First-in-human Navigation Endoscopic Ultrasound (EUS) System Clinical Study

The implementation of Echo-endoscopy (or EUS for: Endoscopic UltraSound) is limited by the difficulty of obtaining quality EUS procedures, since the accuracy of the method relies on the endoscopist's abilities. Indeed, both cognitive and technical skills are required for endoscopic manipulation and image interpretation, as well as a thorough knowledge of intra-abdominal anatomy. The &#x0022EUS-GPS&#x0022 system aims to assist the operator in understanding the orientation and location of the probe tip within the patient. For that, a Global Positioning System (GPS) for EUS procedures is intraoperatively provided, using a 3D-based model based on recorded preoperative data.

In this clinical investigation, the EUS GPS system is intended to help EUS operators to correctly navigate towards the pancreatic gland, perform a comprehensive assessment of the area of interest, and aid in the detection and identification of lesions.

Survival Analysis After Neoadjuvant Therapy in Patients With Resectable Pancreatic Cancer and Risk Factors

Resectable Pancreatic Cancer represents an important health problem not because of its incidence, but because of its high mortality. Diagnosis in the initial stages is difficult, since the first symptoms of disease are often nonspecific. Only 15 – 25% of patients would undergo surgery with curative resection at the time of initial diagnosis. There is no an effective screening test for early diagnosis. A characteristic that defines the pancreatic adenocarcinoma is its aggressiveness. There is a high prevalence of patients who present metastatic disease at the time of diagnosis, therefore, it is evident that this tumor is capable of early systemic spread. Starting from the high prevalence of patients who experience metastatic disease shortly after undergoing a potentially curative resection, it is likely that at the time of diagnosis, the majority of pancreatic adenocarcinomas have progressed to systemic spread. The overall 5-year survival of the patients is 5.8% and has not increased in the last 10 years; the 5-year survival rate after curative surgery is not higher (7%). Patients with resectable adenocarcinoma of the pancreas, only 15% are diagnosed at an early stage (T1, T2 without lymph node involvement), these are associated with improved survival. The surgery required to treat pancreatic cancer is aggressive. To optimize results, you need to follow a series of guidelines strictly. The current standard treatment regimen for resectable pancreatic adenocarcinoma is based on surgery plus adjuvant chemotherapy. With all this, the survival rate at five years after surgery is not greater than 7%, and in addition, there is a high percentage of patients who experience metastatic disease after surgical resection with curative intent. This indicates that at the time of diagnosis, it is likely that most adenocarcinomas pancreatic diseases have progressed to systemic spread. For this reason, for years there is a growing interest in investigating new therapeutic approaches, such as the role of neoadjuvant therapy.

Evaluation of Prognosis With Integrated MRI/PET in Patients With Pancreatic Cancer

The aim of this study was to evaluate MR/PET with both functional and molecular imaging on the prediction of prognosis in patients with suspected pancreatic cancer.

UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer

RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with fluorouracil in treating patients who have metastatic pancreatic cancer that has not responded to treatment with gemcitabine.

A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer

The purpose of this study is to determine if imexon in combination with gemcitabine could improve overall survival as compared to gemcitabine alone in subjects with pancreatic cancer that has spread to other organs such as the liver or lungs. The study will also look at the safety of the combination as compared to gemcitabine alone. Participants in the study will be randomly assigned to either treatment and neither the participant or their doctors will know which treatment they will be receiving.

Adjuvant Effect of Chloroquine on Gemcitabine

The purpose of this study is to evaluate the safety by defining the maximum tolerated dose (MTD) of Choloroquine when combined with Gemcitabine, and to evaluate preliminary efficacy of combined systemic Gemcitabine and Chloroquine. In addition, the influence of the treatment on the anti-cancer immunity and the value of GOLPH2 as serum marker for pancreatic cancer will be assessed within a translational objective.

* Trial with medicinal product

Contrast-enhanced Ultrasound and Pancreatic Lesions

The characterization of pancreatic lesions is one of the fundamental steps in the management of pancreatic neoplastic diseases. In terms of a subjective assessment of vascular enhancement in the various examination stages, the use of contrast-enhanced ultrasonography (CEUS) in the study of pancreatic neoplastic disease has been thoroughly investigated. Technology advancements have enabled the development of software that can perform an objective study of the parameters of vascular enhancement and their variations during dynamic CEUS (DCEUS). Currently, the paucity of data regarding the characterization of pancreatic lesions trough DCEUS limit the definition of its role in pancreatic disease. The main purpose of this study is to employ the knowledge in this field trough the characterization of focal pancreatic lesions using DCEUS.

Observational Study of Quality of Live in Patients With Metastatic Pancreatic Cancer

This is an observational, post-authorization, prospective follow-up, multi-centre, national study designed to describe the spectrum of health-related quality of life in patients with metastatic pancreatic cancer previously untreated with chemotherapy This study is designed to observe patients treated in routine clinical practice, without the exclusion limitations of a clinical trial. Patients will be enrolled in 7 Spanish sites. In all cases, the decision to treat patients will be performed prior to the decision to include the patient in the study.

Given the observational nature of the study, follow-up of patients will be performed according to standard clinical practice of each site.

A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors

The purpose of this study is to confirm the safety and tolerability of TAK-931 in a cohort of Western participants with metastatic solid tumors and to evaluate the anti-tumor activity of TAK-931 in participants with metastatic pancreatic cancer, colorectal cancer (CRC), squamous esophageal cancer (sqEC), and squamous non-small-cell lung cancer (sqNSCLC).

CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with locally advanced or metastatic pancreatic cancer