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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NCT ID: NCT04831567 Withdrawn - Clinical trials for Neuroendocrine Tumors

Study of MIBG-I131 in Patients With Well Differentiated Neuroendocrine Tumors

MIBNET
Start date: February 4, 2021
Phase: Phase 2
Study type: Interventional

This is a single-arm, unicentric, single-stage, phase 2 clinical study of therapeutic metaiodobenzylguanidine (MIBG) for patients with metastatic well-differentiated neuroendocrine tumors and radiological progression or intolerance after standard lines of treatment and with MIBG positive scan.

NCT ID: NCT04814732 No longer available - Clinical trials for Neuroendocrine Tumors

Expanded Access Program of Surufatinib

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

This treatment protocol is intended to provide early access of surufatinib to patients with locally advanced or metastatic NETs for whom, in the opinion of their treating physician, other treatment options or surufatinib clinical trials in this indication are unsuitable. This EAP is currently available in the US only.

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: NCT04804371 Active, not recruiting - Clinical trials for Neuroendocrine Tumors

Dual Tracer (68Ga-DOTATATE and 18F-FDG) PET Imaging in G2 & G3 Gastroenteropancreatic Neuroendocrine Tumors

Start date: March 4, 2021
Phase: N/A
Study type: Interventional

The variable clinical outcome of patients with G2 & G3 well diff GEP-NETs makes the selection of an optimal treatment strategy challenging. Initial data suggests that high DOTATATE uptake and low FDG uptake are suggestive of low grade disease, with an indolent course. Conversely, low DT uptake and high FDG uptake are suggestive of high-grade/ aggressive disease. G2/3 GEP NETs may be biologically diverse; clinically relevant cohort for dual-tracer PET imaging. Our secondary objectives are 1. To determine the distribution of PETNET scores derived from 18F-FDG & 68Ga-DT PET in patients with G2 & G3 well diff GEP-NETs. 2. To determine the proportion of patients in whom the addition of 18F-FDG PET data results in a change in planned clinical management. To assess intra-individual variability in SSTR expression & glucose metabolism (as seen on DT and FDG PET) across different tumor sites within the same patient. 2) To determine whether a correlation exists between tumor texture features on 68Ga-DT & FDG PET to tumor grade and Ki 67 index. 3) To assess for an association between tumor texture features on 68Ga-DT PET and glucose metabolism; and/or an association between tumor texture features on FDG PET and SSTR expression.

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: NCT04788927 Not yet recruiting - Clinical trials for Head and Neck Cancer

Development of a Predictive Model for the Risk of Metastatic Disease in PPGLs, a Retrospective Cohort Study

PPGL-Pred
Start date: October 1, 2023
Phase:
Study type: Observational

Phaeochromocytomas and paragangliomas (PPGLs) are tumours of the adrenal medulla and extra-adrenal sympathetic nervous system, some which can become metastatic. It is a very rare disease and the tumours are often detected late. Approximately 50 % of the tumours are caused by germline genetic variants screening programmes are recommended for patients and their family members; however, they are not yet well-targeted with respect to individual prognosis. In this study the investigatorscaim to characterize the genotype-phenotype associations in all Danish patients (n=400) diagnosed with PPGLs who have been followed in tertiary centres using medical records and national registries. To this end novel immunohistochemical, genetic, and epigenetic biomarkers in tumour tissues samples from biobank material (blood samples and tumour tissue) will be investigated to develop a comprehensive predictive algorithm for disease prognosis. The study will provide a clinical tool for an improved targeted screening program and subsequently prevention of disease development.

NCT ID: NCT04780737 Completed - Surgery Clinical Trials

Prophylactic Cholecystectomy is Not Mandatory in Patients Candidate to the Resection for Small Intestine Neuroendocrine Neoplasms: a Propensity Score-matched and Cost-minimization Analysis

Start date: January 2000
Phase:
Study type: Observational [Patient Registry]

To evaluate two competitive strategies in patients undergoing resection of Small-intestine Neuroendocrine neoplasms (Si-NEN): Prophylactic Cholecystectomy (PC) versus On-demand delayed cholecystectomy

NCT ID: NCT04776876 Withdrawn - Carcinoid Syndrome Clinical Trials

Retifanlimab (INCMGA00012) and Telotristat Ethyl for the Treatment of Advanced Neuroendocrine Tumors and Carcinoid Syndrome

Start date: March 1, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial studies the effect of retifanlimab and telotristat ethyl in treating patients with neuroendocrine tumors that have spread to other places in the body (advanced) and carcinoid syndrome. Retifanlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Telotristat ethyl is a drug used to reduce side effects of carcinoid syndrome. Giving retifanlimab and telotristat ethyl may help to control neuroendocrine tumors in patients who also have carcinoid syndrome.