Radiología

A continuación, se enumeran los ensayos clínicos actuales.

Filtra esta lista de estudios por sede, estatus, etc.

1. A Study of Ticagrelor in the Upstream Setting for Non-ST-Segment Elevation Myocardial Infarction

   Jacksonville, Fla.

   The purpose of this study is to establish a registry that will address the data gap regarding the course of NSTEMI (Non-ST-Elevation Myocardial Infarction) between ED (Emergency Department) arrival and diagnostic angiography in detail, by characterizing and following the ED and peri-ED use of advanced OAP (Oral Anti-Platelet) agents. In addition to exploring ED treatment patterns and success of both ischemic and bleeding risk stratification prior to definition of the coronary anatomy, data generated via the UPSTREAM registry will allow plausible attribution of ischemic and bleeding outcomes to pre-catheterization antiplatelet therapy in the management of NSTEMI. This registry further seeks to demonstrate that contemporary use of upstream ticagrelor is associated with an economically-sound utilization of hospital resources, and smooth transition of care into the outpatient, secondary prevention setting for the first 30 days after hospitalization. Finally, it will allow characterization of patient selection factors and processes for ticagrelor vs alternative OAP agents, carrying out that descriptive comparison through discharge. Patients transferred in to an UPSTREAM hospital are eligible for inclusion, but the timing for OAP agent administration and diagnostic catheterization begin with ED care at the first hospital.

2. MR Elastography of Hydrocephalus

   Rochester, Minn.

   We are doing this research study to develop and test the effectiveness of a new imaging technique called magnetic resonance elastography (MRE). This technique measures the stiffness (mechanical properties) of the brain and cerebral spinal fluid.

3. A Study to Evaluate Noninvasive Ultrasound Elastography of Kidney and Lung in Assessment of Volume Status in ICU Patients

   Rochester, Minn.

   The primary purpose of this study is to assess the feasibility of performing lung and kidney and lung ultrasound elastography among patients with critical illness from different etiologies that could be associated with volume overload.

4. Medical and Resource Facilitation Intervention After Traumatic Brain Injury (MRFI)

   Rochester, Minn.

   The purpose of this study is to determine if there are changes in mild traumatic brain injury (mTBI) and/or repetitive head impacts (RHI) detectible with multiparametric MR Elastography (MRE). The hypothesis is that multiparametric MR Elastography will detect changes in the mechanical properties of human head tissues in patients following head traumas.

    

5. A Study of Lutetium Lu 177 Dotatate (Lutathera®) in Patients with Inoperable, Progressive Meningioma after External Beam Radiation Therapy

   Rochester, Minn.

   The purpose of this study is to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 1 meningioma as measured by 6-month PFS rate, and to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 2 or 3 meningioma as measured by 6-month PFS rate.

    

6. A Study to Evaluate the Safety, Pharmacokinetics and Biodistribution of an Imaging Agent, 18F-OP-801 (18F Hydroxyl Dendrimer) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Healthy Volunteers (HV)

   Jacksonville, Fla.

   The purpose of this study is to evaluate the safety, pharmacokinetics and biodistribution of an imaging agent, 18F-OP-801 (18F Hydroxyl Dendrimer), after intravenous administration to patients with Amyotrophic Lateral Sclerosis (ALS) and Healthy Volunteers (HV)

7. A Study to Evaluate Shared Decision Making for Patients with Minor Head Injury

   Rochester, Minn.

   The primary purpose of this study is to understand the effect of educating patients and encouraging shared decision making on rates of CT scanning in head injured patients by using an already developed app and observing the effect on the health care provider

    

8. A Study to Evaluate the Effects of Distortion Reduction Software for Improving Image Quality in Computed Tomography (CT) Scans

   Rochester, Minn.

   The primary purpose of this study is to evaluate the effectiveness of automatic adaptive iterative metal artifcate reduction (AiMAR) in improving image quality in CT scans of different body parts in patients with different metal implants in terms of artifact reduction and visualization of key anatomic structures.

9. A Study to Investigate the Use of Diaphragm Muscle Ultrasound to Assess the Duration of a Diaphragm Nerve Block

   Rochester, Minn.

   The purpose of this study is to to determine the impact of anesthesia (liposomal bupivacaine) on diaphragm muscle forces using a non-invasive ultrasonographic shear wave elastography (SWE) method.  

10. Evaluation of the Total Kidney Volume AI Algorithm

    Rochester, Minn.

    The natural course of autosomal dominant polycystic kidney disease (ADPKD) is highly variable and typically characterized by progressive enlargement of cysts within the kidneys.  ADPKD is a leading cause of end-stage renal disease.  Recently, a new medication called Tolvaptan has been approved by the FDA to slow progression of ADPKD.  Accurate, MR based kidney volume measurements are the best parameter for following the progression of ADPKD, and are suggested be acquired to measure progression and effects of Tolvaptan.  However, making these slice-by-slice volume measurements can be extremely time consuming when done manually.  The purpose of this work is to evaluate an AI algorithm to make the measurements.  The results of the algorithm will be reviewed by a qualified radiologist familiar with the algorithm’s results.  If the radiologist agrees with the results, kidney volumes (left, right and combined) will be recorded for clinical use.  The usage of the algorithm in this setting (with review by radiologist, and manual correction) is a minimal risk to the patients: a failure of the algorithm will have no impact on treatment and errors will be caught and corrected by the QC process. Because the algorithm will not be used solely for diagnosis or inform treatment without the confirmation of the diagnosis by another, medically established diagnostic product or procedure this study constitutes minimal risk to patients. 

A continuación, se enumeran los ensayos clínicos actuales.

Filtra esta lista de estudios por sede, estatus, etc.

1. A Study of Ticagrelor in the Upstream Setting for Non-ST-Segment Elevation Myocardial Infarction

   Jacksonville, Fla.

   The purpose of this study is to establish a registry that will address the data gap regarding the course of NSTEMI (Non-ST-Elevation Myocardial Infarction) between ED (Emergency Department) arrival and diagnostic angiography in detail, by characterizing and following the ED and peri-ED use of advanced OAP (Oral Anti-Platelet) agents. In addition to exploring ED treatment patterns and success of both ischemic and bleeding risk stratification prior to definition of the coronary anatomy, data generated via the UPSTREAM registry will allow plausible attribution of ischemic and bleeding outcomes to pre-catheterization antiplatelet therapy in the management of NSTEMI. This registry further seeks to demonstrate that contemporary use of upstream ticagrelor is associated with an economically-sound utilization of hospital resources, and smooth transition of care into the outpatient, secondary prevention setting for the first 30 days after hospitalization. Finally, it will allow characterization of patient selection factors and processes for ticagrelor vs alternative OAP agents, carrying out that descriptive comparison through discharge. Patients transferred in to an UPSTREAM hospital are eligible for inclusion, but the timing for OAP agent administration and diagnostic catheterization begin with ED care at the first hospital.

2. MR Elastography of Hydrocephalus

   Rochester, Minn.

   We are doing this research study to develop and test the effectiveness of a new imaging technique called magnetic resonance elastography (MRE). This technique measures the stiffness (mechanical properties) of the brain and cerebral spinal fluid.

3. A Study to Evaluate Noninvasive Ultrasound Elastography of Kidney and Lung in Assessment of Volume Status in ICU Patients

   Rochester, Minn.

   The primary purpose of this study is to assess the feasibility of performing lung and kidney and lung ultrasound elastography among patients with critical illness from different etiologies that could be associated with volume overload.

4. Medical and Resource Facilitation Intervention After Traumatic Brain Injury (MRFI)

   Rochester, Minn.

   The purpose of this study is to determine if there are changes in mild traumatic brain injury (mTBI) and/or repetitive head impacts (RHI) detectible with multiparametric MR Elastography (MRE). The hypothesis is that multiparametric MR Elastography will detect changes in the mechanical properties of human head tissues in patients following head traumas.

    

5. A Study of Lutetium Lu 177 Dotatate (Lutathera®) in Patients with Inoperable, Progressive Meningioma after External Beam Radiation Therapy

   Rochester, Minn.

   The purpose of this study is to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 1 meningioma as measured by 6-month PFS rate, and to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 2 or 3 meningioma as measured by 6-month PFS rate.

    

6. A Study to Evaluate the Safety, Pharmacokinetics and Biodistribution of an Imaging Agent, 18F-OP-801 (18F Hydroxyl Dendrimer) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Healthy Volunteers (HV)

   Jacksonville, Fla.

   The purpose of this study is to evaluate the safety, pharmacokinetics and biodistribution of an imaging agent, 18F-OP-801 (18F Hydroxyl Dendrimer), after intravenous administration to patients with Amyotrophic Lateral Sclerosis (ALS) and Healthy Volunteers (HV)

7. A Study to Evaluate Shared Decision Making for Patients with Minor Head Injury

   Rochester, Minn.

   The primary purpose of this study is to understand the effect of educating patients and encouraging shared decision making on rates of CT scanning in head injured patients by using an already developed app and observing the effect on the health care provider

    

8. A Study to Evaluate the Effects of Distortion Reduction Software for Improving Image Quality in Computed Tomography (CT) Scans

   Rochester, Minn.

   The primary purpose of this study is to evaluate the effectiveness of automatic adaptive iterative metal artifcate reduction (AiMAR) in improving image quality in CT scans of different body parts in patients with different metal implants in terms of artifact reduction and visualization of key anatomic structures.

9. A Study to Investigate the Use of Diaphragm Muscle Ultrasound to Assess the Duration of a Diaphragm Nerve Block

   Rochester, Minn.

   The purpose of this study is to to determine the impact of anesthesia (liposomal bupivacaine) on diaphragm muscle forces using a non-invasive ultrasonographic shear wave elastography (SWE) method.  

10. Evaluation of the Total Kidney Volume AI Algorithm

    Rochester, Minn.

    The natural course of autosomal dominant polycystic kidney disease (ADPKD) is highly variable and typically characterized by progressive enlargement of cysts within the kidneys.  ADPKD is a leading cause of end-stage renal disease.  Recently, a new medication called Tolvaptan has been approved by the FDA to slow progression of ADPKD.  Accurate, MR based kidney volume measurements are the best parameter for following the progression of ADPKD, and are suggested be acquired to measure progression and effects of Tolvaptan.  However, making these slice-by-slice volume measurements can be extremely time consuming when done manually.  The purpose of this work is to evaluate an AI algorithm to make the measurements.  The results of the algorithm will be reviewed by a qualified radiologist familiar with the algorithm’s results.  If the radiologist agrees with the results, kidney volumes (left, right and combined) will be recorded for clinical use.  The usage of the algorithm in this setting (with review by radiologist, and manual correction) is a minimal risk to the patients: a failure of the algorithm will have no impact on treatment and errors will be caught and corrected by the QC process. Because the algorithm will not be used solely for diagnosis or inform treatment without the confirmation of the diagnosis by another, medically established diagnostic product or procedure this study constitutes minimal risk to patients.