Clinical trials: Accuracy of Tissue Diagnosis
Normal Pressure Hydrocephalus
ShuntCheck Accuracy in Detecting Shunt Obstruction Normal Pressure Hydrocephalus (NPH) Patients
The purpose of this study is to examine the role of ShuntCheck and MR Imaging in evaluating the presence or absence of Shunt Obstruction in the patients of Hydrocephalus or Idiopathic Intracranial Hypertension (IIH) undergoing…
- Trial name
- NCT00793416
- Testing
- Shunt flow detection
- Where
- United States
- Sponsor
- NeuroDx Development
Melanoma
MElanoma Research Lymph Node Prediction Implementation National_001
MERLIN_001 is a prospective registry study of a primary melanoma gene-signature to predict sentinel node (SN) status and to determine its prognostic value for more accurate staging of SN-negative melanoma patients.
- Trial name
- MERLIN_001 (NCT04759781)
- Where
- 9 sites in United States
- Volunteers
- 1,820 people
- Sponsor
- SkylineDx
Hydrocephalus
ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients
The purpose of this study is to compare the accuracy of ShuntCheck (SC) and ShuntCheck plus Micro-Pumper (SC+MP) to radionuclide shunt patency testing (SPS) in evaluating shunt function in patients with adult hydrocephalus (AH)…
- Trial name
- SCNPH (NCT01323764)
- Testing
- ShuntCheck test
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- NeuroDx Development
Breast Cancer
Performance of MammoAlert™, Point of Care System, for the Screening of Breast Cancer in Women 18 Years of Age or Older
POC Medical Systems has developed a Point of Care system for the screening of breast cancer in the general population. Via a proprietary algorithm, the MammoAlert™ is expected to determine breast cancer's risk level for a subject…
- Trial name
- NCT03243877
- Testing
- MammoAlert Screening Test
- Where
- 7 sites in India
- Volunteers
- 2,458 people
- Sponsor
- POC Medical Systems, Inc.
Breast Cancer
Case Collection Study to Support Digital Mammography Image Software Change
The primary objective of this study is to compare image processing software to support a new image processing software application for a full-field digital mammography (FFDM) system.
- Trial name
- LIP2SIP (NCT00756496)
- Testing
- Mammography screening and diagnosis
- Volunteers
- 442 people, healthy volunteers welcome
- Sponsor
- Siemens Medical Solutions USA - CSG
Breast Cancer
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study
The purpose of the pivotal reader study is to assess the comparative accuracy of Fujifilm DBT plus S-View versus FFDM in the detection of breast cancer.
- Trial name
- NCT03501693
- Testing
- DBT plus S-View, FFDM Alone
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Glioma, 18F-Fluoroethyl-l-tyrosine
Clinical Benefit of 18F-FET in Glioma.
This Phase II clinical trial, sponsored by Primo Biotechnology Co., Ltd., evaluates the clinical benefit of $^{18}$F-FET PET/CT in diagnosing glioma.
- Trial name
- NCT07698457
- Testing
- 18F-Fluoroethyl-l-tyrosine
- Where
- 4 sites in Taiwan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Primo Biotechnology Co., Ltd
Skin Lesions, Melanocytic Nevi
Evaluating an Artificial Intelligence Tool to Help Primary Care Doctors Diagnose Skin Conditions.
This study aims to determine if an artificial intelligence (AI) medical device can help primary care doctors more accurately identify and manage various skin conditions.
- Conditions
- Skin Lesions, Melanocytic Nevi, Melanoma (Skin Cancer), Basal Cell Carcinoma of Skin
- Trial name
- LegitHealth PH (NCT07428941)
- Testing
- AI-based medical device for aided diagnosis in dermatological conditions
- Where
- Spain
- Volunteers
- 9 people
- Sponsor
- AI Labs Group S.L
Breast Cancer
A Multi-Reader Multi-Case Pivotal Trial
The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm FFDM plus DBT versus FFDM alone in the detection of breast cancer.
- Trial name
- NCT02692209
- Testing
- FFDM Plus DBT, FFDM Alone
- Where
- 5 sites in United States
- Volunteers
- 298 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Breast Cancer, Tumors, Breast
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT)
The aim of this recruitment plan (ADAPT-BX) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results…
- Trial name
- ADAPT (NCT02324205)
- Testing
- DBT and FFDM
- Where
- 3 sites in United States, France
- Volunteers
- 196 people
- Sponsor
- GE Healthcare
Melanoma (Skin), Basal Cell Carcinoma of the Skin
Elucid Labs AIDA™ - Labelled Image Acquisition Protocol
Diagnosis of melanoma involves physical examination of the lesion with many dermatologists adjunctively employing dermoscopes. The rate of misdiagnosis of melanoma remains significant, along with a high rate of referral to…
- Conditions
- Melanoma (Skin), Basal Cell Carcinoma of the Skin, Squamous Cell Carcinoma of the Skin
- Trial name
- NCT03621462
- Testing
- Artificial Intelligence Dermatology Assistant (AIDA™)
- Where
- Canada
- Volunteers
- 4,000 people
- Sponsor
- Elucid Labs Inc.
Lung Cancer, Lung; Nodule
Prospective Evaluation of the Tool-in-lesion Technology of the Galaxy System in Routine Clinical Practice
A prospective observational study evaluating the accuracy of the tool-in-lesion technology of the Galaxy SystemTM in normal clinical practice.
- Trial name
- Match 2 (NCT06685133)
- Testing
- Robotic assisted bronchoscopy
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Noah Medical
Breast Cancer
Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography
Evaluate the diagnostic accuracy of the Planmed Sophie Nuance Full Field Digital Mammography (FFDM) X-ray System compared to screen-film mammography (SFM) in the detection of breast cancer.
- Trial name
- NCT00942396
- Testing
- Full Field Digital Mammogram (Planmed Sophie Nuance)
- Where
- 2 sites in United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Planmed Oy
Hydrocephalus, Normal Pressure Hydrocephalus
A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
The purpose of this study is to determine the agreement rate between the CODMAN Valve Position Verification (VPV) adjustment outcome (reprogramming) and X-ray verification in order to support an alternative to X-ray confirmation…
- Trial name
- NCT00196196
- Testing
- Codman VPV System
- Where
- 8 sites in United States
- Volunteers
- 274 people
- Sponsor
- Codman & Shurtleff
Leiomyoma, Uterine, Leiomyosarcoma Uterus
Accuracy of the Preoperative Molecular Diagnosis of Uterine Tumors by Liquid Biopsy
The development of precise and non-invasive diagnostic methods is a priority in areas such as gynaecology and oncology, and above all in improving the health of those patients with a surgical indication for hysterectomy…
- Trial name
- MYOSARCII (NCT04935333)
- Testing
- Collection of Leiomyoma samples, Collection of Leiomyosarcoma samples, Collection of control samples
- Where
- 21 sites in Spain
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Igenomix
Breast Cancer
MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer
RATIONALE: Imaging procedures, such as MRI, may allow the doctor to better detect the tumor. Highly focused ultrasound energy may be able to kill tumor cells by heating the breast tumor cells without affecting the surrounding…
- Trial name
- NCT00008437
- Testing
- high-intensity focused ultrasound ablation
- Where
- 2 sites in United States, Canada
- Sponsor
- InSightec
Breast Neoplasms, Breast Cancer Detection
Diagnostic Accuracy of Carebot AI MMG in Mammography Screening: Multicenter MRMC Study
This study evaluates the diagnostic performance of Carebot AI MMG, an artificial intelligence (AI)-enabled medical device for evaluating mammograms.
- Conditions
- Breast Neoplasms, Breast Cancer Detection, Breast Cancer - Female, Breast Cancer Screening
- Trial name
- CARE-MMG-MRMC (NCT07298252)
- Testing
- Carebot AI MMG software analysis
- Where
- 4 sites in Czechia, Slovakia
- Volunteers
- 222 people, healthy volunteers welcome
- Sponsor
- Carebot s.r.o.
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
Breast Cancer Diagnosis
PMA Required Pivotal Multi-reader Multi-case Reader Study
A pivotal multi-reader multi-case (MRMC) study to compare the diagnostic performance of 3D Koning Breast Computed Tomography (KBCT) to that of 2D Diagnostic Mammography to support the Pre-market Approval (PMA) of KBCT by the US…
- Trial name
- NCT01952717
- Volunteers
- 236 people
- Sponsor
- Koning Corporation
Breast Cancer, Tumors, Breast
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography
The aim of this recruitment plan (ADAPT-Enrich) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology…
- Trial name
- ADAPT-ENRICH (NCT02540083)
- Testing
- DBT and FFDM
- Where
- 2 sites in United States
- Volunteers
- 94 people
- Sponsor
- GE Healthcare