Weinan

Researchers are evaluating the diagnostic accuracy of 68Ga-PSMA PET scans compared with enhanced CT scans in detecting metastatic lesions in patients with locally advanced and advanced renal cell carcinoma. The study also aims to determine whether the use of 68Ga-PSMA PET can influence treatment decisions for these patients. This is a prospective, multicenter study focusing on patients with stage III or IV renal cell carcinoma as defined by the 2017 AJCC TNM staging system. Participants will undergo 68Ga-PSMA PET / CT imaging within 6 weeks after their renal cell carcinoma diagnosis. This diagnostic test is being studied for its potential impact on clinical decision-making in renal cancer management. The trial aims to assess the additional diagnostic value of 68Ga-PSMA PET compared to standard CT imaging. During the study, patients will be monitored over a 2-year period to evaluate the diagnostic effectiveness of the 68Ga-PSMA PET. Researchers will collect data on imaging results and observe any changes in treatment plans based on PET findings. Safety and kidney function will also be considered, especially since renal impairment or ongoing hemodialysis are exclusion factors. Participants will provide informed consent before joining the study.

Researchers are investigating the prognostic value of initial staging using prostate-specific membrane antigen (PSMA) positron emission tomography (PET) in men with newly diagnosed, untreated prostate cancer. This study aims to develop a prognostic tool called the PSMA-VISION score to predict progression-free survival (PFS), and to compare this tool with existing prognostic models. The study addresses the current need for clear risk assessment specifically in treatment-nafve patients, as earlier studies included mixed patient groups with varied disease stages and treatment histories, which may limit accuracy. Participants will undergo PSMA PET imaging as part of their initial cancer staging before starting any treatment. The study will collect baseline PSMA PET parameters, such as lesion counts and metastatic stage, alongside clinical and pathological information. These data will be used to create and validate the PSMA-VISION score. The study will follow patients for at least two years to track progression-free survival and overall survival, comparing the new score to established tools like the NCCN risk categories and PPP nomograms. During the study, data will be collected repeatedly every 3 to 6 months and securely stored in a central database. Researchers will monitor progression-free survival over two years and evaluate the predictive accuracy of the PSMA-VISION score. Additional analyses will explore correlations with clinical features and early disease progression. This study plans to enroll approximately 1000 men and will use statistical methods to validate the prognostic value of PSMA PET imaging in this specific patient group.

Researchers are evaluating the effects of two treatments in people with H-type hypertension who have specific genetic types (MTHFR 677 CC or CT), elevated plasma homocysteine levels, and low serum folate. This large, phase 4 clinical trial involves 32,000 Chinese men and women aged 45 to 74 years. The study aims to compare the risk of first ischemic stroke over a five-year period between the two treatment groups. Participants will be divided into groups based on their MTHFR genotype and randomly assigned to receive either amlodipine tablets (5mg once daily) or amlodipine combined with folic acid tablets (5.8mg once daily). The study includes a screening period, a 2 to 4-week run-in phase to check tolerance and compliance to amlodipine, and a five-year randomized treatment phase. Additional blood pressure medications may be added if needed to maintain target blood pressure levels. During the study, participants will have visits every three months for drug distribution and monitoring. Researchers will collect blood samples, conduct clinical evaluations, and gather data on medication adherence and health outcomes. The primary outcome measured is the first occurrence of ischemic stroke by the end of five years. Safety and efficacy will be assessed, with two interim analyses planned at years three and four.

Researchers are studying the effects of three different treatment approaches on the risk of first ischemic stroke in Chinese men and women with hypertension and a specific genetic type called MTHFR 677 TT genotype. This large, phase 4 clinical trial will include 24,000 participants aged 45 to 74, and will compare the impact of amlodipine alone, amlodipine combined with folic acid, and amlodipine combined with folic acid plus 5-methyltetrahydrofolate (5-MTHF). The goal is to evaluate which treatment strategy might better prevent the first ischemic stroke over five years. The study has three main periods: screening, run-in, and randomized treatment. During screening, participants provide consent and undergo interviews, clinical evaluations, and lab tests to confirm eligibility. The run-in period lasts 2 to 4 weeks, where participants take amlodipine (5 mg once daily) to assess tolerance and compliance. After this, eligible participants are randomly assigned to one of three groups: amlodipine only, amlodipine plus folic acid, or amlodipine plus folic acid and 5-MTHF. Treatments are taken orally once daily for five years. Additional antihypertensive medications may be added as needed to keep blood pressure controlled. Participants will visit the research centers every three months for follow-up, medication distribution, and monitoring. Researchers will check blood pressure, collect biological samples, and assess compliance and safety throughout the five-year treatment. The study’s main outcome is the occurrence of a first ischemic stroke by the end of the fifth year. Two interim analyses are planned at years three and four to evaluate ongoing results while maintaining study integrity.

Researchers are evaluating whether delayed PSMA PET imaging improves the detection of clinically significant prostate cancer (csPCa) compared with standard imaging in men suspected of having newly diagnosed prostate cancer. This prospective, multicenter study focuses on treatment-nafve patients and aims to compare the diagnostic accuracy of delayed imaging taken 2-3 hours after injection with standard imaging taken about 60 minutes post-injection. The study addresses the need for more evidence on the added value of delayed imaging in this group of patients. All participants undergo a dual-phase imaging protocol with [^68Ga]Ga-PSMA PET/CT. The first phase is a whole-body scan approximately 60 minutes after the radiotracer injection. The second phase is a delayed pelvic PET-only scan performed 2-3 hours after injection, using the CT data from the first scan for image correction. Each patient acts as their own control, with diagnostic performance compared between the standard and delayed images. Biopsy is performed after imaging to confirm cancer presence and grade. Participants will undergo prostate biopsy using a 12-core systematic approach with additional targeted biopsy as needed. The study measures include comparing the area under the curve (AUC) for maximum standardized uptake values (SUVmax) between delayed and standard imaging to assess which is better at detecting csPCa. Secondary outcomes include defining optimal diagnostic thresholds, evaluating biopsy avoidance potential, assessing changes in clinical management, and exploring performance in patient subgroups. Data monitoring ensures study integrity, and the total participation involves imaging and biopsy procedures.

Researchers are evaluating the consistency of immune response, safety, and lasting immunity of three different batches of the inactivated Enterovirus 71 (EV71) vaccine in children aged 6 to 35 months. This Phase 4, randomized, blinded study involves 1500 healthy children divided into age groups: 6-11 months, 12-23 months, and 24-35 months. The study aims to compare the geometric mean titer (GMT) of neutralizing antibodies against EV71 30 days after the final vaccine dose, along with secondary measures of antibody increase and seroconversion rates. Long-term immunity will be assessed at 12 and 24 months after vaccination, while safety will be closely monitored throughout the study period.

Researchers are evaluating a plasma exosome RNA signature to diagnose clinically significant prostate cancer. This study focuses on men suspected of having this condition, aiming to improve diagnostic methods through a liquid biopsy approach. The main goal is to assess how well plasma exo-RNA can detect clinically significant prostate cancer at the time of prostate biopsy. Participants will undergo a plasma exoRNA-based liquid biopsy as part of the diagnostic process. Men with elevated prostate-specific antigen (PSA) levels and clinical suspicion of prostate cancer through symptoms, digital rectal exam, ultrasound, or MRI are included. The study requires willingness to undergo a prostate biopsy to confirm diagnosis. During the study, researchers will collect blood samples for plasma exoRNA analysis and compare the results to prostate biopsy findings. The primary outcome is the diagnostic accuracy of the plasma exo-RNA panel in detecting clinically significant prostate cancer. Participants will be monitored for safety, and data will be collected at the time of biopsy to evaluate the test's performance.

Researchers are evaluating a new blood test that uses plasma exosomal RNA to predict bone metastasis in men with prostate cancer. This study aims to develop and validate this test as a reliable way to rule out bone metastasis compared to the current standard, PSMA PET imaging, which is expensive and not widely available. The goal is to provide a non-invasive, accurate test that can reduce unnecessary imaging and radiation exposure for low-risk patients. The study is conducted in four phases. Phase 1 involves discovering candidate RNAs through high-throughput sequencing in 250 patients. Phase 2 tests these candidates with a special PCR method in 300 patients to develop a predictive model. Phase 3 validates the model in another 300 patients reflecting typical disease rates, focusing on achieving at least 95% sensitivity. Phase 4 externally validates the model in 150 patients from multiple centers. Blood samples are collected before any prostate cancer treatment or biopsy to avoid contamination. Participants provide blood samples, undergo PSMA PET imaging, and may have prostate biopsies if needed. Researchers analyze RNA levels, imaging results, and clinical data to measure how well the test predicts bone metastasis. The main measure is the test's ability to correctly identify patients without bone metastasis while maintaining high sensitivity. Additional analyses explore correlations with tumor characteristics and clinical outcomes. Participants' data are securely stored and monitored throughout the study.

Liver failure is a serious condition involving severe liver damage due to causes like viral infections, alcohol use, drugs, and blood flow problems. It often leads to damage in other organs and has a high risk of death. This research aims to create a detailed real-world database of hospitalized liver failure patients in China to study their clinical features, infections, muscle loss impact, and improve treatments such as antiviral drugs and artificial liver support. The knowledge gained will support future studies focusing on infections, organ failure in late-stage liver disease, and early warning signs in critically ill patients. The study collects data on three types of liver failure based on timing and liver disease history: acute liver failure with rapid onset and severe brain effects within 2 weeks; subacute liver failure with symptoms appearing between 2 and 26 weeks; and acute-on-chronic liver failure, which occurs suddenly in patients with existing chronic liver disease. Data is gathered through a collaborative network using an electronic clinical system to capture patient information and treatment details. Participants will be monitored for outcomes including survival rates at 28 and 90 days. The study involves detailed data collection on symptoms, lab tests like liver enzymes and blood clotting measures, and clinical status. Researchers will analyze these data to understand disease progression and treatment effects. Safety and clinical condition assessments are included to guide better management of liver failure over time.

Researchers are evaluating the use of serial PSMA PET scans to monitor treatment response in patients newly diagnosed with clinically significant prostate cancer, defined by a Gleason score of 7 or higher. This multicenter, prospective study addresses the need for more sensitive and accurate methods than current PSA tests and conventional imaging to assess early treatment effectiveness and guide therapy decisions over a period of up to two years. Participants will have a baseline PSMA PET/CT scan before starting any prostate cancer treatment. A follow-up PSMA PET/CT scan will be performed either when there is PSA recurrence (defined as a PSA rise of 2 ng/mL or more above the lowest level after radiotherapy or biochemical progression) or within a fixed window of 12 to 24 months after completing treatment for those without recurrence. The same radiotracer and scanner type will be used for consistency. Treatments may include radiotherapy, androgen deprivation therapy, chemotherapy, or combinations. During the study, patients will be monitored through PSMA PET scans to measure changes in the maximum standardized uptake value (SUVmax) and the number of PSMA-positive lesions. Researchers will correlate these imaging changes with clinical outcomes, PSA levels, and conventional imaging results to classify treatment response. Safety and adherence will be tracked, and data will be collected centrally for up to two years to evaluate progression-free survival, time to castration resistance, and the impact of serial PSMA PET on treatment management.