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Intestinal Neoplasms clinical trials

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NCT ID: NCT06256705 Recruiting - Radiotherapy Clinical Trials

Multi-modal Characterisation of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort

OPERANDI-NET
Start date: March 25, 2024
Phase: N/A
Study type: Interventional

Operandi project aims to address unmet clinical needs in the current management of GEP-NETs treated with PRRT by exploring new opportunities provided by imaging-based artificial intelligence (AI) and data augmentation, simultaneous PET-MRI imaging, and novel approaches to increase patient selection and PRRT efficacy (genomic profiling, radiopotentiators, and new radionuclides). The study aim to identify predictive and early markers indicative of PRRT effectiveness based on a large prospective cohort of GEP-NET patients. This cohort will be used to uncover relevant predictive signatures within the morphological, functional, and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous PET-MRI. Considering this global objective, the objective of this clinical research protocol is to provide clinical, molecular and imaging data in a prospective standardized study, notably by performing systematic PET-MRI at baseline, at middle course of PRRT and at 1 year of the beginning of PRRT, in patients with advanced GEP-NETs treated with PRRT.

NCT ID: NCT06228209 Recruiting - Clinical trials for Advanced Lung Cancer

Tier - Palliative Care For Patients With Advanced Heart Failure or Cancer

TIER-PC
Start date: January 26, 2024
Phase: N/A
Study type: Interventional

TIER-PC is an adaptive model of delivering palliative care that provides the right level of care to the right patients at the right time. It represents an adaption of the Mount Sinai PALLIATIVE CARE AT HOME (PC@H) program, which delivers home-based palliative care. TIER-PC increases the number and intensity of disciplines added to the patient's care team as their symptoms worsen and function declines. In Tier 1, patients who are able to care for themselves and no/mild symptoms receive a community health worker (CHW) trained to elicit illness understanding in a culturally competent way. In Tier 2, for patients with poorer function and mild symptoms, a social worker (SW), trained in serious illness communication, joins the CHW to further elicit patients' goals and prognostic understanding while communicating symptom needs to their primary clinician. In Tier 3, as function decreases and symptoms increase, an advance practice nurse (APN) joins the CHW and SW to manage complex symptoms. Finally, in Tier 4, for those older adults with the poorest function and most complex symptoms, a physician joins the team to ensure that the most complex needs (e.g., end-of-life treatment preferences and multifaceted symptom control) are met. The CHW follows patients longitudinally across all tiers and re-allocates them to the appropriate tier based on their evolving needs.

NCT ID: NCT06155318 Recruiting - Clinical trials for Gastroenteropancreatic Neuroendocrine Tumor

68Ga-DOTATOC PET for the Evaluation of Gastroenteropancreatic Neuroendocrine Tumours

Start date: September 5, 2019
Phase:
Study type: Observational

Gastroenteropancreatic neuroendocrine tumours (GEP-NETs) are a heterogeneous group of neoplasms that arise from the endocrine cells of the gastroenteropancreatic tract. The diagnostic work-up of these tumours include Computed Tomography (CT), Endoscopic Ultrasound (EUS), Magnetic Resonance Imaging (MRI). The majority of these tumours express somatostatin receptors on their surface. For this reason, in addition to traditional imaging exams, diagnostic work-up of GEP-NETs should include a Positron Emission Tomography/CT with 68Ga labeled somatostatin analogues targeting somatostatin receptors with high sensitivity and specificity. 68Ga-DOTATOC PET/CT scan is a corner stone to assess GEP- NET patients at different stage of disease and it is the standard functional imaging modality to study well-differentiated Pan-NETs, as reported in the being also included in the guidelines of the European Association of Nuclear Medicine (EANM). Moreover, quantitative parameters extracted from 68Ga- DOTA-peptides PET imaging have demonstrated their prognostic utility as markers for progression-free survival and disease specific mortality in patients affected by NET. Additionally, 18F-FDG PET can be used for evaluating the possible presence ofa high-grade component within the tumour itself. The accurate morphofunctional characterization is of utmost importance in the field of GEP-NET. the advent of new hybrid scanners, namely PET/MRI, opens the way to an innovative diagnostic work- up that can be applied to GEP-NETs. In fact, MRI plays a role as morphological imaging modalities for a better characterization of soft-tissue and liver parenchyma compared to CT; moreover, the low radiation exposure related to MRI, makes this imaging modality more suitable for patients requiring several imaging during follow-up. Patients requiring 68Ga-DOTA peptides (68Ga-DOTATOC) PET scan and eventually MRI scan, can be studied in a single session examination, by using 68Ga-DOTATOC PET/MRI. Considering the rarity of GEP_NETs, it is quite difficult to collect a sufficient number of patients in order to investigate the accuracy, predictive and prognostic value of the currently available imaging technique in this scenario. Based on these considerations, the possibility to analyze PET images deriving from both PET/CT and PET/MRI scans of patients affected by GEP-NET is of fundamental relevance in order to provide answers to the currently unmet clinical needs.

NCT ID: NCT06016855 Recruiting - Clinical trials for Metastatic Malignant Neoplasm in the Liver

Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors

Start date: April 30, 2024
Phase: Phase 4
Study type: Interventional

This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor (SSTR) positive, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread from where they first started (primary site) to the liver (hepatic metastasis). Lutetium Lu 177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells. Lutetium Lu 177 dotatate includes a radioactive form (an isotope) of the element called lutetium. This radioactive isotope (Lu-177) is attached to a molecule called dotatate. On the surface of GEP-NET tumor cells, a receptor called a somatostatin receptor binds to dotatate. When this binding occurs, the lutetium Lu 177 dotatate drug then enters somatostatin receptor-positive tumor cells, and radiation emitted by Lu-177 helps kill the cells. Giving lutetium Lu 177 dotatate after surgical debulking may better treat patients with grade 1/2 GEP-NETs

NCT ID: NCT05997056 Recruiting - Clinical trials for Neuroendocrine Tumors

Trial of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the Gastrointestinal Tract, Lung, or Pancreas Who Have Not Received Prior Treatment With mTOR Inhibitors

Start date: November 7, 2023
Phase: Phase 2
Study type: Interventional

A Phase 2 multi-center, open-label, single arm study of nab-sirolimus in patients with well-differentiated neuroendocrine tumors (NETs) of the gastrointestinal tract, lung, or pancreas who have not received prior treatment with mTOR inhibitors

NCT ID: NCT05899985 Recruiting - Gastric Cancer Clinical Trials

Magnetic Sentinel Lymph Node Mapping in Upper Gastro-Intestinal Cancer: A Feasibility Clinical Investigation

MAGMAP
Start date: March 21, 2024
Phase: N/A
Study type: Interventional

This is a multi-centre, partially blinded, side-by-side comparator study to assess the safety and tolerability, feasibility, and potential added diagnostic and clinical value of using the FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) System for mapping sentinel lymph nodes (SLNs) in subjects with gastric, gastric-oesophageal junction, and oesophageal cancers, consisting of a safety lead-in phase and an expansion phase.

NCT ID: NCT05853094 Recruiting - Colorectal Cancer Clinical Trials

Postoperative Effects of Different Enterostomy Approaches

Start date: June 23, 2023
Phase: N/A
Study type: Interventional

Exploring the effect of protective ileostomy compared with transverse colostomy on the occurrence of complications, the occurrence of serious side effects of adjuvant chemotherapy and disease recurrence in patients with low rectal cancer after radical surgery from the perspective of intestinal microecology.

NCT ID: NCT05850884 Recruiting - Clinical trials for Intestinal Parasites in Patients With Intestinal Cancer

Evaluation of Intestinal Parasites in Patients With Intestinal Cancer in Sohag, Egypt.

Start date: November 30, 2023
Phase:
Study type: Observational [Patient Registry]

This study aims to evaluate the intestinal parasitic infections in patients with intestinal cancer in comparison to non-cancer individuals

NCT ID: NCT05652348 Recruiting - Gastric Cancer Clinical Trials

Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer

Hi-STEP1
Start date: December 8, 2022
Phase:
Study type: Observational

Patients with gastric or colon cancer with peritoneal carcinomatosis will receive a biopsy of the tumor during their primary curative surgery. The operation is performed according to standard and includes resection of the primary tumor and any metastases and followed by HIPEC (Intraperitoneal hyperthermic chemoperfusion) according to the respective hospital standard. Organoid cultures from the biopsies are established in the research laboratory. Various chemotherapeutic agents are tested on these tumor organoids in the laboratory and the tumor organoids are analyzed in detail with regard to genetic alterations in order to find alterations that can be addressed, if necessary, by means of targeted drugs against peritoneal carcinomatosis.

NCT ID: NCT05517408 Recruiting - Gastric Cancer Clinical Trials

Dose Exploration of Ciprofol for Sedation in Gastrointestinal Endoscopic Diagnosis and Treatment of Obese Patients.

Start date: September 19, 2022
Phase: N/A
Study type: Interventional

Ciprofol is a new anesthetic, which combines with γ- Aminobutyric acid-a (GABAA) receptor. Ciprofol has shown equivalent anesthetic efficacy of propofol at 1/4 to 1/5 of the dosage. Ciprofol has the pharmacodynamic characteristics of rapid onset, stable and rapid recovery. Phase III clinical results showed that the incidence of injection pain and respiratory and circulatory depression of ciprofol was lower than that of propofol. Therefore, ciprofol has a good application prospect in sedation for gastrointestinal endoscopy, especially for obese patients. In the current study, we would explore the proper dose of Ciprofol in sedated gastrointestinal endoscopy in obese patients.