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Neuroendocrine Tumors clinical trials

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NCT ID: NCT02779257 Enrolling by invitation - Clinical trials for Gastro-enteropancreatic Neuroendocrine Tumor

Pasireotide Treatment for Neuroendocrine Tumor

Start date: April 2016
Phase: Phase 4
Study type: Interventional

Pasireotide binds to somatostatin receptors sst2 and sst5, which can lead to significant hyperglycemia. The investigators would like to administer pasireotide as a treatment for refractory hypoglycemia in the setting of metastatic insulin-producing pancreatic neuro-endocrine tumor.

NCT ID: NCT02759718 Active, not recruiting - Clinical trials for Non Functioning Pancreatic Endocrine Tumor

Clinical Effectiveness of Serum Chromogranin A Levels on Diagnostic of Pancreatic Neuroendocrine Tumors

CgA
Start date: June 2012
Phase: Phase 4
Study type: Interventional

Chromogranin A (CgA) is a glycoprotein with a molecular weight of 49 to 52 kDa produced by chromaffin cells of the adrenal medulla, enterochromaffin-like (ECL) cells, and endocrine cells of the stomach and pancreas, and it is the precursor to several functional peptides including vasostatin and pancreastatin. Importantly, CgA can be measured in the serum or plasma or detected within the secretory vesicles as a general diagnostic biomarker for neuroendocrine tumors (NETs), and plasma CgA levels also provide information regarding tumor burden and response to treatment. It has a sensitivity and specificity between 27% and 81%. Some studies have noted an association between CgA concentrations and tumor location or degree of differentiation. It has also been proposed that plasma CgA levels are more frequently elevated in well-differentiated tumors compared with poorly differentiated tumors of the midgut. Some other clinical series have provided evidence of an association between plasma CgA levels and the extent of disease, tumor burden, or presence of metastases, and high baseline levels of CgA are suggestive of a poor prognosis. However, there exist still controversies the effectiveness of serum CgA levels on diagnostic relevance, treatment response after surgical resection or sandostatin analog, clinicopathologic features of pancreatic neuroendocrine tumors (PNETs). To date, moreover, a precise association between CgA levels and survival has not been clearly demonstrated, although a number of studies suggest that this relationship may exist. There, especially, is no relevant data on value of serum CgA level for clinical usefulness in Korean population.

NCT ID: NCT02754297 Recruiting - Clinical trials for Neuroendocrine Tumors

Personalized PRRT of Neuroendocrine Tumors

P-PRRT
Start date: April 2016
Phase: Phase 2
Study type: Interventional

In this study, peptide receptor radionuclide therapy (PRRT) with 177Lu-Octreotate (LuTate) will be personalized, i.e. administered activity of LuTate will be tailored for each patient to maximize absorbed radiation dose to tumor, while limiting that to healthy organs. The purpose of this study is to: - Assess the objective (radiological), symptomatic and biochemical response rates following an induction course of personalized PRRT; - Assess the overall, the disease-specific, and the progression-free survival following P-PRRT; - Correlate therapeutic response and survival with tumor absorbed radiation dose; - Evaluate the acute, subacute and chronic adverse events following P-PRRT; - Correlate toxicity (i.e. occurence and severity of adverse events) with absorbed radiation doses to organs at risk; - Optimize the quantitative SPECT imaging-based dosimetry methods in a subset of 20 patients (sub-study funded by the Canadian Institutes of Health Research). This study also has a compassionate purpose, which is to provide access to PRRT to patients.

NCT ID: NCT02736500 Recruiting - Clinical trials for Neuroendocrine Tumors

PEPTIDE RECEPTOR RADIONUCLIDE THERAPY WITH 177Lu-DOTATATE ASSOCIATED WITH METRONOMIC CAPECITABINE IN PATIENTS AFFECTED BY AGGRESSIVE GASTRO-ENTERO-PANCREATIC NEUROENDOCRINE TUMORS

LuX
Start date: July 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this phase I-II study is to evaluate the efficacy and toxicity of PRRT with 177Lu-DOTATATE (Lu-PRRT) associated to metronomic chemotherapy with Capecitabine in patients affected by aggressive FDG-positive gastro-entero-pancreatic NET. Moreover to analyze the effects of the capecitabine metronomic schedule on the level of circulating angiogenetic factors.

NCT ID: NCT02736448 Not yet recruiting - GEP-NET Tumors Clinical Trials

177Lutethium - Peptide Receptor Radionuclide Therapy (Lu-PRRT) Plus Capecitabine Versus Lu-PRRT in FDG Positive, Gastro-entero-pancreatic Neuroendocrine Tumors

Lu-Ca-S
Start date: April 2016
Phase: Phase 2
Study type: Interventional

This is a randomized phase II, parallel group study. Patients with gastro-entero-pancreatic neuroendocrine tumors (GEP-NET) well differentiated G1 - G2 (ki67≤ 20%) and G3 (ki67≤ 50%), SSR positive and 18-FDG positive will be enrolled in the study and will be randomly assigned to 2 different arms: - ARM 1: oral low dose of capecitabine in association with Lu-PRRT (at 3.7 Gbq per cycle x 7 cycles) followed by long acting octreotide or lanreotide (SS-LAR); OR - ARM 2: Lu-PRRT (at 3.7Gbq per cycle x 7 cycles) followed by SS-LAR.

NCT ID: NCT02730104 Recruiting - Clinical trials for Gastroenteropancreatic Neuroendocrine Tumors

Community-based Neuroendocrine Tumor (NET) Research Study

Start date: November 2015
Phase: N/A
Study type: Observational

The purpose of this trial is to assess time to disease progression of patients with locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors treated with Lanreotide Depot. This is an observational study therefore all data collected will be in accordance with the routine practice of physicians.

NCT ID: NCT02705651 Not yet recruiting - Clinical trials for Pancreatic Neuroendocrine Tumors in MEN1

Non-functioning Pancreatic Neuroendocrine Tumors in MEN1: Somatostatin Analogs Versus NO Treatment

SANO
Start date: June 2016
Phase: Phase 3
Study type: Interventional

A.Background More than 90% of patients with multiple endocrine neoplasia type 1 (MEN1) develop multiple pancreatic neuroendocrine tumors (pNETs). These tumors are the most common cause for premature death in MEN1. While functioning pNETs must be treated to reduce or cure hormonal excess, the procedures for non-functioning pNETs are yet under discussion. Treatment ranges from watchful waiting to subtotal and total pancreatectomy. The latter may represent an "overtreatment", resulting in general complications and diabetic metabolic status. The effect of somatostatin analogues (SAs) has shown promising results with regard to progression of non-functioning duodeno-pancreatic NETs. Treatment with SAs is highly safe and effective, resulting in long-time suppression of tumor growth. B. Aim In this study of MEN1 patients with non-functioning pNETs, the benefits of somatostatin analogs" (SAs; group 1) compared to "no treatment" (group 2) will be analyzed with regard to progression (tumor growth; development of new [functioning and non-functioning] neuroendocrine tumors and regional/distant metastasis). C. Implementation Patients will either receive Somatostatin Analogs (SAs) or no treatment. The observation period will be 60 months. The increase of tumor size and development of new tumors or metastasis will be monitored.

NCT ID: NCT02705313 Available - Clinical trials for Midgut Carcinoid Tumor

Expanded Access Protocol for Therapeutic Use of 177Lu-DOTA0-Tyr3-Octreotate in Patients With Inoperable, Somatostatin Receptor Positive, Midgut Carcinoid Tumors, Progressive Under Somatostatin Analogue Therapy

Start date: n/a
Phase: N/A
Study type: Expanded Access

Advanced Accelerator Applications is currently pursuing marketing approval for 177Lu-DOTA0-Tyr3-Octreotate (Lutathera). Considering that Phase III NETTER-1 clinical trial recruitment has been completed, this expanded access therapeutic protocol aims to allow patients suffering from inoperable, somatostatin receptor positive, midgut carcinoid tumors, progressive under somatostatin analogue therapy to access the investigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.

NCT ID: NCT02698410 Not yet recruiting - Clinical trials for Neuroendocrine Tumours

Efficacy and Safety of Lanreotide Autogel (ATG) in Combination With Temozolomide in Subjects With Thoracic Neuroendocrine Tumors.

ATLANT
Start date: April 2016
Phase: Phase 2
Study type: Interventional

The purpose of the protocol is to evaluate the efficacy and safety of Lanreotide ATG 120 mg in combination with Temozolomide in subjects with unresectable advanced neuroendocrine tumours of the lung or thymus as Disease Control Rate at 9 months.

NCT ID: NCT02693067 Not yet recruiting - Clinical trials for Neuroendocrine Tumors Metastatic to the Liver

A Phase 1 Study of PV-10 Chemoablation of Neuroendocrine Tumours (NET) Metastatic to the Liver

Start date: March 2016
Phase: Phase 1
Study type: Interventional

This study is intended to determine the safety, tolerability and reduction of biochemical markers (Chromogranin A or, if deemed appropriate, 5-hydroxyindoleaceticacid) and troublesome symptoms (particularly diarrhea and flushing) of intralesional injection of PV-10 in subjects with NET metastatic to the liver that are not amenable to resection or other potentially curative therapy.