الأشعة

بالأسفل التجارب السريرية الحالية.

غربل قائمة الدراسات هذه بالموقع والحالة وغيرها.

1. 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. 

2. A Study to Evaluate MR of CSF Dynamics

   Rochester, Minn.

   The purpose of this study is to evaluate changes in CSF dynamics (e.g., velocity, flow rate) between patients with normal pressure hydrocephalus and healthy controls, as well as patients with other dementia disorders.

3. A Study to Compare Two Ultrasound-based Methods for Assessing Diaphragm Muscle Function

   Rochester, Minn.

   The purpose of this study is to assess and compare the utility of ultrasonographic shear wave elastography (SWE) method as compared to “ABCDE” thickening ratio and fraction method in assessing diaphragm function.

4. In Vivo Development of Phosphorus Magnetic Resonance Imaging Technology

   Rochester, Minn.

   The goal of this study is to evaluate and optimize our existing phosphorus MRI head coil and imaging sequence on healthy human volunteers. 

5. A Phase I/II, open-label, multi-center trial of [177Lu]Lu-NeoB in combination with capecitabine in adult patients with GRPR+, ER+, HER2- metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibito

   Rochester, Minn.

   The purpose of this study is to determine the recommended doses (RD) and dosing regimens of [ 177Lu]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibitor. In the phase II part, to evaluate the preliminary antitumor activity of two different doses/regimens of [177Lu]Lu-NeoB in combination with capecitabine (dose optimization).

6. Retrospective Review of Radiological Findings of Uterine Leiomyosarcoma in Comparison with Those of Atypical Leiomyoma

   Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to retrospectively review the imaging findings of the uterine leiomyosarcoma and compare with those of atypical leiomyoma.

7. Clinical Evaluation and Deployment of a Clinical PET/MR System with a Data Registry

   Jacksonville, Fla.

   The purpose of this study is to assess and deploy a new PET/MR platform following the same quality control method as was done at other Mayo Clinic sites, i.e. Rochester and Arizona.
   
   The secondary purpose is to initiate a data registry for the PET/MR studies allowing us to capture some basic information about the indications, findings, and relevant imaging and non-imaging biomarkers for the studies conducted. This will allow us to see trends in utilization as well as create preliminary data to inform future (IRB approved) investigations.

8. Improving the Quality of Magnetic Resonance Imaging (MRI) Examinations

   Rochester, Minn.

   The purpose of this research study is to improve the quality of Magnetic Resonance Imaging (MRI) examinations.

9. EF-41/KEYNOTE D58: Phase 3 Study Of Optune Concomitant With Temozolomide Plus Pembrolizumab In Newly Diagnosed Glioblastoma

   Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

   This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS).

بالأسفل التجارب السريرية الحالية.

غربل قائمة الدراسات هذه بالموقع والحالة وغيرها.

1. 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. 

2. A Study to Evaluate MR of CSF Dynamics

   Rochester, Minn.

   The purpose of this study is to evaluate changes in CSF dynamics (e.g., velocity, flow rate) between patients with normal pressure hydrocephalus and healthy controls, as well as patients with other dementia disorders.

3. A Study to Compare Two Ultrasound-based Methods for Assessing Diaphragm Muscle Function

   Rochester, Minn.

   The purpose of this study is to assess and compare the utility of ultrasonographic shear wave elastography (SWE) method as compared to “ABCDE” thickening ratio and fraction method in assessing diaphragm function.

4. In Vivo Development of Phosphorus Magnetic Resonance Imaging Technology

   Rochester, Minn.

   The goal of this study is to evaluate and optimize our existing phosphorus MRI head coil and imaging sequence on healthy human volunteers. 

5. A Phase I/II, open-label, multi-center trial of [177Lu]Lu-NeoB in combination with capecitabine in adult patients with GRPR+, ER+, HER2- metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibito

   Rochester, Minn.

   The purpose of this study is to determine the recommended doses (RD) and dosing regimens of [ 177Lu]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibitor. In the phase II part, to evaluate the preliminary antitumor activity of two different doses/regimens of [177Lu]Lu-NeoB in combination with capecitabine (dose optimization).

6. Retrospective Review of Radiological Findings of Uterine Leiomyosarcoma in Comparison with Those of Atypical Leiomyoma

   Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to retrospectively review the imaging findings of the uterine leiomyosarcoma and compare with those of atypical leiomyoma.

7. Clinical Evaluation and Deployment of a Clinical PET/MR System with a Data Registry

   Jacksonville, Fla.

   The purpose of this study is to assess and deploy a new PET/MR platform following the same quality control method as was done at other Mayo Clinic sites, i.e. Rochester and Arizona.
   
   The secondary purpose is to initiate a data registry for the PET/MR studies allowing us to capture some basic information about the indications, findings, and relevant imaging and non-imaging biomarkers for the studies conducted. This will allow us to see trends in utilization as well as create preliminary data to inform future (IRB approved) investigations.

8. Improving the Quality of Magnetic Resonance Imaging (MRI) Examinations

   Rochester, Minn.

   The purpose of this research study is to improve the quality of Magnetic Resonance Imaging (MRI) examinations.

9. EF-41/KEYNOTE D58: Phase 3 Study Of Optune Concomitant With Temozolomide Plus Pembrolizumab In Newly Diagnosed Glioblastoma

   Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

   This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS).