Rochester

Researchers are evaluating the safety and effectiveness of elenestinib BLU-263 combined with symptom directed therapy SDT compared to placebo plus SDT in adults with indolent systemic mastocytosis ISM whose symptoms are not well controlled by SDT alone. This randomized, double-blind, placebo-controlled Phase 23 study includes multiple parts to assess different doses and durations of elenestinib treatment, including an open-label extension for participants finishing earlier phases. The study also enrolls participants who have previously received an approved selective KIT inhibitor and includes pharmacokinetic groups. Participants receive oral elenestinib or placebo once daily alongside SDT, which is personalized based on individual symptom management needs. Part 1 focuses on short-term treatment lasting up to 12 weeks, while Part 2 extends treatment to approximately 48 weeks. Part 3 and other parts allow treatment for up to about 5 years. The study monitors participants through these phases to evaluate how elenestinib affects symptoms, disease markers, and safety over time. During the study, participants undergo regular assessments of symptoms using the ISM-Symptom Assessment Form ISM-SAF, laboratory tests including serum tryptase and KIT D816V allele levels, bone marrow evaluations, and quality of life measures. Researchers track adverse events and changes in disease-related factors at various points up to 5 years. This thorough monitoring helps measure treatment effects and safety over both short and long-term periods, with total participation lasting several years depending on the study part.

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

Researchers are evaluating the 24-hour effect on intraocular pressure IOP reduction of a fixed combination of netarsudil and latanoprost compared to latanoprost alone in adults aged 18 years and older with open angle glaucoma or ocular hypertension. This study is a phase 4, double-masked, paired-contralateral trial aimed at understanding how these treatments compare when applied in each eye of the same subject. Participants will receive netarsudil-latanoprost fixed combination eye drops in one eye and latanoprost eye drops in the other eye, each dosed once daily at night for 14 consecutive days. The total participation time may extend up to 10 weeks to include any necessary washout from prior treatments. This design allows direct comparison of the two treatments within the same individual. During the study, participants will undergo various eye examinations including visual field testing, optical coherence tomography, and dilated fundus exams to assess IOP changes. Researchers will monitor IOP changes over 24 hours, focusing on mean IOP reduction, nighttime and daytime IOP variations after two weeks of treatment. Safety and adherence will be tracked throughout, with total study involvement lasting up to 10 weeks including screening and washout periods.

This research registry focuses on individuals suspected or confirmed to have 24-hydroxylase deficiency, a rare condition related to the CYP24A1 gene mutation. The goal is to collect and maintain detailed data about this disease to help improve understanding and support future research efforts. This is the first and only registry of its kind, aiming to assist clinicians and scientists at Mayo Clinic in their work on diagnosis and treatment. Participants in this registry will be those who have undergone genetic testing for CYP24A1 mutation and meet specific clinical criteria related to urinary stone disease, kidney calcification, bone disease, and certain blood test results, or are family members of such patients. The registry does not involve treatment but collects ongoing health information yearly to track disease symptoms and progression. During the study, researchers will gather data from medical records, genetic tests, and clinical evaluations to establish and maintain the registry. Participants health outcomes and disease development will be monitored yearly to improve knowledge about 24-hydroxylase deficiency. The registry participation duration extends as long as data is collected, with results shared to support medical advances and patient care.

Researchers are evaluating a new MRI pulse sequence called 3D DL oZTEo to detect bone erosions in the hands of patients with inflammatory arthritis. The study aims to validate this technique against current standard methods like radiography and conventional MRI, as these structural changes are important for diagnosis and treatment decisions in rheumatic conditions. This is an interventional study conducted at Mayo Clinic. Participants will have the FDA-approved oZTEo MRI pulse sequence added to their routine hand MRI scan. The oZTEo images will be anonymized and processed using a deep learning algorithm developed by GE Healthcare. This additional sequence is assessed alongside the standard MRI to compare its ability to detect bone erosions. During the study, researchers will analyze MRI scans with and without the 3D DL oZTEo sequence to determine the presence and number of bone erosions in the hand. Participants must have recent hand radiographs confirming erosions and are scheduled for hand MRI as part of their clinical care. The study measures outcomes on the day of imaging and monitors the accuracy of erosion detection.

Researchers are evaluating a new ultrasound imaging method to diagnose breast masses in adult women. This study aims to assess the effectiveness of 3D multimodal ultrasound imaging in detecting breast tumors and improving diagnostic accuracy, led by the Mayo Clinic. The trial focuses on women who have solid breast lesions and are scheduled for biopsy as part of their clinical care. Participants will undergo 3D multimodal ultrasound imaging using two types of diagnostic ultrasound scanners the GE Logiq E10 clinical ultrasound scanner, which captures 2D B-mode, Doppler, and shear wave elastography images, and the Verasonics research scanner, which provides 3D B-mode imaging, microvessel imaging, and shear wave elastography. This imaging is performed before the participants have a clinically indicated breast tumor biopsy. During the study, researchers will collect imaging data and assign a Breast Imaging Reporting and Data System BI-RADS score at baseline as the primary outcome measure. Participants are women aged 18 years or older with solid breast lesions of 3 mm or larger. Safety monitoring and follow-up details are not specified, but participation involves undergoing the ultrasound imaging and biopsy procedures as part of standard clinical care. The trial is expected to conclude by the end of 2026.

This trial studies a new three-dimensional ultrasound 3D-US imaging technology designed to evaluate lymph nodes in patients with breast cancer. The study aims to optimize the 3D-US performance, assess its ability to differentiate benign from malignant lymph nodes, and compare it with conventional two-dimensional ultrasound methods for locating clipped lymph nodes in patients undergoing neoadjuvant chemotherapy. Participants receive the 3D-US imaging as part of the study. Those with a lymph node clip placed and undergoing chemotherapy will have the clipped lymph node imaged before surgery. This is an early phase I diagnostic study focused on improving imaging techniques for breast cancer lymph node evaluation. During the study, participants undergo 3D-US imaging to assist radiologists in diagnosing whether lymph nodes are benign or malignant. The primary outcome measure is the accuracy of lymph node diagnosis by radiologists over a period of up to two years. The study involves imaging before surgery, with ongoing evaluation of the diagnostic performance of the new technology throughout the study duration.

Researchers are evaluating the safety and effectiveness of two drugs, 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA, in men with prostate cancer that has spread and no longer responds to hormone-lowering treatments. This study focuses on cancers that express a protein called PSMA and aims to find safe and effective dosing while monitoring how the drugs behave in the body. Participants will go through different study phases. In the initial dosimetry phase, a single dose of 200 MBq of 64Cu-SAR-bisPSMA is given. Later phases involve receiving multiple doses of 64Cu-SAR-bisPSMA or 67Cu-SAR-bisPSMA, with doses and number of administrations varying by phase and participant group. The dose escalation phase tests increasing doses of 67Cu-SAR-bisPSMA, followed by a cohort expansion phase with up to six doses of the recommended 67Cu-SAR-bisPSMA dose. During the study, participants will undergo PETCT scans to track drug distribution and dosimetry within 48 hours of dosing. Researchers will measure prostate-specific antigen PSA levels and radiographic responses over up to five years to evaluate treatment effects. Safety will be monitored through assessments of vital signs, ECGs, laboratory tests, and recording any adverse events. The total study duration can extend up to five years for long-term follow-up.

Researchers are studying whether the PET radiotracer 68Ga-FAPI-46 can detect fibrostenosing Crohns disease in the small bowel. This early phase 1 case-control study aims to understand if early or developing fibrosis areas take up the tracer, which binds to fibroblast activation protein FAP. Participants with small bowel Crohns disease will be grouped based on imaging results to compare tracer uptake between those with and without strictures. Participants will receive a PETCT scan using the radioactive tracer Gallium-68-labeled fibroblast activation protein inhibitor-46 68Ga-FAPI-46, administered intravenously at a dose of 5 mCi 10%. Cases include participants with small bowel strictures or probable strictures, while controls include those without strictures but may have other disease features. This design allows researchers to investigate different stages of fibrosis development in Crohns disease. During the study, participants will complete the PETCT scan with 68Ga-FAPI-46. Researchers will monitor the completion rates of these scans over an average of 2 years. Participants will be evaluated through imaging and clinical assessments related to their Crohns disease status. Safety, tracer uptake patterns, and disease characteristics will be documented throughout the study period.

Researchers are evaluating whether a three-dimensional 3D-printed external breast prosthesis can improve patient-reported outcomes for breast cancer patients who have had a mastectomy without undergoing surgical reconstruction. Breast cancer often requires mastectomy, and while reconstruction is common, some patients choose not to or are not candidates. Traditional external prostheses may lack comfort and proper fit, so this study is assessing a customized 3D-printed prosthesis made using 3D imaging and computer-aided design CAD. This approach aims to create a better fitting prosthesis which could enhance patient satisfaction and emotional well-being. During the study, patients undergo a CT scan and have a patient-specific external breast prosthesis model developed using CAD. Measurements are taken for the 3D-printed prosthesis during screening. Participants then receive a fitting and are given the 3D-printed external breast prosthesis. The study involves procedures such as CAD development, measurements, prosthesis fitting, and receiving the customized prosthesis. Questionnaires are also administered to assess patient-reported outcomes. Participants will complete assessments at baseline and at 1, 3, 6, and 12 months, including surveys about satisfaction with appearance, emotional well-being, comfort, fit, and overall satisfaction with the 3D-printed prosthesis. Study procedures include surface scanning with temporary skin markers, standardized photography, and follow-up surveys. The study aims to monitor these outcomes over one year to evaluate the impact of the personalized prosthesis on patient experiences after mastectomy.