasms
Delphinus SoftVue™ ROC Reader Study
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in…
- Trial name
- DMT SV RRS1 (NCT03698942)
- Testing
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Delphinus Medical Technologies, Inc.
Peripheral Vascular Disease
Magnevist® Injection Enhanced MRA at Two Dose Levels Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Infrarenal Aorta and Peripheral Arteries
The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the infrarenal aorta and peripheral arteries.
- Trial name
- NCT00185276
- Testing
- Gadopentetate dimeglumine (Magnevist, BAY86-4882)
- Volunteers
- 365 people
- Sponsor
- Bayer
Breast Cancer Detection, Dense Breast Parenchyma
Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in…
- Conditions
- Breast Cancer Detection, Dense Breast Parenchyma, Benign Breast Findings, Normal Breast Screening
- Trial name
- DMT SV RRS3 (NCT04260620)
- Testing
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Delphinus Medical Technologies, Inc.
Breast Cancer
Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone
The purpose of this pilot is to provide credible performance estimate information in order to conduct subsequent reader studies.
- Trial name
- NCT02511730
- Testing
- FFDM Plus DBT, FFDM
- Where
- 4 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Breast Cancer
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer
The purpose of this pilot is to provide credible performance estimate information in order to conduct a subsequent pivotal reader study.
- Trial name
- NCT03491917
- Testing
- DBT plus S-View, FFDM alone
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Reader Study
HS2 US Liver Reader Study
The purpose of this study is to to assess the ability of 5 Gastro-Intestinal (GI) surgeons, within liver surgery, the readers, to identify pre-defined anatomical landmarks in liver images processed by HS2, and assessment of…
- Trial name
- NCT05783284
- Testing
- Holocare Studio 2 (HS2)
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- HoloCare AS
Chronic Constipation
Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity
To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor activity in subjects that are chronically constipated.
- Trial name
- NCT01707667
- Testing
- prucalopride, PEG 3350
- Where
- 3 sites in United States, Belgium and 1 more
- Volunteers
- 13 people
- Sponsor
- Shire
Lung Cancer
Clinical Evaluation of the V5-LU01 AI Software in Thoracic CT for V5med Inc.
STUDY DESIGN: This is a two-arm retrospective, multi-reader, multi-case, (MRMC) randomized reader study. OBJECTIVE: Primary: The primary objective of this clinical study is to prove that radiologist's performance aided with V5med…
- Trial name
- NCT06514248
- Testing
- V5med Lung AI
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- V5med Inc.
Congenital Heart Disease
Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study
Clinical performance of the device will be evaluated in a fully-crossed, multiple-reader multiple-case (MRMC) study. This study will be used to determine the impact of the device on reader performance in identifying suspicious…
- Trial name
- NCT06392555
- Testing
- Device-Aided performances, Device-Unaided performances
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- BrightHeart
Cognitive Impairment
A Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training Programme in Europe
This is a study to determine the effectiveness of the VIZAMYL™ reader training programme in clinical practice in Europe
- Trial name
- NCT04773015
- Where
- 10 sites in Austria, Finland and 3 more
- Volunteers
- 227 people
- Sponsor
- GE Healthcare
Breast Cancer
Effectiveness of CadAI-B for Breast
The purpose of this study is to evaluate the effectiveness of lesion detection and diagnosis-aiding software (CadAI-B for Breast) during ultrasound (US) examination
- Trial name
- NCT06352684
- Testing
- CadAI-B for Breast
- Where
- South Korea
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- BeamWorks Inc.
Renal Artery Stenosis
Magnevist® Injection-enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis of the Renal Arteries
The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the renal arteries.
- Trial name
- NCT00310557
- Testing
- Gadopentetate dimeglumine (Magnevist)
- Volunteers
- 116 people
- Sponsor
- Bayer
Dermatitis, Melanoma (Skin Cancer)
Using Artificial Intelligence to Help Doctors Identify Different Skin Conditions and Improve Patient Care
This study aims to determine if an artificial intelligence (AI) medical device can help doctors more accurately identify a wide variety of skin conditions and improve the efficiency of patient consultations.
- Conditions
- Dermatitis, Melanoma (Skin Cancer), Alopecia, Urticaria
- Trial name
- LegitHealthSAN (NCT07428954)
- Testing
- AI-based medical device for aided diagnosis in Dermatology
- Where
- Spain
- Volunteers
- 16 people
- Sponsor
- AI Labs Group S.L