Hang Zhou Shi

Myelofibrosis (MF) is a condition involving abnormal growth of fibrous tissue in the bone marrow, along with changes in stem cells and inflammation. Diagnosing MF usually requires a bone marrow biopsy, which is invasive and cannot be repeated frequently to track disease progress. This research aims to evaluate two imaging methods, 18F-FDG PET/CT and 18F-FAPI PET/MRI, to see how well they can detect and monitor systemic fibrosis in MF patients compared to biopsy results, and to explore how imaging findings relate to patient outcomes. The study is designed as a prospective, observational, self-controlled, multi-center trial where participants with MF undergo both 18F-FDG PET/CT and 18F-FAPI PET/MRI scans. These imaging tests will be completed within two weeks of hematologic, cytogenetic, and pathology evaluations. The research does not involve experimental treatments but focuses on assessing the diagnostic effectiveness of these imaging techniques for systemic fibrosis in MF. Participants will undergo imaging scans as part of the study, with vital signs and physical condition monitored to ensure safety. Researchers will collect and analyze imaging data alongside clinical and pathological information to evaluate diagnostic efficiency over an average of two years. The study also includes ongoing follow-up to observe the relationship between imaging results and clinical prognosis for MF patients.

Researchers are evaluating the diagnostic performance and tumor burden detection of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) in patients with neuroblastoma, a cancer that highly expresses norepinephrine transporter (NET). Current imaging methods using 123/131I-MIBG have limitations such as low image resolution and lengthy procedures. The study aims to assess the safety, image quality, and diagnostic accuracy of 18F-MFBG PET, which can be performed quickly after injection and may improve detection of small lesions. In this study, patients with suspected or confirmed neuroblastoma will receive an intravenous dose of 5.55 MBq/kg of 18F-MFBG. After 60 minutes, participants will undergo PET/CT or PET/MR imaging to evaluate tumor presence and burden. The use of 18F-MFBG allows imaging to begin as soon as 0.5 hours after injection without special preparation, potentially offering a more convenient and effective diagnostic option. Participants will be involved in imaging and monitoring procedures lasting an average of 1.5 years to assess the diagnostic efficacy of 18F-MFBG PET. Researchers will evaluate safety profiles, scan image quality, and tumor burden measurements throughout the study period. This ongoing observation aims to provide comprehensive data on the performance of this imaging method in detecting neuroblastoma tumors.

Researchers are evaluating the use of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) imaging in patients with pheochromocytoma, a tumor that highly expresses the norepinephrine transporter. This study aims to assess the diagnostic performance, tumor burden detection, and safety of 18F-MFBG PET imaging, which may offer advantages over traditional imaging methods such as 123/131I-MIBG SPECT that have limitations in resolution, image quality, and procedure time. In this study, patients with suspected or confirmed pheochromocytoma receive an intravenous injection of 5.55 MBq/kg of 18F-MFBG. After 60 minutes, PET/CT or PET/MR imaging is performed without special preparation, allowing for quicker and possibly more accurate tumor visualization. The study will evaluate the safety profile, image quality, and diagnostic usefulness of this imaging method. Participants will be monitored through imaging and pathological diagnosis to correlate positive and negative 18F-mFBG PET/CT or PET/MR findings with treatment effects over an average follow-up period of one year. The study involves clinical assessments including blood pressure monitoring and adherence to study protocols. Safety monitoring includes exclusion of patients with contraindications such as pregnancy or allergy to imaging agents and those unable to cooperate during scanning. Total participation time covers imaging and follow-up through study completion.

Researchers are evaluating the use of 18F-Pentixafor PET imaging to improve the diagnosis, staging, and treatment response assessment of various blood cancers, including multiple myeloma, leukemia, and lymphoma. This imaging method targets the chemokine receptor 4 (CXCR-4), which is often found in high amounts in these cancers and is linked with tumor growth and poor outcomes. The study aims to assess how well this new imaging technique performs compared to current standards, especially for a wider range of hematological tumors. In this study, patients receive an intravenous injection of 18F-Pentixafor at a dose of 55 MBq/kg. After waiting 60 minutes post-injection, they undergo PET/CT or PET/MR scans. This new tracer has advantages such as a longer half-life, better image quality, and higher spatial resolution compared to previous similar tracers. Patients can have the PET imaging without special preparation one hour after the injection. Participants include adults aged 18 to 80 years with suspected or confirmed blood cancers. They will undergo baseline imaging and, if needed, biopsies for diagnosis. Researchers will monitor the diagnostic effectiveness of 18F-Pentixafor PET over about 1.5 years. Throughout the study, assessments include imaging, pathological results, and treatment response evaluations. Safety and compliance with study requirements will also be closely observed.

Adolescent Idiopathic Scoliosis (AIS) is a common spinal deformity in adolescents that requires early diagnosis and accurate assessment to prevent worsening of the condition. Traditional methods like trunk rotation angle and Cobb angle measurements involve X-rays, which expose patients to radiation and may lack sensitivity. This research evaluates a radiation-free, precise method using a 3D depth camera to measure the back height difference, which reflects the degree of trunk deformity caused by scoliosis. The study uses the Kinect v2 depth camera to capture three-dimensional point cloud data of the back without any intervention or treatment. This diagnostic test aims to assess scoliosis by measuring back surface shape and height differences, providing a new way to evaluate spinal deformity safely. Participants will be adolescents aged 10 to 18 years diagnosed with AIS. They will undergo a short-term inpatient stay of 5 days during which the diagnostic assessment takes place. Researchers will measure the back height difference on the first day of admission and monitor the participant's condition without any interventions or treatments. The study focuses on gathering detailed imaging data to improve scoliosis evaluation methods.

Researchers are studying adolescents aged 10 to 18 years with idiopathic scoliosis, a condition involving curvature of the spine. The study evaluates the use of 3D imaging technology with depth cameras to measure back height difference (BHD) and angle of trunk rotation (ATR). The goal is to compare these two measurements and see how well BHD can assess short-term treatment effects after conventional therapies. The study involves three days of tailored exercises guided by X-ray mapping, including 3D therapy, breathing techniques, and spinal manipulation called Tuina. Participants also receive conventional treatments such as massage, exercise therapy, and bracing during a short-term inpatient period lasting five days. Participants will have their back height difference measured on the first and fifth day of admission. Researchers will conduct statistical analyses to check the relationship between BHD and ATR and evaluate the effectiveness of treatments over this short period. The study requires participants to comply with assessment procedures during their inpatient stay.

Researchers are evaluating the effects of reduced-dose radiotherapy (40.2Gy) compared to conventional-dose radiotherapy (49.2Gy) on low-risk target volumes in patients with chemosensitive intermediate-stage nasopharyngeal carcinoma. This phase 3 trial includes patients who have responded well to induction chemotherapy and whose plasma EBV-DNA levels have dropped to zero or below detection limits. The goal is to see if lowering the radiation dose can maintain treatment effectiveness while reducing side effects and improving quality of life. Participants will be randomly assigned to receive either reduced-dose or conventional-dose radiotherapy targeting the CTV2 area, while both groups receive the full course of PD-1 monoclonal antibody immunotherapy. The immunotherapy consists of 12 courses given every three weeks, starting with induction chemotherapy and continuing through radiotherapy and post-radiotherapy maintenance. Induction chemotherapy includes three cycles of gemcitabine and cisplatin or alternative drugs, administered intravenously. Throughout the study, patients will be closely monitored for progression-free survival and the occurrence of significant adverse events over three years. Researchers will assess survival outcomes, side effects, and quality of life differences between the two groups. Regular evaluations include imaging, laboratory tests, and clinical assessments to ensure patient safety and treatment effectiveness during the entire follow-up period.

This will be a confirmatory, prospective, open-label, single-arm, multi-centre study in a Chinese patient population. The study is designed to evaluate the safety, tolerability, sensitivity and specificity of 89Zr-TLX250 Positron Emission Tomography/Computed Tomography (PET/CT) imaging to non-invasively detect Clear Cell Renal Cell Carcinoma (ccRCC). The multi-centre study will be conducted in mainland China in adult patients with Indeterminate Renal Masses (IRM), who are scheduled for partial or total nephrectomy as part of their standard of care. Approximately 82 evaluable adult patients will be recruited from approximately 8 renal cancer care specialist centres with access to state-of-the-art PET/CT imaging in mainland China. The number of enrolled participants may be increased to ensure sufficient confidence in measuring sensitivity and specificity of 89Zr-TLX250 PET/CT imaging. The study involves a single administration of 37 MBq (±10%) of 89Zr-TLX250, containing a mass dose of 10 mg of girentuximab, in mainland Chinese participants (ZIRCON-CP). This is consistent with the confirmatory, prospective, multinational clinical trial ZIRCON (ClinicalTrials.gov ID: NCT03849118). This study consists of seven visits. Imaging will then be conducted 5±2 days post administration. The partial/total nephrectomy will then be performed at institutional discretion any time following the PET/CT imaging visit, but no later than 90 days post administration of 89Zr-TLX250. Histological tumour samples will be prepared and used for histological diagnosis of the renal mass (ccRCC or non-ccRCC) read by a central laboratory. On Day 5±2 post study drug administration, an abdominal PET/CT imaging will be obtained. In patients, in which unexpected evidence for disseminated disease is observed, PET/CT imaging may be extended to complete whole body imaging(vertex of skull to toe) at the discretion of the investigator. Image data analyses will be performed by a central imaging vendor. For participants who were nephrectomised within 28 days post administration, the final study visit will be conducted on Day 42 (±7 days). For participants with nephrectomy between 28 and 90 days post administration, the final study visit will be performed 35 days (±7 days) after surgery. Image data analyses will be performed by a central image core lab. Qualitative visual analysis (presence or absence of localised 89Zr-TLX250 uptake inside or in vicinity of renal lesion, as seen on contrast-enhanced CT or Magnetic Resonance Imaging \[MRI\]), will be used to assess test performance or 89Zr-TLX-250 PET/CT imaging to non-invasively detect ccRCC, using histological results from the central histological reference laboratory as standard of truth. The duration of this study is expected to be about 12 months, with a follow-up of 4 months. The study duration for a single participant will be approximately between 4 - 6 months. No interim analysis is planned for this study.

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are evaluating the safety and effectiveness of rilzabrutinib compared to placebo in adults with active Immunoglobulin G4 Related Disease (IgG4-RD). This Phase 3, randomized, double-blind study aims to measure the time until the first IgG4-RD clinical disease flare during a 52-week treatment period. Additional goals include assessing disease control, flare-free rates, use of glucocorticoid rescue, and monitoring safety through adverse events, laboratory tests, and electrocardiograms. Participants will be randomly assigned to receive either oral rilzabrutinib tablets or placebo for 52 weeks. Glucocorticoids may be used as rescue medication if needed. The study includes a screening period lasting 4 to 6 weeks before treatment begins, followed by the 52-week double-blind treatment phase, and a 2-week follow-up after treatment. An optional open-label extension lasting up to 108 weeks is also available for participants. During the study, participants will attend 16 visits for assessments, which may include clinical evaluations, imaging tests such as CT, MRI, PET, or ultrasound to monitor disease activity, and laboratory tests. Researchers will track time to disease flare and collect data on flare-free rates, safety parameters, and medication use. Participants' vaccination status and contraceptive use will be monitored according to local guidelines, and overall study participation could last up to 60 weeks or longer if joining the extension phase.