Clinical Research Directory

Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors

The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to \<18 years of age with somatostatin receptor (SSTR)-positive tumors.

Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions

The goal of this observational study is to evaluate the long-term clinical effectiveness of EUS-RFA and quality of life in patients with pancreatic or adrenal tumors recieving EUS-RFA. Primary Objectives: * Clinical effectiveness: To evaluate the proportion of included patients who show doc-umented improvement in their clinical symptoms and biochemical parameters (blood test results) over time. * Patient satisfaction: To assess patient satisfaction with the procedure and subsequent disease-related quality of life, measured using validated questionnaires. Secondary Objectives: * Safety: To determine the proportion of treated patients who experience complications, as defined by the AGREE classification, within 30 days after the procedure. * Technical success: To assess the proportion of included patients in whom the EUS-RFA procedure can be successfully completed. Exploratory Objectives: • To identify factors associated with adverse events and factors related to clinical success or lack there of. The study is observational. All participant will receive EUS-RFA as part of their standard clinical care. Participants will: * Undergo EUS-RFA, in which a fine needle is guided into the tumor using an endo-scope and ultrasound imaging. Radiofrequency energy is applied through the needle to heat and destroy tumor cells while protecting the surrounding tissue. * Have follow-up visits including blood tests, imaging scans, and clinical evaluations at regular intervals for up to 5 years after treatment. * Complete validated questionnaires about satisfaction and quality of life. The study will include approximately 138 patients recruited between 2025 and 2035 from two Danish hospital departments (Herlev and Gentofte Hospital and Rigshospitalet). Data collection will continue until 2040 to assess long-term outcomes. This study may help determine whether EUS-RFA can serve as a safe and effective alternative to traditional surgery for selected patients with small hormone-producing or benign tumors in the pancreas or adrenal glands, potentially reducing surgical risks and improving recovery and quality of life.

Effect of OFA, OSA Versus Opioid-based Anesthesia on NETs and Cancer Cell Malignancy After Colorectal Cancer Surgery

Adult patients aged 18-80 years old, American Society of Anesthesiologists physical status I-III, who were scheduled for elective colorectal cancer surgery under general anesthesia were recruited for this study. They were randomized to receive opioid-free anesthesia (OFA), opioid-sparing anesthesia (OSA) and opioid-based anesthesia (OA) group. Blood samples were collected pre-surgery and 24h post-surgery. As primary endpoint, serum neutrophil myeloperoxidase (MPO) and citrullinated histone3 (CitH3) was measured. The secondary endpoints included the effects of postoperative serum on colorectal cancer (CRC) cells malignancy, numerical rating scale (NRS) scores, postoperative adverse events and recovery profiles. For OA group, intraoperative remifentanil and sufentanil were used and postoperative patient controlled intravenous analgesia (PCIA) was performed with 0.5μg/ml of sufentanil and 0.75 mg/mL flurbiprofen, and the PCIA was stopped 48 h after surgery. For OSA group, remifentanil and sufentanil were used only for anesthetic induction and the patient received ultrasound-guided transversus abdominis plane (TAP) nerve blockwas performed. Patient controlled intravenous analgesia (PCIA) was performed with 1mg/mL of oxycodone and 0.75 mg/mL flurbiprofen after surgery, and the PCIA was stopped 48 hours after surgery. For OFA group, intraoperative epidural anesthesia combined with general anesthesia was used, and esketamine, lidocaine and dexmedetomidine for analgesia. Patient controlled epidural analgesia (PCEA) was used and terminated 48 hours after surgery.

Evaluate the Diagnostic Efficacy, Pharmacokinetics and Safety of 68Ga-DOTATATE Injection PET/CT in NETs

Evaluate the diagnostic efficacy, pharmacokinetics and safety of 68Ga-DOTATATE injection PET/CT in NETs

A Dual-targeting Tracer TATE-RGD for the Diagnosis of SSTR- and RGD- Positive Tumors

The US FDA approved a targeted somatostatin receptor 2 imaging agent, 68Ga-DOTATATE, in 2016. It has higher uptake in small cell lung cancer, pulmonary carcinoid, and medullary thyroid cancer. Integrin αvβ3 is highly expressed in some tumor cells and new blood vessels, making it an ideal target for targeted diagnosis and treatment of tumors and tumor vessels.68Ga-labeled DOTA-TATE-RGD is a new type of tumor-specific imaging agent developed by researchers based on the above foundation, which is used for targeted diagnosis and internal radiation therapy for patients with SSTR2 and αvβ3 positive tumors.