A Phase 3, Open-Label, Multicenter Study of I-124 evuzamitide as an Imaging Agent for the Diagnosis of Cardiac Amyloidosis using Positron Emission Tomography Computed Tomography (PET/CT)

Date Added
January 28th, 2025
PRO Number
Pro00141834
Researcher
Jan Griffin

List of Studies

Keywords
Drug Studies, Heart
Summary

This study is testing a new radiotracer dye called I-124 evuzamitide in patients with suspected cardiac amyloidosis. Cardiac amyloidosis occurs when proteins misfold and deposit as amyloid fibrils in the heart. The build up of these fibrils (proteins) cause the heart to enlarge due to wall thickening so the heart has to work harder. Over time, this can lead to heart failure. I-124 evuzamitide is given during a Positron Emissions Tomography/ Computed Tomography (PET/CT) scan to help diagnose cardiac amyloidosis. It is not a treatment for amyloidosis. I-124 evuzamitide is considered investigational meaning it is not approved for commercial use by the Food and Drug Administration. (FDA). It will be given one time through an intravenous line, meaning in the vein before the PET/CT scan.

This study will last about 60 days and include 4 visits. The final study visit will take place at day 30 but medical records will be reviewed up to day 60. In addition to receiving I-124 evuzamitide, participants will also receive potassium iodide, an approved medication, by mouth to take for 3 days to protect the thyroid gland from the radiotracer I-124 evuzamitide, electrocardiogram (ECG), bloodwork and questionnaires.

Institution
MUSC
Recruitment Contact
Ellie Cutright
843-876-5011
cutrighe@musc.edu

Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical Trial

Date Added
February 12th, 2025
PRO Number
Pro00140879
Researcher
James Roberts

List of Studies


Keywords
Children's Health, Obesity, Pediatrics
Summary

iAmHealthy CPG aims to provide valuable insights into tailored obesity interventions for rural populations through dual interventions: iAmHealthy, a family-based behavioral group program delivered via telehealth, and Healthy Clinic, which enhances clinic processes through provider prompts and skills training. The study employs a stepped wedge design, allowing clinics to transition from a control condition to the intervention in staggered, randomized waves.

The study will evaluate the effectiveness of iAmHealthy compared to a control group, assess the impact of the Healthy Clinic intervention on obesity management at the practice-level, and explore the combined effects of both interventions. Quality improvement concepts and processes will be covered through various topics during monthly virtual learning collaborative meetings once your practice enters the intervention phase. Key outcomes will include changes in children's BMI, physical activity, dietary behaviors, and sleep quality.

Institution
MUSC
Recruitment Contact
Shannon Cabaniss
843-732-1839
smw207@musc.edu

Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical Trial

Date Added
February 12th, 2025
PRO Number
Pro00140879
Researcher
James Roberts

List of Studies


Keywords
Children's Health, Obesity, Pediatrics
Summary

iAmHealthy CPG aims to provide valuable insights into tailored obesity interventions for rural populations through dual interventions: iAmHealthy, a family-based behavioral group program delivered via telehealth, and Healthy Clinic, which enhances clinic processes through provider prompts and skills training. The study employs a stepped wedge design, allowing clinics to transition from a control condition to the intervention in staggered, randomized waves.

The study will evaluate the effectiveness of iAmHealthy compared to a control group, assess the impact of the Healthy Clinic intervention on obesity management at the practice-level, and explore the combined effects of both interventions. Quality improvement concepts and processes will be covered through various topics during monthly virtual learning collaborative meetings once your practice enters the intervention phase. Key outcomes will include changes in children's BMI, physical activity, dietary behaviors, and sleep quality.

Institution
MUSC Health Marion Medical Center
Recruitment Contact
Shannon Cabaniss
843-732-1839
smw207@musc.edu

A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo

Date Added
March 7th, 2025
PRO Number
Pro00140123
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This study aims to evaluate the effectiveness of ruxolitinib cream compared to a placebo (vehicle) cream in treating vitiligo in children aged 2 to 12 years. The vehicle cream looks identical to the ruxolitinib cream but contains no active medication. By comparing these two treatments, researchers hope to determine whether ruxolitinib is more effective than the placebo in improving facial and body vitiligo symptoms. This study could provide important insights into new treatment options for young children affected by this condition.

Institution
MUSC
Recruitment Contact
Kennedy McLeod
843-792-4091
mcleodke@musc.edu

3D CTA Fusion for Prostate Artery Embolization: A Randomized Controlled Trial

Date Added
April 1st, 2025
PRO Number
Pro00140426
Researcher
Stephen Stringfellow

List of Studies

Keywords
Men's Health
Summary

This research study is focused on evaluating the effectiveness of a new imaging technique for a procedure called Prostate Artery Embolization (PAE), which is used to treat an enlarged prostate. The study compares two groups of patients: one group receives PAE with advanced imaging called 3D CTA fusion, and the other group receives PAE using the standard imaging method. The goal is to determine if using 3D CTA fusion can make the procedure faster, reduce the amount of radiation exposure, and decrease the need for contrast dye during the procedure. By studying these two groups, researchers hope to identify ways to make PAE safer and more efficient​

Institution
MUSC
Recruitment Contact
Derek Groskreutz
8432437260
groskreu@musc.edu

Randomized Controlled Trial of MAGIcTouch - Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease

Date Added
April 1st, 2025
PRO Number
Pro00137869
Researcher
Adam Tanious

List of Studies

Keywords
Vascular
Summary

The purpose of this research is to evaluate the efficacy of a new investigational Sirolimus coated balloon device in the treatment of insufficient blood flow of legs (peripheral arterial disease, PAD).

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse (CAMPERR)

Date Added
April 9th, 2025
PRO Number
Pro00143358
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

This study aims to develop a new blood test to detect and identify many different types of cancer, using a special technique that looks at tiny changes in your DNA. Some participants will be followed over time to see if this method can also find leftover cancer cells (after treatment), and if it could warn if the cancer comes back. However, this test still under development, so there are no results reported back to participants. The goal is to create a reliable tool that one day could help doctors diagnose and monitor cancer(s) more effectively.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse (CAMPERR)

Date Added
April 9th, 2025
PRO Number
Pro00143358
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

This study aims to develop a new blood test to detect and identify many different types of cancer, using a special technique that looks at tiny changes in your DNA. Some participants will be followed over time to see if this method can also find leftover cancer cells (after treatment), and if it could warn if the cancer comes back. However, this test still under development, so there are no results reported back to participants. The goal is to create a reliable tool that one day could help doctors diagnose and monitor cancer(s) more effectively.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

A prospective, multicenter clinical trial of the TricValve® Transcatheter Bicaval Valve System in subjects with severe tricuspid regurgitation.

Date Added
April 22nd, 2025
PRO Number
Pro00143868
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart, Surgery
Summary

This study is enrolling subjects with tricuspid regurgitation, which is what occurs when the tricuspid heart valve on the right side of the heart does not close properly and blood leaks backwards. Over time this can lead to symptoms like shortness of breath and fluid build up in the legs, abdomen, and lungs. This study involves a new investigational device called the TricValve® Transcatheter Bicaval Valve system to treat the leaky valve. Investigational means it is not approved for commercial use by the Food and Drug Administration. (FDA) This study will last about 5 years and include about 11 visits. Study related procedures include physical exams, right heart catheterization (an invasive procedure to check pressures inside the heart), echocardiograms (ultrasound test of the heart), CT scan, blood work, questionnaires, hall walk test and procedure to place the device. Risks include those related to the device and procedure such as infection, failure of the device, worsening of your symptoms or other cardiac complications. There are also risks associated with study testing such as radiation risks, blood draw risks, loss of confidentiality and unknown risks. There is potential benefit to you and to others in the future from what is learned from this study.

Institution
MUSC
Recruitment Contact
Natalie Drain
843-876-5037
drain@musc.edu

CONQUEST: Platform Clinical Study for Conquering Scleroderma: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2b Platform Clinical Study to Evaluate the Safety and Efficacy of Investigational Products in Participants with Interstitial Lung Disease Secondary to Systemic Sclerosis

Date Added
May 13th, 2025
PRO Number
Pro00135916
Researcher
Faye Hant

List of Studies


Keywords
Autoimmune disease, Drug Studies, Rare Diseases, Scleroderma
Summary

The CONQUEST study is a clinical trial for people with systemic sclerosis associated interstitial lung disease (SSc-ILD). The goal of the research study is to help potentially uncover new SSc-ILD treatment options. The study is sponsored by The Scleroderma Research Foundation and is currently working with 2 pharmaceutical companies to provide the investigational medications (Amlitelimab, a subcutaneous injection/shot and BI 1015550/Nerandomilast, a tablet taken by mouth). Study participation involves a main study which is collecting general information about your scleroderma health and well being and at the same time, a treatment study that is specific to the investigational drug that you are assigned.

An investigational or study drug is not approved by The US Food and Drug Administration. It can only be used in a research study like this one. In this study the ID will be compared with a placebo (dummy drug). The placebo will be a look like the ID but does not have any study drug in it. The comparison with the placebo helps to determine whether the effects seen in your body is because of the ID or not. This is a randomized study, meaning that you will be assigned by chance (like flipping a coin) to receive either the study drug or placebo. The study is double-blinded study, meaning you and your study doctor will not know if you are taking a study drug or placebo but you will know what treatment study you are assigned (Treatment Study A with Amlitelimab or Treatment Study B with BI 1015550/Nerandomilast).

Participation in the overall study will be approximately 60 weeks (4 weeks
Screening, 52 weeks Treatment Period, and 4 weeks Follow-up with visits to the MUSC main campus. Study visits are much like the visits that you have with our Rheumatologist as part of your routine care such as: blood draw, urine collection, physician-led assessments of your disease (for example physical exam and skin thickness testing), tests to assess your pulmonary function and health (Pulmonary Function Test (PFT) and High Resolution Computed Tomography (HRCT)), electrocardiogram, as well as being asked to complete surveys/questionnaires.

Compensation is available with participation.

Institution
MUSC
Recruitment Contact
Miranda Irvin
843-792-8613
sclerodermaresearch@musc.edu



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