31 Clinical Trials for Various Conditions
The purpose of this study is to acquire the clinical data required by the United States Food and Drug Administration (USFDA) for 510(k) submission, for approval of a new high resolution imaging system for fluoroscopy/radiography. It is expected that the new KALARE (DREX-KL80)high resolution imaging system will meet the design specifications. A minimum of 30 cases will be submitted for evaluation of claims for intended clinical applications.
The purpose of this investigation, using hardcopy film, is to compare the accuracy of the Philips MammoDiagnost DR (FFDM device) and screen-film (SF) mammography in detection of breast cancer among women undergoing screening or diagnostic mammography. Per the new FDA Guidance document for FFDM, accuracy in comparison to Screen-film is no longer required.
This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for imaging viable neonate and infant populations. This MR system has a smaller size and design features that may make it more feasible to locate the system in close proximity to care areas for neonates (birth - 1 month) and infants (less than 1 month to two years), such as clinical neonatal intensive care units (NICUs) and other infant and neonatal care departments.
To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton devices using two light sources.
The goal of this study is to compare a sample of the cyst taken by a standard method (fine needle aspiration) to the sample taken by a new method using a device called the EchoBrush to see which method is more accurate at diagnosing cancer. We will also look at proteins (also called biomarkers) in the samples to see if they predict whether or not the cyst is cancerous.
Image-guided surgery essentially describes the interactive use of medical images during a surgical procedure and is often referred to as a "global positioning" system (GPS) for surgery.
In recent years, more and more people are having lung CT scans performed to screen for various cancers. Many of them have small abnormalities detected, called "nodules", which - for a variety of reasons - doctors are unable to biopsy. As a result, many patients have their CT scans repeated on a regular basis to see if their nodules grow. This process can last several years. Many patients experience significant anxiety during this process, when they are aware of a spot in the lung, but are not told any specific cause. Researchers at Memorial Sloan-Kettering have developed a new way to look at lung nodules in three dimensions. The purpose of this project is to see if any change in the nodules can be detected sooner by this method than by traditional CT scans.
This study performs the first clinical evaluation of the Gen 2 Imagio System in a clinical setting to assess image quality with both the IUS ultrasound only probe and the OA/US (duplex probe).
Comparative Evaluation of Gen1B (OA-16-1S) duplex OA/US probe versus Gen1 (OA-16-1) duplex OA/US probe in Healthy Subjects
This study assesses clinical outcomes following the use of the MvIGS spine navigation system for treatment of spinal stenosis and degenerative spondylolisthesis of the lumbar spine in adults. There will be separate study arms for cases utilizing the three-dimensional (3D) MvIGS spine navigation system and cases that utilize conventional two-dimensional (2D) fluoroscopy.
This study is being done to find out if transperineal ultrasound (TPUS) can help define the prostate bed for radiation treatment planning and improve upon current methods of image guidance for the treatment of prostate cancer. For the patient, TPUS involves the placement of an ultrasound probe on the perineum, the skin between the scrotum and anus, while they are lying on their back in the position they will receive their treatment. Image-guidance is required for the treatment of prostate cancer because the prostate bed shifts position depending on how full the bladder and rectum are. Image-guided radiation therapy has been done at Fletcher Allen Health Care for approximately three years. Most commonly, transabdominal ultrasound images are obtained every day and compared to an ultrasound that was done on the day of treatment planning. Adjustments in radiation field position can be done on a daily basis by comparing these images. Transperineal ultrasound has never been used for image-guidance. We completed two phases of an earlier study and have developed a TPUS device and process that allow us to get clear ultrasound pictures of the prostate gland, and now we would like to explore imaging the prostate bed left after radical prostatectomy.The TPUS has three potential advantages over the transabdominal method we currently use: 1. Transabdominal ultrasound can be a challenge for some men. A full bladder helps us get clearer images, however it is difficult for some men with prostate cancer to comfortably keep a full bladder. It is also particularly difficult to get good images in larger men who have long distances from the skin surface to the prostate bed. TPUS is not dependent on a man having a full bladder and should be less dependent on the size of the man. 2. TPUS images and the planning CT images can be acquired simultaneously. This is not possible with the abdominal probe because it gets in the way of the CT machine. Simultaneous imaging eliminates the possibility of the prostate bed shifting positions during the time between imaging studies. 3. TPUS can be in place and acquire images during patient treatment (the abdominal probe gets in the way of the treatment machine) and may in the future allow us to watch the prostate bed during treatment. If we discover that we can accurately view the prostate bed in real time, TPUS may ultimately allow us to treat even smaller radiation fields and possibly decrease the risk of radiation complications. Patients in this study will be treated for their prostate cancer with the standard image guidance technique used at Fletcher Allen Health Care: transabdominal ultrasound. In addition, one TPUS scan will be acquired at the time of the initial simulation. To summarize, the two objectives of this study are: 1. To determine if TPUS can acquire usable, clinically pertinent IGRT images of the prostate bed. 2. To preliminarily compare TPUS images of the prostate bed to images obtained with CT and TAUS.
This study was designed in two phases: Phase I is designed to confirm that the surgeon is able to perform accurate liver surface registration including standard liver features used as landmarks during a scheduled laparoscopic liver ablation procedure and acquires a level of comfort with the procedure. The surface of the liver will be manually swabbed with the study tracked laparoscopic probe with landmarks noted during data collection. After registration of the liver is obtained, the registration points obtained during this procedure will be evaluated by the surgeon by moving the tracked laparoscopic probe over the liver surface and evaluating the location of the tracked laparoscopic probe displayed on the guidance system three dimensional (3D) image. The surgeon will accept or reject the registration accuracy. The hypothesis is that the surgeon will be able to successfully acquire liver surface registrations with a small learning curve for technique and will be able to proceed to Phase II of the study. Phase II contains the registration process included above but adds the additional process of tracking the ablation probe used to perform tumor ablation by attaching the Pathfinder Multi-Tool adaptor and collecting data showing the location of the ablation probe as tracked and displayed on the Pathfinder three dimensional (3D) image. The surgeon will use ultrasound (US) guidance to locate tumor location during the laparoscopic procedure. The images collected during this process will be recorded by Pathfinder.
Assessment of dietary intake in large, free-living populations is inherently challenging due to the complex nature of human diet. Advancements in traditional methods of dietary assessment (i.e., web-based dietary recalls or records) have aimed at improving data accuracy while reducing participant burden. Further utilizing food recognition technologies to capture real-time food intake may aid in overcoming limitations of existing methods. Keenoa, an artificial intelligence-enhanced, image-assisted tool, is a newly designed mobile application that may facilitate collection of dietary data. Primarily, the investigators will assess acceptability and usability of Keenoa compared with the traditional, web-based Automatic Self-Administered 24-Hour (ASA24) Dietary Assessment Tool in the Framingham Heart Study Third Generation-based cohorts at examination 4. The investigators will also determine the proportion of participants who complete all three days of dietary assessment, either through Keenoa or ASA24. Further, the investigators will relate dietary determinants of glycemic variability (e.g., percent carbohydrate, fiber intake, etc.), obtained from each dietary assessment tool, to the continuous glucose monitor (CGM)-derived outcomes. With a randomized block design, this study will take place as part of the Framingham Heart Study (FHS) glucose study (R01 DK129305). Currently participants from the Third Generation-based cohorts are asked at their fourth examination to wear Dexcom G6 Pro continuous glucose monitor on either their arm or abdomen for a duration of at least 4 days. During this time, participants are asked to complete 3 consecutive days of dietary record through ASA24. For this trial, the investigators will randomize the dietary assessment tool weekly between ASA24 and Keenoa, therefore, depending on the week of administration, participants will be randomized to either a 3 days dietary record via ASA24 or a 3-day dietary record through Keenoa. This trial will last a total of 6 weeks.
Background: - A small brain protein called the metabotropic glutamate receptor subtype 5 (mGluR5) may affect several brain diseases such as autism and depression. Researchers will use 2 radioactive chemicals (\[11C\]SP203 and \[11C\]FPEB) and a research drug (STX107) that can attach to the receptor, to figure out the best way to use positron emission tomography (PET) to see the mGluR5 receptor. They will use scans to monitor where the radioactivity goes. Objectives: - To find the best way to image the mGluR5 receptor in the brain. Eligibility: - Healthy volunteers ages 18 to 55. Design: * All participants will be screened with a medical exam at visit 1. In later visits, they may have a PET scan, when two small tubes are placed under the skin and they lie down in a scanner. They may have an MRI scan, when they lie down in a scanner. * Part 1 participants will have 2 more visits. They will have a PET brain scan using \[11C\]FPEB and will have blood drawn. Then they will have an MRI brain scan. * Part 2 participants will have 1 more visit, with a whole body PET scan using \[11C\]FPEB and blood drawn. * Part 3 participants will have 4 more visits, including 1 overnight stay at a hospital. Over all the visits, they will have 4 PET scans and 1 MRI brain scan. They will receive the research drug and injections of both chemicals. Blood will be drawn during the scans.
All patients will be enrolled in Mozambique and Brazil. They will provide informed consent to use their cervical biopsy and/or LEEP specimens for imaging with DeepDOF prior to sending for standard of care processing and interpretation.
This project aims to develop and evaluate a next-generation photon-counting CT prototype, and assess whether next-generation photon-counting CT--which enables reduced radiation dose, high spatial resolution, and spectral imaging--would facilitate improved diagnostic performance for abdominal, cardiothoracic, musculoskeletal, and neuroimaging.
The design is a single blinded, dual comparative study of ultrasound versus micro-CT/LASCA in one study group. Up to a total of 140 subjects registered will be recruited. Subjects who are treatment planned for extraction of a hopeless tooth and socket augmentation with bone graft and are planned for a dental implant surgery. The socket will be evaluated before the extraction and multi-time points during healing until an implant is placed with various evaluation tools, including ultrasound.
SIS has developed a software technology, based on machine learning and image processing, designed to enhance standard clinical images for the visualization of anatomical structures.
This is a prospective, single arm study, to evaluate the safety, effectiveness and usability of the XACT device. Subjects undergoing CT-guided, minimally invasive percutaneous lung procedures in the interventional radiology suite. eg. core, biopsy, will participate in the study. System and clinical accuracy will be the primary efficacy endpoint. Usability and safety will also be evaluated.
Background: Radiologic images are getting more complex. They are also being used more often. Medical personnel are overwhelmed with data. Computer Aided Detection (CAD) and diagnosis may be able to improve medical care. Researchers want to create and test ways to use CAD. To do this, they want to use data from the Clinical Center s Department of Diagnostic Radiology. Objective: To create algorithms and software that accurately detect and characterize lesions, model anatomy, and monitor diseases on radiologic studies. Eligibility: People of all ages who have radiologic exams stored in the clinical PACS (picture archiving system) of the Clinical Center since July 6, 1953 with no end date. People with target lesions of any kind will be included. Design: This study will use existing data. Participants will include males and females of all ages. They will be chosen by keyword search on NIH databases. The data that is used may include CT, MRI, ultrasound, and other images. It may include a participant s name, date of birth, and date of exam. It may include the name of the doctor, radiologist, and hospital. Data such as age, gender, race, disease, and treatment may be used. Other data from charts or studies may be used. Imaging data of all organs of the body will be studied. Data will be kept in computers and servers. The equipment will be password protected. Printouts will be stored in locked rooms. This study will last 10 years.
A pilot randomized-controlled trial explored the feasibility, acceptability, and efficacy of an inclusive dissonance-based body image intervention called the EVERYbody Project. The professionally delivered EVERYbody Project was evaluated in a universal college student population compared to a waitlist control group through one-month follow-up.
The second trial of the EVERYbody Project explored the efficacy of the inclusive body image intervention when delivered by college peer leaders. The peer-facilitated EVERYbody Project was compared to a video and expressive writing comparison intervention through one-month follow-up.
The purpose of this study is to compare X-ray images obtained using the GM85 digital radiography machine at the standard full dose to X-ray images obtained using the GM85 digital radiography machine along with the Samsung S-Vue system, which is a image post-processing engine that allows images to be obtained using a lower dose. The study also aims to determine the lowest dose of radiation that can be used to get a good, readable x-ray of the chest in pediatric patients using Samsung S-Vue system.
Background: O-GlcNAcase (OGA) is a brain enzyme. It may play a role in brain disorders like Alzheimer s disease. Researchers want to see if a new drug can be used with positron emission tomography (PET) scans to show OGA better. Researchers want to learn more about how it acts in healthy people. Objectives: To test if the new drug \[18F\]OGA-1 can measure its receptor. To determine whether the same results occur when scanning a person twice. Eligibility: Healthy adults age 18 and older who are already enrolled in a separate protocol. Design: Some participants will have 1 whole-body PET scan during one 4-hour visit to the clinic. Some will have 2-3 brain scans (PET and MRI) over 2-3 days. For the PET scan, a needle will guide a thin plastic tube (IV catheter) into an arm vein. A small amount of radioactive chemical will be injected through the catheter. The needle will be removed. Only the catheter will be left in the vein. Another IV catheter may be placed to draw blood. Blood pressure, heart rate, and breathing rate will be measured. Participants will have an electrocardiogram. Participants will lie on a bed that slides in and out of the donut-shaped scanner. The scan will last 2-3 hours. For brain PET scan, participants will wear a plastic mask to keep their head still. For magnetic resonance imaging (MRI) scan, participants will lie on a table. The table slides in and out of the MRI scanner. This is a metal cylinder in a strong magnetic field. Participants will be in the scanner up to 1 hour.
Repeatability and Reproducibility of OCTA Image Quality with the Heidelberg Engineering SPECTRALIS
Background: A radioligand is a radioactive substance that is used to diagnose diseases. A new ligand is called \[11C\]PS13. This has a small amount of radioactivity that can be detected by a positron emission tomography (PET) scan. If this ligand works well in this study, researchers may be able to use it to better understand and diagnose brain disorders. Objectives: To evaluate if \[11C\]PS13 can measure its receptor, which is involved in inflammation. To see if researchers get the same results when scanning a person twice. Eligibility: Healthy people ages 18 and older who are in Protocol 01-M-0254. Design: This study requires three visits of 2-5 hours each. Participants will have 2 PET scans with \[11C\]PS13. A needle will guide a small plastic tube (catheter) into an arm vein. The needle will be removed, leaving only the catheter in the vein. The ligand will be injected through the catheter. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. Participants will wear a molded a plastic mask that fits the head. Another catheter will be put into an artery at the wrist or elbow area. Vital signs will be monitored during the PET scan. Participants will have a test during the PET scan to monitor heart function. Participants will have blood and urine tests. Participants will have 1 magnetic resonance imaging (MRI) scan. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder.
This is a prospective, single-arm study is to evaluate the safety, effectiveness and usability of the XACT device. Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite, e.g., core biopsy, will participate in the summary. Clinical accuracy will be the primary efficacy endpoint. Usability and safety will also be evaluated.
* The purpose of this study is to show that the novel TRAMINER (T(Rho) and Magnetization Transfer and Inversion Recovery) sequence provides at least as good visualization and detection of sub-endocardial scarring, fibrosis, and acute infarction as the current gold standard Inversion Recovery (IR) Turbo-Flash sequence. * The hypothesis is that the TRAMINER sequence has the same or higher sensitivity in detecting small sub-endocardial scarring than the inversion recovery segmented gradient echo sequence known as IR-Turbo Fast low angle shot (IR Turbo-Flash), which is the accepted current gold standard for the detection of myocardial viability.
The use of Ultrasound Guided Regional Anaesthesia (USRA) has increased over the last decade. Theoretically, ultrasound imaging may increase efficacy and safety by allowing visualization of the needle pathway and local anaesthetic spread around the nerve. In addition to knowledge of anatomy and general principles of ultrasonography, USRA requires learning new skills such as image interpretation, needle-beam alignment, and needle trajectory tracking. The hand-eye coordination required during needle advancement requires practice to master because the needle must be properly aligned with the ultrasound probe in order to maintain the needle path in the beam at all times. Adding to the difficulty, hand and needle movements can occur in three axes, but an ultrasound image is seen in only two dimensions. Since the ability to acquire the necessary skills to perform USRA is subjective and not yet validated, it is difficult to recommend a single, effective training pathway. Currently, the only method of supervised training before performing an USRA procedure on an actual patient involves practicing needle insertion in a phantom or cadaver. Studies assessing the impact of learning using these methods are lacking. It is possible that some practitioners may choose alternative one-off learning methods. Such methods are not standardized and are thus difficult to evaluate.
The purpose of this study is to test both user preference and speed of targeting with the use of the Acessa System with Targeting Animation Guidance (TAG).