Adenomatous Polyposis

Researchers are evaluating the potential usefulness of 18F-FAPI-04 positron emission tomographycomputed tomography PETCT and positron emission tomographymagnetic resonance imaging PETMR 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 PETCT and PETMR 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 berberines 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 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 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 MOAAS. 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 studying BLU-924 SAR449336, a pan-KRAS inhibitor, in people with advanced pancreatic ductal adenocarcinoma, non-small cell lung cancer, or colorectal cancer that have specific KRAS mutations. This open-label Phase 12 trial aims to evaluate the safety, tolerability, how the drug moves through the body, and its antitumor effects in these participants. The study focuses on metastatic cancers with KRAS mutations and includes multiple stages to determine appropriate dosing and preliminary efficacy. Participants will receive BLU-924 as an oral tablet once daily during Dose Escalation, Dose Enrichment, and Dose Expansion phases. Dose Escalation and Enrichment are used to find the maximum tolerated dose and recommended dose for expansion, with dose levels adjusted based on safety and tolerability. Dose Expansion further studies safety and antitumor activity at the recommended dose in specific cancer types harboring KRAS mutations. There is no active combination treatment arm at this time. Throughout the study, participants undergo safety monitoring, evaluation of side effects, and pharmacokinetic assessments. Researchers will measure dose-limiting toxicities, adverse events, response rates, duration of response, disease control, progression-free survival, and overall survival over a follow-up period of up to five years. Blood tests, tumor imaging, and other clinical assessments will be conducted regularly to observe treatment impact and drug behavior in the body.

Colorectal cancer can often be prevented by removing pre-malignant polyps during colonoscopy. Large non-pedunculated colorectal polyps LNPCPs measuring 20mm or more need careful evaluation because the presence of submucosal invasive cancer SMI determines if endoscopic treatment alone is enough or if surgery is required. Existing classification methods for detecting SMI are complex and underused in many hospitals, so a simpler approach is needed. A new web-based clinical decision support tool has been developed using common endoscopic features like demarcated areas, polyp size, Paris classification, location, and granularity to help identify SMI in LNPCPs. This tool uses standard imaging available in most endoscopy units. The study is a prospective multicenter trial across several countries, where endoscopists of varying experience assess sets of 10 large polyps using the tool before and after randomized educational interventions, including a short instructional video or a longer interactive session. A follow-up assessment at 3 months checks how well the learning is retained. Participants include endoscopists who assess live colonoscopies with the tool and create standardized videos of lesions for expert comparison. Various accuracy and agreement measures are recorded throughout the study, alongside histology results of resected polyps. The study tracks performance before training, immediately after, and three months later, lasting up to 48 months. Safety and data quality are monitored continuously, and expert opinion serves as the reference standard for assessment accuracy.

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 a personalized surveillance and intervention protocol for duodenal and gastric polyposis in patients with familial adenomatous polyposis FAP. FAP patients are at high risk for developing duodenal adenomas, which can lead to duodenal cancer in a small percentage of cases. The study aims to improve prevention of advanced neoplasia by removing lesions early, addressing concerns about current classification and treatment methods that may not adequately predict or prevent cancer. This study involves one group where participants receive endoscopic surveillance and interventions according to a personalized schedule. The intervals between endoscopies range from 3-6 months up to 5 years, depending on the severity of polyposis and previous treatments. The protocol focuses on monitoring and removing lesions to prevent cancer development and avoid the need for risky surgery. Participants will undergo regular endoscopic examinations and interventions as needed, with follow-up evaluations extending up to five years. Researchers will monitor the occurrence of advanced neoplasia, recurrence rates after different endoscopic treatments, intervention feasibility, diagnostic accuracy, complication rates, surveillance burden, and any surgeries performed. These assessments aim to provide comprehensive safety and effectiveness data for the personalized protocol.