Advanced Imaging Techniques

This research evaluates the use of the echOpen probe in managing patients referred to the Jean Verdier Rapid Diagnosis Unit UDR to see how it affects the time to diagnosis. The study focuses on improving diagnosis speed and accuracy and reducing the need for extra examinations. It is divided into three phases, each involving the introduction of the echOpen probe in different care settings, including hospital units, multi-professional health centers, and a Health Bus. The studys intervention involves using the echOpen probe for a systematic 4-point echoscopy examination that covers organs like the liver, spleen, lymph nodes, thyroid, and depending on symptoms, lung, kidney, bladder, and abdomen. The probe is CE marked and will be used alongside standard care. Each phase begins with training doctors to use the probe, followed by patient inclusions and testing the probes impact on care organization and diagnosis processes. Participants will undergo the echoscopy examination and complete satisfaction questionnaires alongside their physicians. Researchers will measure outcomes such as time to diagnosis, the number of patients with direct access to biopsy, and reduction in additional exams. Patient and physician satisfaction with the echOpen probe will also be assessed. The study includes follow-up visits up to two months after inclusion, with a total inclusion period lasting about 16 months.

Researchers are studying whether 68Ga-FAPI PETCT scans can be a new effective way to evaluate axillary lymph nodes after neoadjuvant treatment in women with breast cancer. This observational study focuses on patients who have clinically positive axillary lymph nodes and have undergone treatment before surgery. The goal is to understand if this imaging method can better detect remaining cancer in lymph nodes compared to traditional methods. Participants will have a 68Ga-FAPI PETCT scan after completing at least three courses of neoadjuvant therapy and before surgery. This scan is being evaluated for its ability to detect residual disease in the lymph nodes without being affected by blood glucose levels, offering potentially clearer imaging. The study will observe participants without altering their treatment, focusing on this imaging test. During the study, participants will undergo the PETCT scan, and researchers will track how well the scan predicts residual cancer in the lymph nodes after treatment. They will measure the sensitivity and specificity of the scan up to the time of surgery, and follow participants for up to three years to see how well the scan predicts invasive disease-free survival and overall survival. Participants usual care will continue throughout the study, which starts in August 2024 and ends in June 2026.

This research aims to assess the diagnostic value of a new PETCT imaging probe called 68Ga-C1, which specifically targets the CAIX protein found in about 95% of clear cell renal cell carcinomas. The study will also investigate the safety, tolerability, and radiation exposure from 68Ga-C1. Researchers will compare this new imaging method with the standard 18F-FDG PETCT scan in Chinese patients who have unclear kidney masses or confirmed clear cell renal cell carcinoma. Participants with suspected or confirmed clear cell renal cell carcinoma will receive an intravenous injection of 68Ga-C1 at a dose of 0.05-0.10 mCikg, followed by PET imaging. They will also undergo a whole-body 18F-FDG PETCT scan within one week. This approach allows direct comparison of the two imaging techniques in the same patients. During the study, participants will have PETCT scans with both imaging agents to evaluate tumor detection and characteristics. Researchers will measure diagnostic accuracy, radiation dosimetry, and quantitative uptake of 68Ga-C1 over one year. Correlation with tumor pathology will also be assessed. The study will monitor safety and tolerability throughout, with the overall participation lasting at least one year.

Researchers are investigating the diagnostic potential of a new molecular imaging probe called gallium 68-labelled fibroblast-activation protein inhibitor 68Ga-FAPI in detecting various malignant tumors. Fibroblast-activation protein FAP is commonly found in cancer-associated fibroblasts within tumor tissue and plays a role in tumor growth and spread. This study aims to confirm the advantages of 68Ga-FAPI over traditional imaging methods like 18F-fluorodeoxyglucose 18F-FDG PETCT, which can sometimes give false positive or negative results in certain cancers. Participants who have undergone whole-body 18F-FDG PETCT scans for suspected or confirmed malignancies, particularly tumors with low FDG uptake such as glioma, hepatocellular carcinoma, renal cancer, gastrointestinal cancer, and peritoneal metastases, will receive a whole-body 68Ga-FAPI PETCT scan within one to four weeks. The 68Ga-FAPI is injected intravenously with a dose based on body weight, and imaging is performed 20 to 60 minutes after injection. This interventional study evaluates how well 68Ga-FAPI PETCT can diagnose and stage malignant tumors. During the study, participants will undergo the 68Ga-FAPI PETCT scan and be monitored for diagnostic sensitivity and specificity over three years. Researchers will also assess the prognostic value of FAPI PET parameters up to one year post-treatment, evaluate therapeutic response within one week after completion of therapy, and explore correlations between PET imaging and histopathological biomarkers within four weeks of the scan. The study includes informed consent and follow-up assessments to understand the imaging methods overall effectiveness in managing cancer.

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 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 the use of 68Ga-grazytracer PET imaging to help diagnose pseudoprogression in lung cancer patients after immunotherapy. Pseudoprogression is difficult to distinguish with current clinical methods, which often require follow-up observations that may not meet clinical needs. This study aims to assess the effectiveness and feasibility of this novel imaging agent, which targets granzyme B to show the activity of cytotoxic T cells in tumor areas. This observational study uses 68Ga-grazytracer PETCT scans to visualize and semi-quantitatively measure granzyme B concentration in lung cancer lesions that have enlarged or developed new lesions after immune checkpoint inhibitor treatment. The study follows patients for 4-8 weeks, up to a maximum of 12 weeks, to evaluate the diagnostic performance of this imaging method in detecting pseudoprogression. Participants will undergo PETCT imaging and be monitored over the follow-up period to assess changes and outcomes. Researchers will collect data on diagnostic accuracy and safety during this time. The study includes adult lung cancer patients aged 18 to 75 years who meet specific clinical criteria and have a life expectancy of at least six months. Total participation duration varies with the follow-up period, and patient compliance with study requirements is monitored throughout.

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.

Researchers are studying a new imaging agent called 68Ga-PSFA, which targets two receptors, PSMA and FAP, to improve the diagnosis of diseases that express these markers. This early phase 1 trial aims to evaluate the safety, distribution in the body, and diagnostic potential of this PET radiotracer for detecting lesions in patients with PSMA or FAP positive diseases. Participants will receive a single intravenous injection of 68Ga-PSFA. This administration is designed to allow imaging of disease sites expressing the PSMA or FAP markers. No placebo or comparison group is involved, and the study focuses on one treatment arm where all patients receive the investigational imaging agent. During the study, participants will be monitored for diagnostic effectiveness within 15 days after injection. Researchers will assess how well the agent detects lesions and track any side effects or safety concerns. The trial is open to adults aged 18 and older who meet certain disease criteria and consent to participate, with no maximum age limit specified.

Researchers are evaluating a new dual-target imaging agent called 68Ga-RM26-RGD for PETCT scans in patients with breast, brain, and prostate cancers that express specific receptors GRPR and integrin v3. This study aims to improve tumor detection by comparing this agent with conventional 18F-FDG and single-target imaging agents, addressing limitations of current imaging methods in detecting tumors with low 18F-FDG uptake or variable receptor expression. Participants will undergo PETCT scans using intravenous injections of 68Ga-RM26-RGD and one of the comparator agents 18F-FDG, 68Ga-RM26, or 68Ga-RGD within a two-week period. The dosages for these agents are approximately 1.8-2.2 MBqkg. Each patient receives scans with both agents to compare imaging performance directly. During the study, researchers will assess diagnostic accuracy and dosimetry of 68Ga-RM26-RGD over about one year. Participants will have multiple PETCT scans and related evaluations to monitor uptake of the imaging agents in tumors. The study includes safety and diagnostic performance monitoring throughout the participation period.