Xia Men Shi

Researchers are evaluating the diagnostic effectiveness of 68Ga FAPI PETCT imaging for patients with myelofibrosis, a condition affecting the bone marrow. The study aims to compare this imaging technique with conventional CT scans and to identify different fibrosis grades using bone marrow biopsy as the reference standard. This observational study seeks to determine how well 68Ga FAPI PETCT detects myelofibrosis by measuring sensitivity, specificity, and prediction rates. Participants include those with suspected or confirmed myelofibrosis and patients with primary or secondary myelofibrosis who have not been treated with ruxolitinib. The main intervention is the 68Ga FAPI PETCT scan, which involves lying on a scanning bed for about 20 minutes. The study does not involve treatment but focuses on diagnostic imaging to assess the disease. During the study, participants will undergo the 68Ga FAPI PETCT scan and bone marrow biopsy. Researchers will evaluate diagnostic accuracy by tracking sensitivity, specificity, positive prediction rate, and negative prediction rate over up to 24 months. Participants will be monitored for their ability to complete the imaging and adherence to study protocols, with safety considerations including excluding those with allergies or intolerance to the imaging agent and those with certain health conditions.

Researchers are investigating a new imaging agent called 68Ga-FAPI-LM3, which targets two receptors SSTR2 and FAP and may help in diagnosing diseases with SSTR2 positive expression. This study evaluates the safety, how the agent spreads in the body, and the radiation dose it delivers in healthy volunteers. Additionally, it compares the usefulness of 68Ga-FAPI-LM3 PETCT scans with the standard 18F-FDG PETCT scans in patients with SSTR2 positive diseases. Participants receive a single intravenous injection of both 18F-FDG and 68Ga-FAPI-LM3, followed by PETCT imaging within a specified time frame. Some participants may also have an additional PETCT scan using 68Ga-FAPI-46 for comparison. The study measures how well 68Ga-FAPI-LM3 detects lesions compared to 18F-FDG, using maximum standard uptake value SUVmax and counting the number of positive lesions. During the study, participants undergo PETCT scans to assess lesion uptake and distribution of the imaging agents. Researchers record the number of lesions detected and evaluate diagnostic accuracy within 30 days. Safety and radiation dosimetry are monitored in healthy volunteers. The total duration of participation varies, with the primary outcome assessed at 30 days and secondary outcomes at 2 days after imaging.

Researchers are evaluating a new imaging method using 68Ga-MY6349 PETCT to detect Trop-2 expression in tumor lesions of patients with solid tumors. This study aims to compare the effectiveness of this new PET radiotracer with the standard 18F-FDG PETCT imaging to identify patients who may benefit from Trop-2 targeted imaging. The study is observational and involves patients with various types of malignant tumors, either newly diagnosed or previously treated. Participants receive a single intravenous injection of the 68Ga-MY6349 tracer and then undergo PETCT imaging within a set timeframe. They also undergo standard-of-care imaging with 18F-FDG PETCT either for initial assessment or to detect tumor recurrence. The uptake of the tracer in tumors is measured by the maximum standard uptake value SUVmax and compared visually to the standard imaging results. During the study, researchers will assess the feasibility of using 68Ga-MY6349 PETCT for non-invasive evaluation of Trop-2 expression in tumors. Participants will have both imaging tests and their tumor lesions will be documented and analyzed. The primary focus is on imaging accuracy and tracer uptake within one week. This study is sponsored by The First Affiliated Hospital of Xiamen University and involves adults aged 18 years or older with solid tumors.

This research aims to assess how well 68Ga-NK224 positron emission tomographycomputed tomography PETCT can measure PD-L1 expression in primary and metastatic tumors in people with cancer. It compares PETCT imaging results with tissue analysis through histopathology to better understand tumor characteristics. The study focuses on adults diagnosed with malignant tumors and evaluates imaging technology for its diagnostic value. Each participant receives a single intravenous injection of the imaging agent 68Ga-NK224, followed by PETCT scans to capture images of tumors. Tumor uptake is measured using maximum and mean standardized uptake values SUVmax and SUVmean. The PD-L1 expression in the tumors is then confirmed by examining tissue samples. This evaluation helps compare the imaging results with actual tissue findings. Participants undergo the PETCT imaging and tissue analysis, with data collected to assess the agreement between imaging and histopathological results within 30 days. Researchers also evaluate variability in PD-L1 expression within and between tumors. Participants may be followed for up to 30 days to monitor outcomes. The study involves adults aged 18 to 90 years and includes patients with both newly diagnosed and previously treated cancers.

Researchers are evaluating a new imaging approach using 68Ga-XACP3 PETCT to detect tumor lesions in men with prostate cancer. This study compares the diagnostic performance of 68Ga-XACP3 PETCT with the current standard imaging method, 68Ga-PSMA PETCT, aiming to improve detection of initial or recurrent prostate cancer lesions. The study is led by The First Affiliated Hospital of Xiamen University. Participants receive a single intravenous injection of both 68Ga-XACP3 and 68Ga-PSMA radiotracers, followed by PETCT imaging within a designated time frame. The study records tumor uptake using maximum standard uptake value SUVmax and counts the number of positive tumor lesions detected by both imaging methods. Diagnostic accuracy of 68Ga-XACP3 will be calculated and compared to 68Ga-PSMA. During the study, participants undergo both PETCT scans and clinical assessments to evaluate tumor detection. Researchers will measure diagnostic efficacy over one year, focusing on the number of lesions identified and SUV values. Participants must provide informed consent, and safety and imaging results will be monitored throughout the study period, which runs until October 2027.

Researchers are evaluating BLU-5937, an oral drug, in adults with refractory chronic cough, including unexplained chronic cough, in a randomized, double-blind, placebo-controlled Phase 3 study. The main goal is to assess how BLU-5937 affects 24-hour cough frequency over 24 weeks. This study also monitors safety by tracking adverse events and changes in various health parameters during the treatment period. Participants are randomly assigned to one of three groups BLU-5937 25 mg twice daily, BLU-5937 50 mg twice daily, or a matching placebo taken twice daily. The treatment lasts for 24 weeks, and participants receive their assigned oral medication regularly throughout this time. The study uses a parallel-arm design and includes an extension in China. During the study, participants undergo assessments including cough frequency measurement, vital signs, blood tests for hormones and chemistry, hematology, and ECGs at baseline and Week 24. Researchers also evaluate cough severity and quality of life using questionnaires. Safety is closely monitored by recording adverse events, treatment discontinuations, and laboratory changes. The total participation duration is 24 weeks, with follow-up assessments at specified intervals.

This research aims to understand how thumb-tack needle therapy affects sleep and recovery after surgery in patients who have undergone general anesthesia for breast cancer surgery. The study focuses on improving postoperative sleep quality, preventing sleep disorders, and promoting recovery following surgery. Participants are women aged 18 to 55 years with no history of chronic insomnia or recent use of sedative-hypnotic drugs. Participants in this observational study will undergo thumb-tack needle therapy as part of their postoperative care. The therapys impact will be monitored without assigning different treatment groups. The study will follow patients before and after anesthesia exposure to observe changes in sleep quality and recovery. During the study, researchers will assess sleep quality using the Pittsburgh Sleep Quality Index PSQI one or two days before anesthesia and on days 1, 3, and 7 after anesthesia. Recovery will also be evaluated with the QoR-40 questionnaire on the third day after surgery. The study monitors patient progress to explore the clinical significance of thumb-tack needle therapy in improving postoperative outcomes.

Researchers are evaluating the effectiveness and safety of B001 injection in patients who have neuromyelitis optica spectrum disorder NMOSD and test positive for aquaporin-4 antibodies. This condition involves recurrent attacks affecting the nervous system. The study is a multicenter, randomized, double-blind, placebo-controlled trial conducted in phases II and III to understand how well B001 works and how safe it is for these patients. Participants will receive intravenous doses of either B001 or a placebo on Day 1 and Day 15 during the randomized controlled period. The study includes two groups one receiving B001 injections and the other receiving placebo injections matching B001s schedule. The trial will extend over several years, monitoring patients closely for disease relapse and treatment side effects. During the study, participants will be regularly assessed for the time to their first NMOSD attack, changes in disability status, vision acuity, and opticospinal function. Researchers will also observe the annual relapse rate and document any adverse events. The trial includes safety monitoring for about three years to ensure comprehensive data collection on treatment impact and participant health.

Researchers are evaluating calderasib alone or combined with cetuximab to treat people with advanced solid tumors that have the KRAS G12C mutation, excluding colorectal cancer. This study aims to measure how many participants experience tumor shrinkage or disappearance and compare the responses between the two treatments. It is a phase 2, open-label trial focused on treatment safety and tolerability. Participants will receive calderasib orally with no set limit on treatment cycles. Some participants will also receive cetuximab via intravenous infusion every two weeks. Treatment continues until criteria for stopping the study intervention are met. The trial uses a randomized, parallel design to compare the two experimental arms. Throughout the study, participants will be monitored for tumor response, adverse events, and treatment discontinuations related to side effects. Researchers will also assess progression-free survival, duration of response, and overall survival up to about 76 months. The trial lasts until April 2032, with ongoing safety and efficacy evaluations during this period.

Researchers are studying treatments for locally advanced or metastatic colorectal cancer mCRC that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This trial aims to evaluate if adding the targeted therapies calderasib and cetuximab to the standard chemotherapy regimen mFOLFOX6 can provide better outcomes compared to mFOLFOX6 with or without bevacizumab. The study focuses on the safety and tolerability of these combinations and whether they can help people live longer without their cancer growing or spreading. Participants will be assigned to one of two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil every two weeks. The other group will receive mFOLFOX6 chemotherapy with or without bevacizumab every two weeks, based on the investigators decision. Treatments will continue until certain stopping criteria are met. During the study, participants will be monitored for side effects and treatment tolerance, with regular assessments of cancer progression. Researchers will measure outcomes such as dose-limiting toxicities, adverse events, progression-free survival, and overall survival. Quality of life will also be evaluated through questionnaires. The study may last up to several years, with monitoring continuing for safety and effectiveness throughout the treatment period and follow-up.