Fu Zhou Shi

Researchers are evaluating the use of 177Lu-JH04, a new radiopharmaceutical targeting fibroblast activation protein FAP, in patients with advanced metastatic tumors that show high FAP expression. This pilot study aims to assess the dosimetry, toxicity, and treatment response of 177Lu-JH04 after other treatment options have been exhausted. FAP is a marker found abundantly in the tumor environment of many cancers, making it a promising target for diagnosis and therapy. Participants are divided into three groups of three patients each, receiving different doses of 177Lu-JH04 intravenously approximately 3.70 GBq 100 mCi, 5.55 GBq 150 mCi, and 7.40 GBq 200 mCi. Each patient receives a single dose of the assigned amount, with up to four cycles of treatment. The study involves careful monitoring of the effects and distribution of the drug in the body. During the study, patients undergo evaluations to measure toxic effects and side effects over about two weeks. Dosimetry assessments of normal organs and tumors are conducted over approximately four weeks. Researchers use imaging and laboratory tests to monitor kidney, blood, and liver function, as well as overall health status. The total participation duration varies according to treatment cycles and follow-up assessments, with safety and response data collected throughout.

Researchers are evaluating a new dual targeting PET radiotracer called 18F-FAPI-Biotin in patients with various types of cancer. This tracer aims to improve tumor detection by targeting both fibroblast activation protein, which is highly expressed in many cancer stromas, and biotin, which is overexpressed in tumor cells but underexpressed in normal cells. The study focuses on assessing the safety, how the tracer distributes in the body, and the radiation dosimetry compared to existing tracers like 18F-FAPI and 18F-FDG. Participants receive an intravenous dose of 148-296 MBq of 18F-FAPI-Biotin. PET imaging is conducted dynamically at multiple time points 3 minutes, 15 minutes, 30 minutes, 60 minutes, and 120 minutes after injection. This allows researchers to observe the tracers pharmacokinetics and dosimetry across different organs and tumors. The study is classified as an early phase 1 trial. During the study, patients undergo PETCT scans at the specified time points following tracer injection. Researchers monitor the dosimetry of normal organs and tumors from immediately after injection up to 120 minutes later. Safety assessments include tracking adverse events for up to one week using standard criteria. The total participation duration includes imaging sessions and safety monitoring to evaluate the tracers distribution and potential side effects.

Researchers are evaluating patients with locally advanced gastric adenocarcinoma CT2-4a N- M0 to study the safety, effectiveness, and feasibility of using indocyanine green ICG near-infrared imaging tracing during 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer. This prospective, single-center, randomized controlled trial compares three surgical approaches to determine if the addition of ICG imaging and 3D visualization improves outcomes, focusing on disease-free survival over three years. Participants will be randomly assigned to one of three groups Group A receives ICG near-infrared imaging with 3D plus ultra high resolution laparoscopic gastrectomy and lymph node dissection Group B receives ICG imaging with ultra high resolution laparoscopic gastrectomy and lymph node dissection Group C undergoes 3D laparoscopic gastrectomy with lymph node dissection without ICG. The study plans to enroll 702 patients and follow them from surgery up to three years to assess long-term outcomes. During the study, patients will undergo surgery according to their assigned group, and researchers will collect data on operation time, number and status of lymph nodes removed, postoperative recovery, complications, immune response, nutritional status, quality of life, and survival rates. Follow-up includes pathology reports shortly after surgery and regular assessments over three years to measure disease-free survival and overall health. The study will also monitor secondary outcomes related to lymph node analysis and patient recovery.

Researchers are studying patients with low-risk intermediate-stage nasopharyngeal carcinoma who have responded well to induction chemotherapy and have undetectable levels of plasma EBV-DNA. The trial compares two doses of radiotherapy targeting a specific low-risk area to evaluate their effects on survival, side effects, and quality of life. This phase 3 randomized study aims to find out if lower-dose radiotherapy can maintain treatment success while reducing toxicities related to treatment. Participants receive either reduced-dose radiotherapy 40.2Gy or conventional-dose radiotherapy 49.2Gy to the low-risk target volume called CTV2. Both groups undergo full-course immunotherapy with the PD-1 monoclonal antibody Tislelizumab, administered every three weeks, totaling 12 courses through induction, radiotherapy, and maintenance phases. Induction chemotherapy using a cisplatin-based regimen is given before radiotherapy. Treatment continues until toxicity, progression, withdrawal, or completion of planned courses. During the study, patients will be monitored for progression-free survival and serious adverse events over three years. Secondary measures include metastasis-free survival, relapse-free survival, overall survival, tumor response rates, and quality of life assessments using standard questionnaires over three years. Safety and effectiveness will be evaluated through imaging, laboratory tests, and clinical evaluations. The study enrollment includes adults aged 18 to 75 years, and the follow-up will provide information on long-term outcomes and treatment impact.

Prostate cancer is a common cancer in men, and this research focuses on a novel imaging agent called 68Ga-AAZTA-NI-093. This agent combines a hypoxia-sensitive nitroimidazole component with a prostate-specific membrane antigen PSMA targeting molecule. The study aims to evaluate the safety, how the agent spreads in the body, radiation dose levels, and its value in diagnosing prostate cancer using PETCT scans. Participants will receive a single intravenous injection of 68Ga-AAZTA-NI-093 at a dose of 111-148 MBq 3-4 mCi. The radiotracer is designed to highlight prostate cancer lesions during PETCT imaging. This is a first-in-human, early phase 1 study to observe these effects and collect imaging data. During the study, patients will be monitored for any adverse events within 7 days after the PETCT scan. Radiation dosimetry data will be collected throughout the study lasting about 3 months. The researchers will assess safety, biodistribution, and diagnostic accuracy, involving imaging and follow-up evaluations to understand the tracers performance and patient tolerance.

Researchers are evaluating the usefulness of 68Ga-DOTANOTA-FAPI-04 positron emission tomographycomputed tomography PETCT for diagnosing primary and metastatic lesions across various cancer types. This early phase 1 interventional study aims to assess how well this imaging method detects tumors in patients with suspected, newly diagnosed, or previously treated malignant tumors. Participants receive a single intravenous injection of the 68Ga-DOTANOTA-FAPI-04 drug followed by a PETCT scan within a specified time frame. The study focuses on quantifying tumor uptake using the maximum standard uptake value SUVmax and calculates diagnostic measures such as sensitivity, specificity, positive and negative predictive values, and accuracy. During the study, participants undergo the PETCT scan after injection and provide informed consent. Researchers measure the standardized uptake value within 30 days and evaluate diagnostic efficacy. The study monitors outcomes related to tumor detection, and participation lasts around the time needed for these assessments, with no ongoing treatment or long-term follow-up specified.

Researchers are evaluating a new imaging agent called 68Ga-FAPI-Biotin in patients with various types of cancer. This tracer targets fibroblast activation protein FAP and biotin, which are highly expressed in many tumors, to improve tumor detection. The study compares 68Ga-FAPI-Biotin with existing imaging agents 68Ga-FAPI and 18F-FDG to assess safety, biodistribution, radiation dose, and diagnostic effectiveness. Participants receive a single intravenous dose of 68Ga-FAPI-Biotin or a comparator tracer 68Ga-FAPI or 18F-FDG to detect tumors using PETCT scans. The doses range from 111 to 148 MBq for 68Ga-FAPI-Biotin and 68Ga-FAPI, or 3.7 MBq per kilogram for 18F-FDG. This early phase 1 trial involves randomized assignment to one of these tracer groups for direct comparison. During the study, participants undergo PETCT imaging to observe tracer distribution and tumor uptake. Researchers measure diagnostic value and tumor standardized uptake values SUV over about three months. Safety and radiation exposure are also monitored. The trial is sponsored by the First Affiliated Hospital of Fujian Medical University and includes adults aged 18 to 90 years with solid tumors confirmed by pathology.

Researchers are investigating the safety, biodistribution, and radiation dosimetry of 68Ga-JH04, a new radiotracer targeting fibroblast activation protein FAP, in patients with various types of cancer. FAP is a marker found on carcinoma-associated fibroblasts, which are common in many epithelial tumors but rare in normal tissues, making it a promising target for cancer diagnostics. This early phase 1 study aims to evaluate how 68Ga-JH04 behaves inside the body and its safety profile in cancer patients. Participants will receive an intravenous dose of 68Ga-JH04 ranging from 148 to 222 MBq. After injection, dynamic PET scans will be performed at multiple time points 3 minutes, 15 minutes, 30 minutes, 60 minutes, and 150 minutes. These imaging sessions will help observe how the tracer distributes and accumulates in tumors and other tissues over time. During the study, participants will undergo PETCT imaging and safety monitoring for up to one week to track any side effects or adverse reactions. Researchers will measure radiation dosimetry and biodistribution based on imaging data collected shortly after injection and up to 150 minutes later. The total duration of participation and detailed assessments are designed to ensure thorough evaluation of the tracers behavior and tolerability.

Researchers are studying 68Ga-JH12, a new radiotracer that targets the CXCR4 receptor, which is commonly found in various malignant tumors. This early phase 1 trial aims to assess the safety, distribution in the body, and radiation dose of 68Ga-JH12 in patients with different types of cancer. Previous studies showed that CXCR4 levels are linked to tumor growth, and 68Ga-JH12 has demonstrated stability and selective tumor accumulation in preclinical tests. Participants will receive an intravenous dose of 68Ga-JH12 ranging from 148 to 222 MBq. Dynamic PET scans will be performed at multiple time points after injectionstarting at 3 minutes and continuing through 150 minutesto observe how the tracer travels and accumulates in normal organs and tumors. This imaging process helps evaluate the tracers dosimetric properties. During the study, participants will be monitored for safety and tolerability for up to one week following tracer administration. Researchers will collect data on how the tracer distributes and the radiation it delivers to normal tissues and tumors. This study is expected to continue until the end of 2025, and participants will undergo scheduled PET imaging and safety assessments as part of their involvement.

Researchers are evaluating a new imaging agent called 68Ga-NI-FAPI, which combines a hypoxia-sensitive nitroimidazole component with targeting of fibroblast activation protein FAP. FAP is found in most epithelial cancer-associated fibroblasts but rarely in normal tissues, making it a promising target for cancer detection. This early-phase study aims to assess the safety, distribution, radiation dose, and diagnostic usefulness of 68Ga-NI-FAPI PETCT scans in patients with various malignant tumors. Participants will receive a single intravenous injection of 68Ga-NI-FAPI at a dose of 111-148 MBq 3-4 mCi. After the injection, patients undergo PETCT imaging to visualize tumor locations and characteristics. This procedure is designed to provide detailed information about tumor presence and behavior by targeting the tumor microenvironment. The study includes only one treatment group, and the imaging is done once following the tracer administration. During the study, participants will be monitored for safety and tolerability for up to one week after the injection. Researchers will also measure the radiation exposure to normal organs and tumors from the time of injection up to 150 minutes post-injection. The total involvement includes the injection, imaging, and follow-up monitoring to evaluate how the tracer behaves in the body and its potential for cancer diagnosis.