Colon Polyp

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.

Colorectal cancer is a common and serious disease that often develops from precursor growths called adenomatous polyps. This study evaluates the long-term effects of berberine hydrochloride, a drug previously shown to reduce recurrence of these polyps after removal. Researchers aim to see if the protective effects of berberine continue for up to six years after patients stop taking the medication. The study observes patients who were part of an earlier trial where they received either berberine or a placebo. It compares the recurrence rates of colorectal adenomas and other types of polyps at multiple intervals: within the first year, between one and three years, and between three and six years after stopping the drug. This retrospective follow-up helps assess berberine's long-term preventive effects. Participants will be monitored through medical records to track the recurrence of colorectal adenomas and other polyps over six years. Researchers will analyze outcomes such as the rate of traditional adenoma recurrence and the incidence of hyperplastic and serrated polyps. This study provides important information about the lasting impact of berberine on colorectal polyp recurrence after endoscopic removal.

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 PET/CT scans with the standard 18F-FDG PET/CT scans in patients with SSTR2 positive diseases. Participants receive a single intravenous injection of both 18F-FDG and 68Ga-FAPI-LM3, followed by PET/CT imaging within a specified time frame. Some participants may also have an additional PET/CT 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 PET/CT 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 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.

This clinical trial is investigating sedation methods during colonoscopic polypectomy procedures. It aims to compare the effects of remimazolam besylate combined with sufentanyl versus propofol combined with sufentanyl on circulatory and respiratory stability. The study also evaluates the incidence of hypotension and respiratory depression, as well as the overall sedation success and recovery times in adult patients. Participants are randomly assigned to one of two groups: a study group receiving remimazolam besylate and sufentanyl, and a control group receiving propofol and sufentanyl. In both groups, patients receive intravenous sufentanyl followed by the sedative drug, with doses tailored to achieve the desired sedation level assessed by BIS monitoring and the Modified Observers Assessment of Alertness and Sedation Scale (MOAA/S). Continuous oxygen flow and non-invasive monitoring are applied during the procedure. Throughout the study, patients are monitored for vital signs including oxygen saturation, heart rate, blood pressure, and respiratory rate before, during, and after the procedure. Sedation depth, time to adequate sedation, full alertness, and recovery readiness are measured. Researchers also track drug doses, procedure duration, infusion volumes, and post-procedure symptoms such as pain, nausea, and vomiting. The total observation period per participant spans approximately 2 to 4 hours.

Colorectal cancer is one of the most common and deadly cancers worldwide, with adenomatous polyps in the colon as possible precursors. Screening and removal of these polyps, especially by colonoscopy, can help prevent colorectal cancer and related deaths. This trial aims to compare two polyp removal techniques, hot snare polypectomy (HSP) and cold snare polypectomy (CSP), for polyps sized 10 to 15 mm to evaluate their complete removal rates and safety. Participants with eligible polyps will be randomly assigned to have their polyps removed either by HSP, which uses electrocautery, or CSP, which removes polyps without electrocautery. After removal, the site is thoroughly washed and examined for any remaining polyp tissue, with additional removal if needed. Four biopsies are taken from the edges of the removal site to check for leftover abnormal tissue. Throughout the study, researchers will monitor complete polyp removal rates over six months. They will also assess immediate bleeding during the procedure, difficulty of removal with CSP, time taken for removal, and any procedure-related adverse events. The study is sponsored by the Technical University of Munich and involves regular evaluations to ensure participant safety and treatment effectiveness.

Researchers are evaluating a new oral synbiotic formula called SMT04 to see if it can reduce the recurrence of advanced adenomas and related bacterial gene markers in people who have had colorectal advanced neoplasia removed. The study is a multicenter, double-blinded randomized controlled trial focused on colorectal cancer and its precancerous lesions, exploring how gut microbiome changes may influence disease progression and recurrence. The trial seeks to understand if SMT04 can sustain long-term benefits in lowering harmful bacterial markers linked to colorectal neoplasia. Participants will be randomly assigned to receive either the SMT04 synbiotic formula, which combines probiotics and heat-resistant prebiotics, or an active placebo containing a small amount of vitamin C and inert starch filler with matching appearance and flavor. The trial includes a control group receiving the placebo to compare effects. The SMT04 formula has previously been shown to increase beneficial Bifidobacterium species and reduce certain bacterial gene markers over weeks 2 to 12, but its long-term impact is still being studied. During the year-long study, participants will undergo monitoring to detect any recurrence of advanced colorectal neoplasia through colonoscopies and bacterial gene marker measurements. Researchers will track the incidence and number of recurrent adenomas and advanced neoplasia, as well as changes in bacterial gene markers and their correlation with disease recurrence. The primary outcome is the incidence of recurrent advanced colorectal neoplasia at one year. The study involves regular assessments, including colonoscopy quality checks and histopathological confirmation, to ensure thorough evaluation of treatment effects.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of HS-20110 combination therapies in patients with advanced colorectal cancer. This multicenter, open-label Phase Ib/II study uses a "Rolling 6" design for dose escalation in Phase Ib, followed by Phase II to further assess these treatments in patients with metastatic colorectal cancer (mCRC). The study includes three treatment groups receiving different HS-20110 combinations: one with Bevacizumab and 5-FU/leucovorin every two weeks, another with Bevacizumab, Oxaliplatin, and 5-FU/leucovorin every two weeks, and a third with Bevacizumab, Oxaliplatin, and Capecitabine every three weeks. The treatments are given via intravenous infusion in cycles, with doses adjusted during the study. Participants will be monitored for safety, side effects, drug levels, and response to treatment. Assessments include tumor response using RECIST v1.1 criteria, adverse events, antibody formation against HS-20110, and survival outcomes. Monitoring continues from the first dose until up to three years after the last dose. The study aims to determine the best dose and evaluate the impact on disease control and patient survival over time.

Researchers are investigating whether circulating tumor DNA (ctDNA) testing can help guide chemotherapy before surgery in patients with colorectal or appendiceal adenocarcinoma who have metastatic peritoneal disease. The study aims to determine if ctDNA levels can classify patients as low or high risk for cancer recurrence and assist doctors in deciding the intensity of chemotherapy needed before cytoreductive surgery (CRS) with or without heated intraperitoneal chemotherapy (HIPEC). Participants will have their ctDNA levels measured at the start and during neoadjuvant chemotherapy. This information will be used to tailor the duration of chemotherapy given intravenously before surgery. The study focuses on patients undergoing CRS and HIPEC with curative intent, comparing outcomes based on ctDNA status before treatment. During the trial, patients will undergo blood tests to measure ctDNA and various assessments to monitor treatment response and safety. Researchers will track recurrence-free survival, overall survival, and adverse events over about one year. Additional evaluations include tumor biology, imaging characteristics, and changes in chemotherapy regimens based on ctDNA results. Participation involves ongoing monitoring before and after surgery to understand the impact of ctDNA-guided therapy.

Researchers are evaluating the accuracy of a new artificial intelligence system called EndoAIM for measuring colorectal polyp size during real-time endoscopy. Accurate measurement of polyp size, especially at the 10 mm threshold, is important for assessing the risk of advanced neoplasia and colorectal cancer, as well as deciding the best removal method. Current visual estimates by doctors can be inaccurate, leading to risks of delayed diagnosis or unnecessary procedures. In this study, EndoAIM will be used during the withdrawal phase of colonoscopy procedures to automatically estimate polyp diameters. This device aims to improve measurement accuracy compared to visual estimates or non-calibrated tools. The study focuses on real patients undergoing colonoscopy, assessing EndoAIM’s performance in real-time clinical settings. Participants will undergo colonoscopy with EndoAIM used to measure polyps during the procedure. Researchers will compare measurement accuracy at 10 mm and 5 mm thresholds and evaluate the correctness of size estimations. The primary outcome is the difference in percentage accuracy at the 10 mm threshold during colonoscopy. Secondary outcomes include accuracy at the 5 mm threshold and the proportion of polyps and subjects measured correctly. The study includes adults aged 18 and older and involves monitoring during the colonoscopy procedure.