Chemotherapy

Gastric cancer is a leading cause of cancer-related deaths in India, and surgery to remove the stomach along with nearby lymph nodes offers the best chance for survival in cases where the cancer has not spread beyond the stomach area. Researchers are studying whether removing more lymph nodes beyond the current standard (D2 lymphadenectomy) to include additional nodes (D3 lymphadenectomy) after chemotherapy provides any extra survival benefit without increasing patient risk. The study aims to clarify the best surgical approach following chemotherapy by comparing these two methods. The trial compares two surgical methods: D2 lymphadenectomy, which removes lymph nodes around the stomach and major blood vessels, and D3 lymphadenectomy, which removes additional lymph nodes near major abdominal vessels. Participants receive chemotherapy before surgery (neoadjuvant chemotherapy) and then undergo one of the two lymph node removal procedures. Experienced surgeons perform both procedures, and the study monitors if removing more lymph nodes affects survival outcomes and patient safety. Participants will be evaluated before surgery and monitored over time to measure overall survival at five years as the primary outcome, along with disease-free survival at two years. The study involves detailed assessments including imaging and pathology to confirm cancer status, and participants must have started chemotherapy prior to surgery. The trial aims to develop clear guidelines on lymph node removal extent after chemotherapy for locally advanced but operable stomach cancer, with follow-up to assess long-term outcomes and safety.

This research aims to understand how patients with cancer respond to COVID-19 vaccination by studying the levels of protective antibodies over time. The focus is on individuals with solid organ malignancies receiving various anti-cancer treatments such as chemotherapy, targeted therapy, and immunotherapy, as well as those who have been disease-free for at least six months. Since cancer patients were excluded from initial vaccine trials, this study seeks to fill knowledge gaps about vaccine safety and effectiveness in this group. Participants include cancer patients who are either undergoing active treatment or are disease-free for six months or more. They are grouped based on their treatment type: chemotherapy, targeted therapy, immunotherapy, or disease-free status. The study involves monitoring antibody trends related to COVID-19 infection and vaccination at multiple time points over a 12-month period. During the study, researchers will collect blood samples to measure neutralizing and spike antibody levels every three months for up to one year. Participants will be followed to track their immune response depending on their cancer treatment and biological aging status. The study will also assess how antibody levels change over time and correlate with different treatments and patient characteristics. Safety and consent are carefully monitored throughout the trial.

Researchers are evaluating the potential usefulness of 18F-FAPI-04 positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging (PET/MR) for diagnosing primary and metastatic cancer lesions, detecting recurrence, and assessing pathological response across various cancer types. The study is observational and aims to assess how well these imaging methods perform compared to standard diagnosis using histopathology and follow-up. Participants with different types of cancer undergo imaging with 18F-FAPI-04 PET/CT and PET/MR scans. The tracer 18F-FAPI-04 is injected into patients before the scans. Tumor uptake is measured by maximum standard uptake value (SUVmax) and tumor to background ratio (TBR). The imaging results are compared using sensitivity, specificity, positive predictive value, negative predictive value, and accuracy to evaluate diagnostic performance. During the study, participants are assessed through these imaging procedures to monitor tumor presence, recurrence, or response to treatment. The primary outcome is the diagnostic performance evaluated over one year. The study includes participants aged 18 to 90 years and involves informed consent and ethical approval. The total duration and follow-up details are based on imaging and clinical evaluations to confirm findings.

Researchers are evaluating a new PET imaging tracer called [18F]FAPI-74 to detect cancer by targeting the fibroblast-activation protein (FAP) found in cancer-associated fibroblasts. This study aims to compare [18F]FAPI-74 PET scans to the standard [18F]-FDG PET scans and other imaging methods like CT or MRI across several cancers including pancreatic ductal adenocarcinoma, cholangiocarcinoma, hepatocellular carcinoma, gastric, bladder, ovarian cancers, pheochromocytoma/paraganglioma, small cell lung cancer, neuroendocrine cancer, mesothelioma, and sarcoma. The study is a phase 2 interventional trial conducted by the National Cancer Institute (NCI). Participants will receive an intravenous dose of [18F]FAPI-74 before undergoing PET/CT imaging about one hour later. They will also have a baseline FDG PET scan within one week. If tumors are detected by [18F]FAPI-74, additional scans using this tracer and FDG may be repeated during routine treatment and if cancer progresses within two years. Those with negative baseline [18F]FAPI-74 scans will not have repeated scans but remain in follow-up. The study involves a single arm where participants undergo both types of PET imaging. During the study, participants will have scans at baseline and potentially at subsequent treatment or progression points. Safety monitoring includes observation for reactions to the tracer up to three days after injection. Researchers will measure the mean number of lesions, standardized uptake values at baseline, post-treatment, and recurrence. Follow-up calls will continue for two years to assess progression-free survival and overall survival. The total participation duration includes imaging visits and two years of follow-up monitoring.

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 evaluating the imaging agent 64Cu-LNTH-1363S in patients with sarcomas or gastrointestinal tract (GIT) cancers to assess its safety, determine the best imaging dose and timing, and compare the imaging results with fibroblast activation protein (FAP) expression in tumor samples. This Phase 1/2a open-label study is divided into two parts and aims to better understand how this radiolabeled agent behaves in the body and how well it highlights tumors that express FAP. In Part 1, six patients with metastatic sarcomas will receive a fixed dose of 64Cu-LNTH-1363S to evaluate its distribution, radiation dose, and optimal imaging window during a one-day intervention, followed by a safety follow-up. In Part 2, approximately 20 patients with non-metastatic, operable sarcomas or GIT cancers scheduled for surgery will receive the optimal dose determined in Part 1 to study the correlation between imaging results and tissue FAP expression. Both parts include detailed cardiac monitoring to assess any changes in heart activity related to the agent. Participants will undergo screening before receiving the imaging agent, followed by serial PET/CT scans at multiple timepoints on the intervention day to measure biodistribution and image quality. Tissue samples collected during surgery will be analyzed to compare with imaging findings. Safety and tolerability will be monitored through follow-up visits, ECGs, and phone contact. The total study duration varies from about three weeks for Part 1 to up to 11 weeks for Part 2, including surgery and post-surgery sample collection.

This research aims to evaluate the use of a new imaging agent called 68Ga-ICAM-1pep in cancer patients undergoing radiotherapy. Researchers want to see if this agent can help predict the abscopal effect, a phenomenon where radiotherapy affects tumors outside the treated area. The study focuses on patients with various cancers such as lung, esophagus, and cervical cancer, and it is an early-phase clinical trial investigating this new approach. Participants will receive a single intravenous dose of 2.96 MBq/kg of 68Ga-ICAM-1pep. PET/CT scans will be performed about one hour after the injection. There are two groups: patients who have not yet received radiotherapy and those who have completed radiotherapy. Imaging will be done before and during radiotherapy to observe tumor responses. During the study, participants will undergo PET/CT scans covering from the head to the upper thigh. Researchers will measure the standardized uptake values (SUVs) of 68Ga-ICAM-1pep before treatment and monitor changes during radiotherapy, about 3 to 4 weeks after it begins. The study includes monitoring for compliance with imaging procedures and overall safety until the study ends in late 2025.

Researchers are evaluating the uptake characteristics of 68Ga-NYM096 PET/CT imaging in various types of tumors, including both primary and metastatic cancer lesions. This prospective, single-center study aims to provide important insights into how different tumors take up this imaging tracer, helping to identify the most promising uses of 68Ga-NYM096 PET/CT for future cancer diagnosis and treatment assessment. Participants will receive a single intravenous dose of 68Ga-NYM096, with the amount adjusted based on body weight. After injection, a whole-body PET/CT scan will be performed approximately 45 to 75 minutes later to capture detailed images of tumor uptake. The study focuses on quantitative analysis of tracer uptake in cancer lesions, measuring factors such as lesion number, maximum standardized uptake value (SUVmax), and tumor-to-background ratio. During the study, participants will undergo the PET/CT imaging procedure and provide informed consent. Researchers will analyze the images to assess tracer uptake characteristics in confirmed tumors. Safety and compliance with study procedures will be monitored. The main outcome is the quantitative assessment of tumor lesions on the 68Ga-NYM096 PET/CT scan, evaluated from study completion to one month after. The study plans to enroll 120 patients with confirmed cancer diagnoses and will follow ethical guidelines throughout the research.

Researchers are studying a new type of scan called FAPI-PET/CT to see how well it detects metastases in patients with advanced gastric cancer. The study aims to find out if this scan can better identify cancer spread, leading to changes in treatment plans such as avoiding unnecessary surgeries or shifting to comfort-focused care. It also evaluates whether the scan causes less burden for patients compared to current methods. Participants will receive the standard care for gastric cancer and undergo one additional FAPI-PET/CT scan, where a small amount of [18F]-FAPI-74 is given intravenously about 60 minutes before a PET/CT scan lasting around 20 minutes. The results from this scan will help doctors decide on further tests or surgery needed. The study monitors changes in diagnosis and treatment decisions based on the scan. During the study, participants will complete questionnaires taking about 4 hours total and spend approximately 2 hours for the extra scan. Researchers will measure outcomes such as changes in treatment intent, diagnostic work-up, scan accuracy, incidental findings, patient burden, quality of life, and safety over about one year. Follow-up includes quality of life assessments and cost evaluations at multiple time points after staging.

Researchers are studying a new imaging agent called [18F]FPyQCP in a Phase 1/2 trial to evaluate its safety, radiation exposure, and how well it detects several cancers: colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, invasive lobular breast cancer, and epithelial ovarian cancer. This study involves multiple centers and aims to provide preliminary diagnostic information on these conditions using advanced imaging techniques. Participants in this study will receive an injection of [18F]FPyQCP followed by a positron emission tomography (PET)/computed tomography (CT) scan during a designated imaging visit. The study includes two groups: Cohort A focuses on radiation dosimetry up to 360 minutes post-injection, and Cohort B evaluates diagnostic performance over a follow-up period of up to 42 days. Women of childbearing potential and sexually active men must use effective contraception during the study. During the trial, participants will undergo various assessments including imaging scans, safety monitoring for adverse events from screening through 48 hours after injection, and follow-up procedures to assess diagnostic accuracy. Researchers will carefully measure radiation exposure and imaging results to determine how well [18F]FPyQCP identifies cancer presence. The study runs until January 2028, with participants monitored closely to ensure safety and gather comprehensive data.