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Neuroendocrine Tumors clinical trials

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NCT ID: NCT04837885 Recruiting - Liver Metastases Clinical Trials

Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases

LUTARTERIAL
Start date: September 24, 2021
Phase: Phase 2
Study type: Interventional

The management of liver metastases in neuroendocrine neoplasms is challenging. Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs (SSA) is one of the most promising therapeutic options. As liver is the most frequent site of metastatic disease, our project proposes to compare administration of radiolabeled SSA by arterial intrahepatic infusion (experimental approach) vs intravenous administration (conventional). Evaluation will be made by (i) comparing 68Ga-DOTA-peptides uptake after intra-hepatic versus intravenous route (imaging), (ii) by evaluating the safety of an additional intra-hepatic administration of therapeutic radiolabeled SSA (therapy).

NCT ID: NCT04810091 Recruiting - Clinical trials for Metastatic Neuroendocrine Neoplasm

Telotristat Ethyl for the Treatment of Carcinoid Heart Disease in Patients With Metastatic Neuroendocrine Tumor

Start date: May 18, 2021
Phase: Phase 3
Study type: Interventional

This phase III trial compares the effect of telotristat ethyl and the current standard of care somatostatin analog therapy or somatostatin analog therapy alone in treating patients with neuroendocrine tumor that has spread to other places in the body (metastatic). Telotristat ethyl and somatostatin analog therapy may help to control carcinoid syndrome and carcinoid heart disease.

NCT ID: NCT04790708 Recruiting - Clinical trials for Neuroendocrine Tumors

Peptide Receptor Radionuclide Therapy (PRRT) in Tumors With High Expression of Somatostatin Receptors (Phase 2)

FENET-2016
Start date: July 2, 2018
Phase: N/A
Study type: Interventional

The rationale behind the purpose of this study lays on: - the evidence that PRRT could represent a valuable treatment for the majority of patients with neuroendocrine tumor (NET) in disease progression, operated or inoperable, presenting lesions expressing somatostatin receptors and for which standard treatments are not already available; - the current impossibility of acquiring on the market radiolabelled analogues of somatostatin used for PRRT with marketing authorisation; - the need to collect a larger case history than in previous studies; - the need to stratify the various histotypes based on the response obtained; - the need to define new treatment schemes that guarantee the maximum efficacy and the lowest possible toxicity - with low cumulative (and per cycle) activities radiopharmaceutical and according to the concept of dose hyperfractionation - with a view to an optimal balance between risk and benefit.

NCT ID: NCT04789109 Recruiting - Liver Metastases Clinical Trials

CapTem Plus Radioembolization for NET Liver Metastases

CapTemY90
Start date: November 2021
Phase: Phase 2
Study type: Interventional

Grade 2 neuroendocrine tumors have an intermediate rate of progression following embolotherapy of liver metastases. The combination of capecitabine and temozolomide has been shown to be an active regimen in this disease. Both drugs are radiosensitizers, and in a safety and feasibility study were combined with yttrium-90 radioembolization with acceptable additive toxicities and better than expected response and duration of disease control. This study expands use of this regimen in a Phase 2 investigation to confirm efficacy of the integrated chemoradiation technique.

NCT ID: NCT04735198 Recruiting - Biliary Stones Clinical Trials

Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor Surgery.

TNE-IDC-COLE
Start date: January 20, 2021
Phase: N/A
Study type: Interventional

The investigators want to study the effectiveness of prophylactic cholecystectomy in patients with midgut neuroendocrine tumor (jejunum, ileum or proximal colon) who require primary tumor surgery. When patients are diagnosed and are tributary to surgical treatment, the tumor might compromise vascularization, and patients need an extensive bowel resection. The patients might also receive medical treatment with somatostatin analogs. The combination of extensive bowel resection and medical treatment might increase gallbladder stones, but patients might not develop biliary stone disease, as in the general population, where 20% of the population have gallbladder stones but only a 10 to 15 % of the population will develop symptoms. The idea comes from the lack of literature about the incidence of biliary Stone disease in patients with midgut NET tumors. It's a multicentric, open-label and randomized clinical trial to evaluate the incidence of biliary stone disease in patients with midgut NET who require primary tumor surgery combined or not to cholecystectomy. Our hypothesis suggests that patients with midgut neuroendocrine tumor who require primary tumor resection without the combination of prophylactic cholecystectomy do not have an increased incidence of biliary stone disease two years after the surgery, regardless of treatment with SSA.

NCT ID: NCT04720391 Recruiting - Bone Metastases Clinical Trials

Bone Metastases in neurOendocrine NEoplasms: naTural History, Prognostic Impact and Therapeutic Approach (MONET)

MONET
Start date: January 8, 2021
Phase:
Study type: Observational

This is a retrospective/prospective observational multicentric trial on patients with bone metastases from NENs. General objectives: - To trace on a national scale the frequency of bone metastases in patients with neuroendocrine neoplasm (NEN) and their clinical management. - To correlate clinical and biological factors to clinical outcomes. - To centralise and to make homogeneous clinical, pathological, instrumental and therapeutic information. - To set up a database and to acquire biological material for studying predictive and prognostic biomarkers.

NCT ID: NCT04706910 Recruiting - Parkinson Disease Clinical Trials

18F-DOPA II - PET Imaging Optimization

Start date: January 20, 2021
Phase: Phase 3
Study type: Interventional

A single centre non-randomized, non-blinded phase III prospective cohort study of 18F-DOPA PET/CT imaging in specific patient populations: 1. Pediatric patients (less than 18 years old) with congenital hyperinsulinism. 2. Pediatric patients (less than 18 years old) with neuroblastoma. 3. Pediatric (less than 18 years old) or Adult patients (18 or older) with known or clinically suspected neuroendocrine tumor. 4. Adult patients (18 or older) with a clinical suspicion of Parkinson's disease or Lewy body dementia. 5. Pediatric (less than 18 years old) or Adult patients (18 or older) with brain tumors. Image optimization (the primary study objective) and gallbladder activity pattern (the secondary objective) will be evaluated.

NCT ID: NCT04696042 Recruiting - Clinical trials for Neuroendocrine Tumors

Asian Investigation of Lanreotide Autogel® in the Management of GEP-NETs

AIM-NETs
Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

Lanreotide Autogel® has been established as a standard of care for patients with locally advanced or metastatic GEP-NETs based on the success of CLARINET trial. However, only few patients with Asian ethnicity were included in the trial. According to the nationwide comprehensive study of patients with GEP-NET in Korea, hindgut primary NETs(Rectal) occured more frequently than western countries. However, small intestine or lung primary NET is relatively rare compared with western countries.1) Considering the clinical characteristics of GEP-NETs are distinct between the patients in Asian and Western countries, further evaluation on the efficacy and safety of Lanreotide Autogel® in Asian patients with GEP-NETs is needed.

NCT ID: NCT04665739 Recruiting - Clinical trials for Lung Neuroendocrine Neoplasm

Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors

Start date: February 3, 2023
Phase: Phase 2
Study type: Interventional

This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.

NCT ID: NCT04622631 Recruiting - Clinical trials for Neuroendocrine Tumors

Using 18F- FDG,18F-DOPA and 68Ga-DOTATATE PET/CT in Detection and Evaluation of Response in Patients With NET Undergoing PRRT

Start date: November 2020
Phase:
Study type: Observational [Patient Registry]

the investigators will follow up after patients with neuroendocrine tumors who undergo PRRT treatment and evaluate the response for treatment using PET/CT with different tracers