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NCT ID: NCT06327386 Recruiting - Cancer Clinical Trials

The Therapeutic Efficacy of 18F-FDG Combined With 18F-FAPI PET/MR in Neoadjuvant Therapy for Gastric Cancer

Start date: January 1, 2024
Phase:
Study type: Observational

Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related deaths. Although surgical treatment can benefit the survival of the vast majority of patients, currently only early gastric cancer patients can be cured directly through endoscopic resection or surgery alone. Neoadjuvant therapy reduces tumor volume and improves tumor response rate through preoperative radiotherapy and chemotherapy, thereby increasing R0 resection rate and improving overall survival, without increasing postoperative complications and mortality. Timely imaging re staging during neoadjuvant therapy can allow patients to enter the surgical stage earlier, thereby reducing their preoperative burden. According to the different stages of neoadjuvant therapy, clinical staging can be divided into baseline stage (cBSstage) and clinical rest stage (cReStage) after neoadjuvant therapy. At present, the conventional imaging methods for diagnosing cBStage in gastric cancer include CT, endoscopic ultrasonography (EUS), and MRI. The NCCN guidelines recommend CT for cBStage, with a diagnostic accuracy of 77.1% to 88.9%. Similarly, EUS and MRI were also used for cBStage, with accuracy rates of 65.0% to 92.1% and 71.4% to 82.6%, respectively. The application of diffusion-weighted imaging (DWI) has improved the accuracy of MRI diagnosis of cBStage to 93%. However, due to the destruction of the gastric wall structure by neoadjuvant therapy, accurate imaging re staging is difficult. Currently, accurate tumor regression grading can only be obtained through surgical resection of pathological specimens. For cReT after neoadjuvant therapy, the diagnostic accuracy of EUS is only 63% (T2: 44%, T3: 68%, T4: 90%). Due to the presence of chronic inflammatory reactions, such as tumor cell apoptosis, necrosis, fibrosis, etc., in both the tumor and the critical normal gastric wall after neoadjuvant therapy, imaging cannot accurately identify the level of gastric wall, leading to the current low value of CT for cReT. Meanwhile, due to the fact that the pathological reactions of lymph nodes after neoadjuvant therapy are mainly subacute inflammatory reactions accompanied by scar tissue formation, and not all lymph node volumes that experience these pathological reactions will rapidly decrease, the accuracy of CT diagnosis of cReN is only 44%, while the sensitivity and specificity of EUS diagnosis of cReN are 50% and 56%, respectively. In addition, positron emission tomography (PET) can reflect the abnormal metabolism, protein synthesis, DNA repair, and cell proliferation of tumors at the molecular level, providing important information in tumor grading diagnosis, prognosis evaluation, treatment decision-making, and efficacy monitoring. The conventional positron tracer 18F-FDG can reflect the glucose metabolism ability of different tissues, while most types of malignant tumors exhibit high metabolism. Therefore, 18F-FDG can be used for the diagnosis, staging, and treatment monitoring of cancer. However, in gastric cancer patients, 18F-FDG has certain limitations, including 1) interference with physiological or inflammatory uptake of the gastric wall; 2) Low uptake of 18F-FDG is present in signet ring cell carcinoma, mucinous adenocarcinoma, or other poorly differentiated cancers with high mucus content; 3) There are cases of false positive FDG after immunotherapy. In the study of SUV changes in the tumor area before and after treatment, it was found that patients with postoperative pathological regression grades 1-5 Δ SUVs are between 0-70%. Tumor associated fibroblasts are closely related to tumor growth, invasion, and distant metastasis, and their activation requires the involvement of fibroblast activation protein (FAP). Therefore, radiolabeled fibroblast activation protein inhibitor (FAPI) can achieve in vivo FAP targeted tracing and quantification by specifically binding to FAP. Currently, a large number of studies have shown that 18F-FAPI is superior to 18F-FDG in the staging and re staging of gastric cancer. Furthermore, prospective studies have shown a certain relationship between tumor regression grade (TRG) and 18F-FAPI rate of change parameters (SUVmax, SUVavg, SUVR). Therefore, in the early stage of this study, 18F-FAPI combined with 18F-FDG PET/MRI imaging was used to evaluate the efficacy of neoadjuvant therapy for gastric cancer, preoperative assessment of tumor regression grade after treatment, and re staging to guide the development of further clinical treatment plans.

NCT ID: NCT06326567 Recruiting - Cancer Clinical Trials

Comprehensive Connected Cancer Care (C4): Intervention Evaluation

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

The C4 program aims to provide a multi-level intervention program (Patient Level, Healthcare Team and Healthcare System Level) that improves the coordination of care with supportive/ancillary care providers and community services through the use of patient navigation and a digital needs assessment and a closed-loop referral system and improves patient-centered communication and engagement in care through skills training for the healthcare team and provision of culturally appropriate patient educational tools and resources. The program components incorporate three areas that are critical to improving patient-centered care: coordination of care, patient-centered communication and engagement, and psychosocial care and other supportive services.

NCT ID: NCT06318338 Recruiting - Cancer Clinical Trials

Virtual Reality to Promote Relaxation Prior to Simulation

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

The purpose of this study is to assess the feasibility of a pre-simulation virtual reality (VR) platform designed to promote relaxation for cancer patients planned for radiation therapy (RT).

NCT ID: NCT06317961 Recruiting - Cancer Clinical Trials

Pilot Study on the Use of iENTER, iCONSENT and iPARTICIPATE E-tools

Start date: April 5, 2023
Phase:
Study type: Observational

Precision oncology is the future of fighting cancer. Cancer Core Europe (CCE) developed a precision medicine trial, i.e. the Basket of Basket (BoB) study, to provide personalised treatment to a large number of patients by incorporating a molecular profiling platform. The EU-funded CCE_DART project, developed within the CCE Consortium, is aimed at improving efficiency and transform platform trials into data-rich translational research programmes. Within the CCE_DART project working area D "Patient involvement through information and partnership" three interconnected web e-tools were developed aimed at promoting patient information, recruitment, and involvement as well as facilitating adherence to the CCE BoB trial: 1) iENTER: informative web site addressed to potential BoB trial participants, their caregivers, patients' advocates, and the public; 2) iCONSENT: web app for remote management of the informed consent process in the CCE BoB trial.3) iPARTICIPATE: web app allowing remote access to BoB trial patients trial visits calendar, medications list and posology, to upload documents and download reports, messaging between patients and clinical staff. The main objective of this study is to carry out field testing and assess usability of the e-tools iENTER, iCONSENT and iPARTICIPATE. The study is also addressed at collecting patients' suggestions for improvements of the e-tools.

NCT ID: NCT06307249 Recruiting - Breast Cancer Clinical Trials

Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA

PTST_PALBEVA
Start date: February 15, 2023
Phase: Phase 1
Study type: Interventional

Solid tumors pose significant challenges in current therapeutic approaches. Targeted therapy has emerged as a promising avenue, aiming to enhance treatment efficacy while minimizing adverse effects. This clinical trial focuses on an innovative combination of two targeted inhibitors, Palbociclib and Bevacizumab, for their potential synergistic effects in addressing these challenging malignancies. Moreover, this study incorporates a molecular approach by considering Long Non-Coding RNAs (LncRNAs) as biomarkers. Initiating with a focus on colorectal cancer, the study aims to expand its scope to other solid tumors, including lung, breast, ovarian and other cancers. Palbociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, disrupts the cell cycle progression, particularly in cancer cells with specific molecular characteristics. Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, targets angiogenesis-a critical process for tumor growth and metastasis. The rationale behind combining these agents lies in their complementary mechanisms of action, potentially leading to enhanced antitumor effects. LncRNAs have shown promise in predicting treatment response and prognosis in various cancers, providing an additional layer of precision to the treatment strategy. By elucidating the molecular basis through LncRNA analysis, the trial aims to tailor the treatment to the specific molecular profile of each patient, ultimately striving for better outcomes and improved survival rates. This novel combination therapy, coupled with a personalized biomarker-driven approach, represents a cutting-edge strategy in the pursuit of more effective and individualized treatment for solid tumors.

NCT ID: NCT06304155 Recruiting - Cancer Clinical Trials

Application of FDG Combined With FAPI PET Dual Imaging in the Diagnosis and Staging of Oropharyngeal and Laryngeal Cancer

Start date: January 1, 2024
Phase:
Study type: Observational

According to statistics, in 2020, new head and neck malignancies in the world accounted for 4.9% (931931 cases) of malignant tumors in the whole body, and the new death cases were 467125, accounting for 4.7% of malignant tumors in the whole body. The high incidence rate and mortality brought great burden to the medical system. In addition, due to various types of head and neck cancer, hidden location, impact on function and quality of life, and low overall survival rate, this type of disease has seriously threatened human health and social development. The incidence of oropharyngeal cancer and laryngeal cancer is more subtle. Traditional examination methods include CT(computer tomography), MR(magnetic resonance), and laryngoscopy, but they cannot make accurate judgments on the systemic TNM(primary tumor, regional nodes, metastasis) staging of oropharyngeal cancer and laryngeal cancer. 18F-FDG(18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) PET/CT examination can better diagnose and stage compared to traditional examination methods. However, due to the interference of more inflammatory lesions or physiological uptake in the pharynx, the false positive rate of 18F-FDG PET/CT examination is significantly increased, 18F-FAPI(18F-fibroblast activation protein inhibitors) is a novel broad-spectrum tumor imaging agent that can be specifically uptake by fibroblasts in the tumor microenvironment, and has lower physiological uptake and acute inflammatory lesion uptake in the larynx. 18F-FAPI PET/CT examination can more accurately stage tumors throughout the body than 18F-FDG PET/CT examination. Combined with PET/MR local scanning, it will further improve the accuracy of T and N staging of local tumors. Therefore, It is of great significance for clinical diagnosis and treatment to effectively and reliably determine the systemic TNM staging of oropharyngeal and laryngeal cancer through non-invasive methods.

NCT ID: NCT06299800 Recruiting - Cancer Clinical Trials

Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer

TCPT2023
Start date: February 4, 2024
Phase:
Study type: Observational

Recent research has highlighted the significant relationship between type 2 diabetes mellitus and cancer, both prevalent and impactful on global health. The intrinsic correlation arises from shared metabolic processes, particularly a systemic and chronic inflammatory state driven by factors like obesity, dyslipidemia, and hyperglycemia. This leads to the creation of a self-sustaining microenvironment known as meta-inflammation, promoting cancer development through DNA damage, oxidative stress, and the influence of hormones like leptin. The hyperglycemic environment in diabetes contributes to cancer development, supporting the Warburg effect and insulin-related mechanisms. This study aims to identify risk factors associated with diabetes that impact tumor development and progression, crucial for guiding effective preventive strategies in clinical practice. Primary objective of the study: - identify the risk factors affecting the occurrence of cancer in the population affected by type 2 diabetes mellitus; Secondary objectives of the study: - description of the demographic, clinical and first-line therapy characteristics of patients diagnosed with type 2 diabetes mellitus; - assess risk factors for recurrence, presence of a second tumour not related to the first and the presence of both events in patients who have had a tumor within 10 years of diagnosis of diabetes; - assess the relationship between the characteristics of patients and the time to the onset of cancer.

NCT ID: NCT06299722 Recruiting - Cancer Clinical Trials

Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents

STEEL
Start date: March 15, 2024
Phase: N/A
Study type: Interventional

We aim to include 60 children and adolescents aged 10 to 19 years who have undergone successful treatment for leukemia or lymphoma. Based on randomization, they will either 1) commence 16 weeks of training with STEEL or 2) commence 16 weeks of circuit training. STEEL training involves exercises for major muscle groups using free weights, body weight, or tailored machines. Circuit training is structured similarly to previous training for the target group and includes exercises using body weight, exercise balls, and rings. The training takes place in local centers either with friends or with other participants in the project. Before starting participation in the project, the child/adolescent and their parents or guardians will receive information about late effects, diet, sleep, and exercise, providing guidance and support regarding the project elements. The effects of the two training modalities will be evaluated based on self-reported quality of life, muscle strength, muscle mass, bone mineral content, fitness, and markers of metabolic syndrome (BMI, waist circumference, blood pressure, and blood analysis).

NCT ID: NCT06291688 Recruiting - Cancer Clinical Trials

Applying Mobile Healthcare Education to Improve Cutaneous Self-care Capability

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

The goal of this clinical interventional study is to compare the efficacy of mobile healthcare education in two ways (game-based or text-based) to improve cutaneous self-care capability in cancer patients receiving EGFR-based target therapy. The main questions it aims to answer are: Impact of different mobile healthcare education ways on cutaneous self-care capability of patients Impact of different mobile healthcare education ways on learning motivation of patients towards cutaneous self-care knowledge and skills Participants will be randomly divided into two groups. Both groups will download a healthcare education application on their phone. One group will accept the education about the knowledge and self-care skills of cutaneous adverse drug reaction by playing game. In contrast, the other group will accept the same education content by reading text on the phone. Subjects will be asked to use the application at home for two weeks after giving consent to participate this study, and then completed questionnaire three times during study period. The timepoints of completing questionnaire are listed following: Baseline / pre-intervention test (after signing informed consent form, D1) First post-intervention test (after finishing intervention, D15) Second post-intervention test (D30) Researchers will compare game group and text group to see if game group has better performance on cutaneous self-care capability and learning motivation.

NCT ID: NCT06284070 Recruiting - Cancer Clinical Trials

Application of FAPI and FDG PET Imaging in Patients With Different Types of Cancer

Start date: January 1, 2024
Phase:
Study type: Observational

Cancer associated fibroblasts (CAFs) can promote tumor cell proliferation, migration, invasion, and angiogenesis through immunosuppressive effects and the production of mediators, thereby promoting tumor growth and progression. The characteristic of CAFs is high expression of fibroblast activation protein (FAP). In approximately 90% of epithelial derived tumors, FAP is highly overexpressed on the membrane of CAFs. Contrary to CAFs, FAP expression is lower or absent in normal tissues. Therefore, FAP inhibitors (FAPI) targeting FAP can overcome the limitations of 18F-2-fluoro.2-deoxy-D-glucose fluorodeoxyglucose(18F-FDG) PET imaging. But like 18F-FDG, wound healing, fibrosis, and inflammation can also uptake FAPI.. Therefore, a comparison of the performance of 18F-FDG and 18F-FAPI PET imaging in diagnosing primary and metastatic lesions of various types of cancer is conducted to evaluate the potential value of these new radiopharmaceuticals as effective alternatives to 18F-FDG, highlighting their advantages and limitations.