Xia Men Shi

Researchers are evaluating the diagnostic effectiveness of 68Ga FAPI PET/CT imaging in patients with primary myelofibrosis, a condition that affects the bone marrow. The study aims to compare this imaging method with conventional CT scans to identify fibrosis grades and improve diagnosis accuracy. Bone marrow biopsies will serve as the reference standard for assessing diagnostic performance, including sensitivity, specificity, and prediction rates. Participants will undergo 68Ga FAPI PET/CT scans, which are designed to detect fibrosis in the bone marrow. The study includes patients with suspected or confirmed myelofibrosis as well as those not treated with ruxolitinib, a common medication for this condition. The imaging process requires participants to lie on the scanning bed for about 20 minutes. During the study, researchers will monitor diagnostic outcomes for up to 24 months, measuring sensitivity, specificity, positive prediction rate, and negative prediction rate of the imaging test. Participants will provide informed consent and follow the study protocol, with ongoing assessments to evaluate the imaging's ability to diagnose and grade myelofibrosis effectively.

This research investigates a new PET imaging tracer called 68Ga-FAPI-LM3, which targets dual receptors SSTR2 and FAP. The study evaluates its safety, how it spreads in the body, and radiation dosage in healthy volunteers. It also explores how well 68Ga-FAPI-LM3 PET/CT detects lesions in patients with diseases that express SSTR2, comparing its performance to the standard 18F-FDG PET/CT imaging. Participants receive intravenous injections of both 18F-FDG and 68Ga-FAPI-LM3, followed by PET/CT scans within specified timeframes. Some participants may also undergo additional imaging with 68Ga-FAPI-46 PET/CT for comparison purposes. Lesion uptake is measured by maximum standard uptake value (SUVmax), and the number of positive lesions detected by each imaging method is recorded and compared. Throughout the study, participants will have both imaging tests to assess disease presence and characteristics. Researchers will analyze diagnostic accuracy by comparing the two PET/CT methods. The main outcome measured is diagnostic efficacy over 30 days. Safety and radiation exposure are monitored in healthy volunteers to understand the tracer's behavior and potential clinical use.

This research aims to develop a noninvasive method using 68Ga-MY6349 PET/CT imaging to detect Trop-2 expression in tumor lesions among patients with various solid tumors. Trop-2 is a cell surface antigen, and this study evaluates 68Ga-MY6349 as a promising new radiotracer for imaging different cancer types. The goal is to identify which patients may benefit from Trop-2 targeted imaging. Participants receive a single intravenous injection of the 68Ga-MY6349 tracer and undergo PET/CT imaging. These images are compared to standard-of-care 18F-FDG PET/CT scans taken for initial cancer assessment or recurrence detection. Tumor uptake is measured by SUVmax, and the number of positive tumor lesions seen by both imaging methods is recorded to assess diagnostic accuracy. Participants will have both imaging scans as scheduled, and researchers will analyze the results to evaluate the feasibility of 68Ga-MY6349 PET/CT for noninvasive Trop-2 detection across cancer types. The study includes a short follow-up period of about one week to complete imaging and data collection. Safety and informed consent procedures are followed throughout the process.

Researchers are evaluating the potential usefulness of 68Ga-NK224 positron emission tomography/computed tomography (PET/CT) to assess PD-L1 expression in patients with primary or metastatic tumors. This imaging technique is compared with standard histopathological results to determine its accuracy in detecting PD-L1 in cancer lesions. The goal is to understand how well 68Ga-NK224 PET/CT can diagnose PD-L1 expression in various malignant tumors. Participants with cancer undergo a 68Ga-NK224 PET/CT scan for initial tumor assessment. The uptake of the tracer in tumors is measured using maximum and mean standard uptake values (SUVmax and SUVmean). Following imaging, tumor lesions are analyzed using histopathology to confirm PD-L1 expression. Researchers compare the quantitative PET/CT data with the histopathological findings to evaluate the diagnostic effectiveness of this imaging method. During the study, participants receive the PET/CT scan and provide tumor samples for pathological analysis. The main outcome measured is the agreement between PET/CT imaging results and histopathological PD-L1 expression within 30 days. The study includes adults aged 18 to 90 years who have malignant tumors and are scheduled for the PET/CT scan. Safety and diagnostic accuracy are monitored throughout the study period.

Researchers are evaluating a new imaging technique called 68Ga-XACP3 PET/CT for detecting tumor lesions in patients with prostate cancer. This method targets acid phosphatase 3 (ACP3) and is being compared to the current standard imaging approach, 68Ga-PSMA PET/CT, to assess its ability to identify tumors either at initial diagnosis, recurrence suspicion, or metastasis detection. Participants receive a single intravenous injection of both the standard radiotracer (68Ga-PSMA) and the new 68Ga-XACP3 tracer. They then undergo PET/CT scans to capture images of their tumors. Tumor uptake is measured using the maximum standard uptake value (SUVmax), and the number of positive tumor lesions detected by each imaging method is recorded and compared to determine diagnostic accuracy. During the study, patients undergo both imaging tests close together in time. Researchers analyze the images visually and quantitatively to compare the two methods. The primary outcome is the diagnostic effectiveness over one year. Participants must provide informed consent and are monitored throughout the imaging procedures. The study focuses on adult men with prostate cancer or suspected recurrence, with ages ranging from 18 to 80 years.

Researchers are studying the effects of thumb-tack needle therapy on sleep and recovery after general anesthesia in patients who have undergone breast cancer surgery. The study aims to understand how this therapy might improve sleep quality, prevent sleep disorders after surgery, and aid in recovery. The focus is on women aged 18 to 55 years with no history of chronic insomnia or recent sedative use. The trial involves patients undergoing breast cancer surgery under general anesthesia who meet specific health criteria. Participants receive thumb-tack needle therapy as part of the follow-up treatment to evaluate its impact on postoperative sleep and recovery. The study does not specify additional treatment groups or comparators. Participants will have their sleep quality assessed using the Pittsburgh Sleep Quality Index before anesthesia and on days 1, 3, and 7 after anesthesia. Researchers will monitor recovery progress and any postoperative complications or pain. The study tracks these outcomes closely to determine the clinical significance of the thumb-tack needle therapy in improving postoperative recovery and sleep.

Researchers are evaluating the safety and effectiveness of a drug called B001 injection in patients who have neuromyelitis optica spectrum disorder (NMOSD) and test positive for aquaporin-4 antibodies. This study is a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial designed to compare B001 with a placebo in this patient population. The goal is to assess whether B001 can reduce the time to the first NMOSD attack during the study period. Participants will receive either an intravenous dose of B001 or a matching placebo on Day 1 and Day 15 during the randomized controlled period (RCP). Both treatment groups follow the same dosing schedule to evaluate the effects of B001 compared to placebo over approximately 48 weeks. During the study, participants will be closely monitored through regular assessments to track any NMOSD attacks and overall health. Researchers will measure the time to the first NMOSD attack as the primary outcome. Safety and any side effects of the treatment will also be evaluated throughout the study period. Participants are expected to complete all required tests and follow study procedures as part of their involvement.

Researchers are studying whether calderasib alone or combined with cetuximab can treat advanced solid tumors in people who have the KRAS G12C mutation. This phase 2, open-label trial aims to find out how many participants respond to these treatments and to compare their safety and tolerability. Participants receive calderasib by mouth and cetuximab through intravenous infusion. The study includes people with locally advanced or metastatic solid tumors other than colorectal cancer, who have already undergone standard treatments. The trial monitors response and side effects over time as participants receive either calderasib alone or in combination with cetuximab. During the study, participants undergo regular assessments to measure tumor response and track any side effects or adverse events. Researchers record how many people experience treatment-related side effects and how many stop treatment due to these effects. The study follows participants for up to approximately 76 months to assess long-term outcomes and safety.

Researchers are evaluating new treatment options for adults with locally advanced or metastatic colorectal cancer that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This study compares the safety and effectiveness of adding calderasib and cetuximab, both targeted therapies, to a standard chemotherapy regimen called mFOLFOX6. The goal is to see if this combination can help patients live longer without their cancer growing or spreading compared to current treatments that may include mFOLFOX6 with or without bevacizumab. The study has two parts. It involves treatment with calderasib taken as an oral tablet, cetuximab given according to standard procedures, and mFOLFOX6 chemotherapy combining oxaliplatin, leucovorin/levofolinate calcium, and 5-fluorouracil. Some participants may receive bevacizumab or a bevacizumab biosimilar as part of the comparison. The treatments are given following approved dosing schedules. This design allows researchers to assess the safety and tolerability of these drug combinations in treating this type of colorectal cancer with the KRAS G12C mutation. Participants will be monitored for side effects, treatment tolerability, and cancer progression over a period that may last up to about 44 months. Researchers will track outcomes such as how many participants experience dose-limiting toxicities or adverse events, how many stop treatment due to side effects, and progression-free survival time. Assessments include health evaluations, laboratory tests, and imaging to observe cancer status. This long-term follow-up aims to understand both safety and effectiveness of the treatment combinations.

Researchers are conducting a phase III, randomized, open-label, multicenter clinical trial to evaluate the safety and effectiveness of TQB2102 for injection compared to the chemotherapy regimen TCbHP in the neoadjuvant treatment of patients with HER2-positive breast cancer. The study aims to assess key outcomes including the total physiological complete response (tpCR), breast pathological complete response (bpCR), overall response rate (ORR), event-free survival (EFS), invasive disease-free survival (IDFS), overall survival (OS), and adverse events (AEs). Participants will receive either TQB2102, a HER2 dual-antibody drug conjugate, or the TCbHP chemotherapy combination consisting of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin. Treatment is given before surgery as part of the neoadjuvant approach. The study compares these two treatment regimens to determine their relative effectiveness and safety in this setting. During the study, participants will be monitored for response to treatment and side effects over a period of up to 26 months from the start of the study. Evaluations by an Independent Review Committee will include measuring the rate of total physiological complete response. Additional assessments will track other clinical outcomes and adverse events. Participants must comply with study requirements, including surgery after neoadjuvant therapy if appropriate, and safety will be closely observed throughout the trial.