Familial Adenomatous Polyposis

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 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.

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 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.

Researchers are evaluating a personalized surveillance and intervention protocol for patients with familial adenomatous polyposis (FAP) who have undergone prophylactic (procto)colectomy. FAP causes numerous polyps in the colon and rectum, leading to nearly certain colorectal cancer if untreated. Surgery such as restorative proctocolectomy or subtotal colectomy is performed to reduce cancer risk, but lifelong monitoring is needed due to the risk of new adenomas developing in remaining tissues. This study aims to provide evidence for tailored endoscopic surveillance intervals to prevent advanced neoplasia by removing lesions early. Participants will follow a personalized endoscopic surveillance schedule with intervals ranging from 6 months to 2 years, based on the severity of their polyposis and endoscopic interventions performed. They will undergo regular endoscopic examinations to monitor and remove polyps larger than 5mm as recommended by guidelines. This one-arm observational study focuses on how personalized timing of surveillance affects outcomes after (procto)colectomy with IRA/ISA or IPAA. During the study, participants will have endoscopic assessments to track the development of advanced neoplasia and characteristics of polyps. Researchers will evaluate the effectiveness and feasibility of different endoscopic removal techniques, the need for additional surgery, surveillance burden, and any complications over up to five years. This long-term monitoring aims to improve personalized care and optimize surveillance strategies for FAP patients post-surgery.

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 safety and early signs of effectiveness of a drug called [177Lu]Lu-OncoFAP-23 alone or combined with another drug, L19-IL2, for treating advanced or metastatic solid tumors that test positive for Fibroblast Activation Protein (FAP). This phase I study aims to find the appropriate dose and understand how these treatments may work in patients who have limited treatment options. The study includes two parts: first, a dose escalation phase where small groups of patients receive increasing doses of [177Lu]Lu-OncoFAP-23 to identify the maximum tolerated dose and recommended dose. In the second part, more patients receive either the recommended dose of [177Lu]Lu-OncoFAP-23 alone or combined with L19-IL2. Treatments are given in up to four cycles spaced about eight weeks apart. Participants will undergo regular assessments including imaging scans, blood tests, and monitoring for side effects during and after treatment for up to one year. Researchers will track dose limiting toxicities, liver injury, and other adverse events while also looking for early signs that the treatment might be effective. Patients will have scheduled visits to follow the treatment plan and undergo laboratory tests to evaluate safety and response.

This observational study aims to understand how force feedback instruments are useful during surgeries performed with the da Vinci 5 robotic system. It focuses on procedures such as inguinal and ventral hernia repairs, colorectal, thoracic, gynecologic surgeries, and partial nephrectomy. The study is designed to gather information on how these instruments perform during robotic-assisted surgery. Participants will undergo multi-port robotic-assisted surgery using the da Vinci 5 system equipped with force feedback instruments, which provide tactile sensations. The study observes surgeries planned as primary procedures with these instruments, without altering the treatment. There is no experimental drug or placebo involved, as this is an observational study conducted after the devices have been marketed. During the study, researchers will measure the force applied to tissues by the force feedback instruments during surgery and evaluate how useful these instruments are during specific steps of the procedure before patient discharge. Participants will be followed up as per the study protocol to ensure data quality. The total participation time varies depending on the surgical procedure and follow-up schedule.

Researchers are comparing two bowel cleansing agents, Plenvu and Picoprep, used before colonoscopy to check for colon disease, mainly to exclude cancer. This phase 4 trial investigates whether the newer, low-volume Plenvu is at least as effective as the established Picoprep in cleaning the bowel, while also examining patient tolerability and compliance. The study is conducted at a single center in North Jutland with 400 patients referred for colonoscopy. Participants are randomly assigned to receive either Picoprep or Plenvu. Picoprep involves taking two doses dissolved in water before the procedure, with fluid intake totaling approximately 2.3 liters. Plenvu is taken in a two-day regimen with two separate doses dissolved in 500 ml water each, accompanied by additional fluids for a total of 2 liters. Both agents require dietary restrictions before colonoscopy, including avoiding seed-containing foods five days prior and following a fluid diet the day before. During the study, participants complete a questionnaire about side effects and their experience with the bowel preparation before the colonoscopy. The colonoscopist, who does not know which agent was used, assesses bowel cleansing quality using the Harefield Cleansing Scale. Data on efficacy and tolerability are collected and analyzed. Participants are followed for about 30 hours after the last dose. The trial will end once 400 patients have completed participation.