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Carcinoid Tumor clinical trials

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NCT ID: NCT05477576 Active, not recruiting - Clinical trials for Neuroendocrine Tumors

Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

ACTION-1
Start date: March 24, 2022
Phase: Phase 3
Study type: Interventional

This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity [HA]-DOTATATE.

NCT ID: NCT05448157 Active, not recruiting - Clinical trials for Neuroendocrine Tumor of Pancreas

68Ga-DOTATOC Radio-Guided Surgery With β-Probe in GEP-NET

RGS-GEP-NET
Start date: May 12, 2022
Phase:
Study type: Observational

In gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs), radical surgery provides good long-term outcome and low recurrence rates. In GEP-NETs the actual surgical planning is established on the ground of preoperative morphology images (CT scan), and functional imaging using CT/PET with 68Ga-DOTA-TOC, since the high expression of somatostatin receptors (SSR) of these tumors. RGS in GEP-NETs, mainly with gamma-probes, has been not widely accepted since the low rates of sensitivity and, in particular, specificity, in discriminating tumoral/ non tumoral tissue and background ratio. This is a relevant issue in particular in detecting metastatic lymph-nodes both for small-intestine neuroendocrine tumors (SI-NETs) and pancreatic neuroendocrine tumors (Pan-NETs), where the presence of lymph-node metastases has been associated with worse long-term outcome. At present, it is not possible to distinguish whether a small lymph-node is site of metastases or not without performing frozen sections. In a previous study ex-vivo from European Institute of Oncology SI-NET presented a high uptake of a beta-emitting radiotracer, 90Y-DOTA-TOC. Five SI-NET showing SSR positivity at PET with 68Ga DOTA-TOC received 5 mCi of 90Y-DOTA-TOC the day before surgery. All the tumor samples showed high counts of radioactivity with a sensitivity of 96% and a specificity of 100%. These results allowed the investigators to develop a probe, which is now approved for in-vivo employment within the operating theatre. The objective of the present study is to verify in-vivo within the abdominal cavity the capability of the probe to detect 68-Ga activity within tumoral tissue thus favouring radical surgery and avoiding unnecessary demolition, in the near future. However, in the present protocol the entity of surgery will not be modified by intraoperative findings of the probe. It is reasonable to assume that results from 68Ga-DOTA-TOC might be comparable to 90Y-DOTA-TOC as radiotracer, and the detection efficacy of the probe for 68Ga could be not inferior compared to the isotope 90Y. However, while 90Y-DOTA-TOC is used as investigational drug for therapy purposes only within clinical research protocol, 68Ga-DOTA-TOC is a diagnostic radiotracer broadly used in day-to-day clinical practice since many years. Furthermore, the administration of 68Ga-DOTA-TOC can be directly injected in surgery room and thus does not require patients' admission the day before surgery.

NCT ID: NCT05361668 Active, not recruiting - Carcinoid Tumor Clinical Trials

Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome

Start date: June 17, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome. This study consists of a Randomized Treatment Phase followed by an Open-Label Extension (OLE) Phase.

NCT ID: NCT05064514 Active, not recruiting - Clinical trials for Tricuspid Regurgitation

Investigation of a Transcatheter Tricuspid Valved Stent Graft in Patients With Carcinoid Heart Disease

TRICAR
Start date: April 6, 2022
Phase: N/A
Study type: Interventional

The purpose of this investigation is to see if the TRICENTO Valved Stent Graft implant reduces tricuspid regurgitation (TR) and improves the symptoms and quality of life in 15 participants with carcinoid heart disease, and who are not able to have a new valve via a surgical procedure.

NCT ID: NCT03950609 Active, not recruiting - Clinical trials for Neuroendocrine Neoplasm

Lenvatinib and Everolimus in Treating Patients With Advanced, Unresectable Carcinoid Tumors

Start date: July 30, 2019
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well lenvatinib and everolimus work in treating patients with carcinoid tumors that have spread to other places in the body (advanced) and cannot be removed by surgery (unresectable). Lenvatinib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT03375320 Active, not recruiting - Carcinoid Tumor Clinical Trials

Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors

Start date: October 26, 2018
Phase: Phase 3
Study type: Interventional

This phase III trial studies cabozantinib to see how well it works compared with placebo in treating patients with neuroendocrine or carcinoid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.

NCT ID: NCT03110978 Active, not recruiting - Clinical trials for Neuroendocrine Carcinoma

Stereotactic Body Radiation Therapy With or Without Nivolumab in Treating Patients With Stage I-IIA or Recurrent Non-small Cell Lung Cancer

Start date: June 26, 2017
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well stereotactic body radiation therapy with or without nivolumab works in treating patients with stage I-IIA non-small cell lung cancer or cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving stereotactic body radiation therapy and nivolumab may work better at treating non-small cell lung cancer.

NCT ID: NCT02795858 Active, not recruiting - Carcinoid Tumors Clinical Trials

A Phase II Study of Ramucirumab With Somatostatin Analog Therapy in Patients With Advanced, Progressive Carcinoid Tumors

Start date: June 14, 2016
Phase: Phase 2
Study type: Interventional

This research study is evaluating the drug Ramucirumab as a possible treatment for Advanced, Progressive Carcinoid Tumors.

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: NCT02441088 Active, not recruiting - Neuroblastoma Clinical Trials

Theranostics: 68GaDOTATOC and 90YDOTATOC

PRRT
Start date: May 2015
Phase: Phase 2
Study type: Interventional

Participants in this research study have tumors that express somatostatin receptors such as neuroendocrine tumors, medulloblastoma, meningioma, and neuroblastoma. Approximately 64 people will participate in this study conducted at the University of Iowa.