Fu Zhou Shi

Researchers are evaluating the safety, dosimetry, and treatment response of 177Lu-JH04, a new radiopharmaceutical targeting fibroblast activation protein (FAP) in patients with advanced metastatic tumors that express FAP. FAP is a marker found on cancer-associated fibroblasts in over 90% of malignant tumors, making it a promising target for therapy. This early phase 1 pilot study includes patients whose tumors show high FAP expression confirmed by 68Ga-FAPI PET/CT after other treatment options have been exhausted. Participants are divided into three groups of three patients each, receiving increasing doses of 177Lu-JH04: approximately 3.70 GBq (100 mCi), 5.55 GBq (150 mCi), and 7.40 GBq (200 mCi). Each patient receives a single intravenous injection of the assigned dose up to 4 cycles. The study assesses how the drug distributes in the body, its toxicity, and the tumor response to the treatment. During the study, patients undergo regular monitoring for toxic effects and side effects throughout the treatment period, averaging about two weeks. They also have evaluations including imaging scans and laboratory tests to assess tumor response and organ function. Safety and tolerability are closely followed to understand the treatment's impact on patients with advanced metastatic FAP-positive tumors.

Researchers are evaluating a new imaging agent called 18F-FAPI-Biotin, which targets fibroblast activation protein (FAP) and biotin in various cancers. This early-phase study aims to observe the safety, distribution in the body, and radiation exposure of 18F-FAPI-Biotin in patients with different types of solid tumors. The study also compares 18F-FAPI-Biotin with existing imaging tracers 18F-FAPI and 18F-FDG to assess its targeting ability, detection sensitivity, and diagnostic effectiveness. Participants will receive an intravenous dose of 18F-FAPI-Biotin between 148 and 296 MBq. The study involves PET/CT scans using this novel dual targeting tracer. Researchers will perform head-to-head comparisons with scans using 18F-FAPI or 18F-FDG to evaluate dosimetric characteristics and how well the tracer detects tumor lesions. During the study, patients will undergo imaging and monitoring from right after tracer injection up to 120 minutes post-injection to measure radiation doses to normal organs and tumors. Safety and biodistribution will be observed, and diagnostic performance will be evaluated through these scans. The study includes patients aged 18 to 80 with various solid tumors and requires histopathological confirmation and informed consent for participation.

Researchers are studying patients with locally advanced gastric adenocarcinoma (CT2-4a N-/+ M0) to assess the safety, effectiveness, and feasibility of using indocyanine green (ICG) near-infrared imaging combined with 3D plus ultra high resolution laparoscopic gastrectomy and lymph node dissection for treating gastric cancer. This is a prospective, single-center, randomized controlled phase 3 trial designed to compare different laparoscopic techniques for gastric cancer surgery. The study includes 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 near-infrared imaging with ultra high resolution laparoscopic gastrectomy and lymph node dissection; Group C undergoes 3D laparoscopic gastrectomy with lymph node dissection without ICG imaging. Each group will enroll 234 patients, with treatments performed during the surgical procedure. Enrollment is expected to be completed within two years. Participants will be followed from surgery through postoperative pathology reporting (about two weeks after surgery) for secondary outcomes, with primary outcomes assessed by three-year disease-free survival rates. Researchers will monitor safety, efficacy, and clinical outcomes through this follow-up period, which extends to three years after the last patient enrollment, concluding around December 2028.

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.

Prostate cancer is a common cancer in men characterized by high levels of prostate specific membrane antigen (PSMA) on cancer cells. Researchers are assessing a new radiotracer called 68Ga-AAZTA-093 that targets PSMA to study its safety, how it spreads in the body, radiation exposure, and ability to help diagnose prostate cancer. This early phase 1 study compares 68Ga-AAZTA-093 with two other PSMA-targeting radiotracers, 68Ga-PSMA-11 and 68Ga-PSMA-617, in the same group of patients. Participants will receive one intravenous injection of 111-148 MBq (3-4 mCi) of 68Ga-AAZTA-093 to image prostate cancer lesions using PET/CT scans. They will also receive an injection of 68Ga-PSMA-11 or 68Ga-PSMA-617 tracer within one week for comparison. Both radiotracers are administered once during the study to evaluate their imaging capabilities and radiation dosimetry. During the study, patients will undergo PET/CT imaging to track the distribution of the radiotracers and assess any safety concerns within 7 days after the scans. The study monitors the diagnostic value of the new tracer along with radiation exposure and overall safety. Participation includes signing consent and completing imaging within a week, with the total study duration based on these procedures.

Prostate cancer is a common cancer in men, and this study evaluates a new imaging agent called 68Ga-AAZTA-NI-093. This agent combines a molecule that targets prostate-specific membrane antigen (PSMA) with a component sensitive to low oxygen levels in tumors. The research aims to assess the safety, how the agent spreads in the body, the radiation dose patients receive, and its ability to detect prostate cancer through PET/CT scans. Participants will receive a single intravenous injection of 68Ga-AAZTA-NI-093 at a dose of 111-148 MBq (3-4 mCi). This tracer is used to image prostate cancer lesions using PET/CT technology. The study is an early phase 1 trial and focuses on first-in-human use of this novel radiotracer. During the study, researchers will monitor participants for any adverse events within 7 days after the PET/CT scan. They will evaluate the distribution of the tracer in the body, measure radiation exposure, and assess the diagnostic value of the PET/CT images. Participants must provide written consent and will be followed closely for safety and imaging outcomes throughout their involvement.

Researchers are evaluating a new radiotracer called 68Ga-DOTA-NI-FAPI04, which targets fibroblast activation protein (FAP) found in cancer-associated fibroblasts of many epithelial tumors. This early phase 1 study observes the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT scans in patients with various types of solid tumors and compares its imaging results with those of other tracers, 68Ga-FAPI and 18F-FDG PET/CT. Participants receive an intravenous injection of a tracer dose of 68Ga-DOTA-NI-FAPI04, ranging from 111 to 148 MBq (3-4 mCi), to detect tumors through PET/CT imaging. Comparisons are made with the administration of either 68Ga-FAPI or 18F-FDG at specified dosages. Each participant undergoes one dose of the tracer during the study period. During the study, patients undergo PET/CT scans to assess tumor detection using the different tracers. Researchers measure the diagnostic value of 68Ga-DOTA-NI-FAPI04 on average over three months. Safety and effectiveness are monitored throughout the study, which includes patients aged 18 to 80 years with confirmed solid tumors and available tissue diagnosis.

Researchers are studying a new imaging agent called 68Ga-FAPI-Biotin, which targets fibroblast activation protein (FAP) and biotin, both highly expressed in various cancers. This dual targeting tracer is being evaluated for its safety, distribution in the body, and radiation dose, as well as its ability to detect tumors compared to existing imaging agents 68Ga-FAPI and 18F-FDG. The study focuses on patients with different types of solid tumors to better understand this tracer's potential for cancer diagnosis. Participants receive an intravenous injection of a single dose of 68Ga-FAPI-Biotin, ranging from 111 to 148 MBq (3-4 mCi), to detect tumors using PET/CT scans. For comparison, patients also receive injections of either 68Ga-FAPI or 18F-FDG at specified doses. The study involves head-to-head comparisons of these tracers to assess their imaging characteristics and diagnostic effectiveness. During the study, researchers monitor the biodistribution, pharmacokinetics, and radiation dosimetry of 68Ga-FAPI-Biotin over approximately three months. Patients undergo PET/CT imaging sessions with each tracer. The main outcome measured is the diagnostic value of the imaging agents. Safety and radiation exposure are carefully observed throughout the study period to evaluate the potential benefits and risks of this new tracer.

Researchers are studying 68Ga-JH04, a new radiotracer that targets fibroblast activation protein (FAP), which is found in the tumor environment of many cancers. This protein is highly present in over 90% of epithelial malignant tumors but limited in normal tissues, making it a promising target for cancer imaging. The study aims to assess the safety, how the tracer spreads throughout the body, and the radiation dose patients receive when using 68Ga-JH04 in various cancer types. Participants receive an intravenous dose of 68Ga-JH04 ranging from 148 to 222 MBq. This early phase 1 study focuses on measuring the distribution and radiation dosimetry of the tracer in patients with different solid tumors. The treatment involves a single injection followed by imaging to track the tracer's accumulation in tumors and other tissues. During the study, patients will be monitored for safety and tolerability for up to one week after the injection. Researchers will evaluate how the tracer behaves in the body, including its stability and ability to bind specifically to tumors. This includes collecting data on radiation exposure and any side effects. The overall goal is to better understand the tracer's properties to potentially improve cancer diagnosis and staging.

Researchers are evaluating the safety, biodistribution, and radiation dosimetry of a new radiotracer called 68Ga-JH12, which targets the C-X-C motif chemokine receptor 4 (CXCR4). This receptor is highly present in patients with malignant tumors and is linked to tumor cell proliferation. Unlike previous agents, 68Ga-JH12 has shown high stability, specific tumor accumulation, and selectivity in preclinical studies, making it promising for imaging various cancers. Participants will receive an intravenous dose of 68Ga-JH12 between 148 and 222 MBq. The study involves PET/CT imaging to observe how the radiotracer distributes in the body and to measure radiation exposure levels. This early phase 1 trial focuses on patients with different types of solid tumors, aiming to understand the dosimetric characteristics of 68Ga-JH12. During the study, participants will be monitored for safety and tolerability for up to one week following the dose administration. Researchers will collect data on how the radiotracer behaves in the body, including its accumulation in tumors and overall radiation dose. The study includes patients between 18 and 80 years old and involves informed consent and histopathological confirmation of cancer type.