Symptoms and General Pathology

All Conditions

Neoplasms

Behaviors and Mental Disorders

Rare Diseases

Fatigue

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Quality of Life

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Somatostatin

Lanreotide

Hormones

Hormone Antagonists

Study A:

A cross-sectional study that investigates 250 patients (Cohort A) with neuroendocrine neoplasia, encompassing both patients with neuroendocrine tumors (NET) and neuroendocrine carcinomas (NEC).

Study B:

A prospective study that investigates 30 newly diagnosed NET patients over three months (Cohort B) who are offered palliative treatment with somatostatin analogues.

Somatostatin analog

Gitte Dam

Numerous studies describe HRQoL in other cancer types, whereas only sparse research has been done in NEN patients. We wish to investigate HRQol in NEN patients. Using a validated generic tool with normative values derived from a background population, allows us to compare the values healthy controls.

Methods

Study A:

A cross-sectional study that investigates 250 patients (Cohort A) with neuroendocrine neoplasia, encompassing both patients with neuroendocrine tumors (NET) and neuroendocrine carcinomas (NEC).

Study B:

A prospective study that investigates 30 newly diagnosed NET patients over three months (Cohort B) who are offered palliative treatment with somatostatin analogues.

The diagnosis of cancer and living with cancer has an impact on patients' HRQoL. Numerous studies describe HRQoL in other cancer types, whereas only sparse research has been done in NEN patients.

Previous studies concerning the effect of cancer on HRQoL have been useful and help clinicians regulate treatment regimens in other cancer types. In advanced cancer patients, it is shown that Global QoL, physical, role, and emotional functioning improves during HPN and it wasin patients who are candidates for HPN according to the European guidelines.

Moreover, patients with laryngeal cancer who are offered partial or total laryngectomy experience a significant and fast decline in HRQoL compared to those who are offered transoral laser microsurgery. This study has improved clinician and patient decision-making.

Previous studies investigating HRQoL in NEN patients have methodological limitations; no reference groups, limited number of patients or including a heterogenos group of patietns. This lack of methodological quality may explain the inconsistency in the HRQoL results found in previous NEN studies.To our knowledge, only a few cross-sectional studies of larger patient groups compared to a background population have been published.

Both HRQoL and fatigue are likely to be affected in NEN patients. Using a validated generic tool with normative values derived from a background population, allows us to compare the values healthy controls.

Aim

* To quantify HRQoL and fatigue in a cross-sectional study (Study A) of a large group of patients with NEN
* To investigate the immediate effect of diagnosis and somatostatin-analogue treatment on new patients. A prospective study over the course of three months (Study B)
* To investigate the change in HRQoL and fatigue during follow-up. (a three year follow-up will be performed beyond this research year)

Hypothesis

* HRQoL will be significantly lower and fatigue significantly higher in NEN patients compared to the general population
* HRQoL will be significantly lower and fatigue significantly higher in NEC patients compared to NET patients.
* Newly diagnosed patients with NET starting somatostatin analogue treatment will improve their HRQoL and reduce fatigue after a follow-up period of three months.
* In patients with neuroendocrine neoplasia, HRQoL will remain unchanged in patients with stable disease and derease in patients with disease progression.

Methods

Study A:

A cross-sectional study that investigates 250 patients (Cohort A) with neuroendocrine neoplasia, encompassing both patients with neuroendocrine tumors (NET) and neuroendocrine carcinomas (NEC).

Study B:

A prospective study that investigates 30 newly diagnosed NET patients over three months (Cohort B) who are offered palliative treatment with somatostatin analogues.

Fatigue and Quality of Life in Patients With Neuroendocrine Neoplasia

University of Aarhus

MD, PhD

Disease Progression

Gastro-enteropancreatic Neuroendocrine Tumor

Gastrointestinal Agents

Octreotide

Antineoplastic Agents, Hormonal

Somatostatin analog (octreotide long-acting release (LAR) 30 mg or lanreotide 120 mg) will be given every four weeks for a duration of 18 months.

Somatostatin analog treatment (octreotide LAR 30 mg or lanreotide 120 mg) will be withdrawn for a duration of 18 months.

Somatostatin analog treatment every 4 weeks

Marc U Peeters, MD

Timon Vandamme, MD

Wim Demey

Marijke Ulenaers

Karen Geboes

Willem Lybaert

Chris Verslype

Isabelle Sinapi

Timon Vandamme

Frank Van Fraeyenhove

Isabelle Maurissen

Ioannis Karfis

Ivan Borbath

Laurence Lousberg

Theo Van Voorthuizen

Loes Latten-Jansen

Wouter Dercksen

Heinz-Josef Klumpen

Annemiek Walenkamp

Wouter de Herder

Marc Peeters, MD

The SAUNA trial is a multi-national, multi-centre, open-label, randomised, controlled, pragmatic clinical trial in patients with advanced, non-functional gastroenteropancreatic (GEP) neuroendocrine tumours (NET) with progressive disease on first-line therapy with somatostatine analogues (SSA). Eligible patients will be divided into two substudies according to the second-line therapy of choice (peptide receptor radionuclide therapy (PRRT) or targeted therapy, at the discretion of the local investigator). Patients within each substudy will be randomised 1:1 between continuation or withdrawal from SSA at the start of second-line systemic therapy. Stratification will occur according to study site and according to the Ki67 value (below 10% (grade 1 and low grade 2) and equal to or above 10% (high grade 2)).

Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients - The SAUNA Trial

QoL measurement with 30-item Quality of Life Questionnaire (QLQ-C30)

QoL measurement with 21-item QoL questionnaire in the gut, pancreas and liver neuroendocrine tumours (QLQ-GINET21)

QoL measurement with EuroQol-5 Dimensions-5 Level questionnaire

Health technology assessment (HTA) analysis

Safety will be reported in terms of incidence and severity of (serious) adverse events

Erasmus Medical Center

ZonMw: The Netherlands Organisation for Health Research and Development

Belgium Health Care Knowledge Centre

University Hospital, Antwerp

PET scan with Ga68-DOTANOC

Yodphat Krausz, MD

Arik Tzukert, DMD

Hadas Lemberg, PhD

Imaging of neuroendocrine tumors (NETs) relies on conventional morphological methods and on somatostatin receptor scintigraphy (SRS). SRS is effective for carcinoid tumors, and for most pancreatic islet-cell tumors, but may fail to detect some tumors. Furthermore, this technique may require repeated imaging over 24-48 hours. Introduction of newer somatostatin analogs such as DOTANOC improves lesion detection. In addition, labeling with Ga68 and use of PET/CT improves the pharmacokinetics of the tracer resulting in better tumor visualization, and an easier procedure with imaging over only 1-2 hours.

In this study, we propose to use Ga68-DOTANOC PET for imaging of various NETs, comparing the imaging data to those of anatomical and other functional modalities, and to histopathology, when available.

Neuroendocrine tumors (NETs), best treated by complete surgical resection, are frequently difficult to localize due to small size, presence in hollow organs, and morphological changes caused by prior surgery. Imaging of NETs relies primarily on conventional morphological methods (EUS, CT, MRI, US). Functional imaging, such as somatostatin receptor scintigraphy (SRS) using the In111-labeled somatostatin analog octreotide, provides better staging of the disease, visualization of occult tumor, and evaluation of patient eligibility for somatostatin analog treatment. This modality is effective for carcinoid tumors, and for most pancreatic islet-cell tumors. However, it may fail to detect some tumors, mostly due to low density of somatostatin receptors, with resulting lack of tumor uptake. The relatively poor spatial resolution of planar and SPECT imaging may also reduce tumor detection, particularly for small tumors and/or those with low uptake. Furthermore, this technique is lengthy, often requiring repeated imaging over 24-48 hours. Introduction of newer somatostatin analogs such as DOTANOC offers many advantages. Higher uptake of the newer analogs in more of the somatostatin receptor subtypes improves lesion detection. In addition, labeling with the positron emitter, Ga68, instead of In111 improves the pharmacokinetics of the tracer, and the faster tumor uptake and more rapid clearance from normal tissues increases tumor to background contrast, improving tumor visualization, and resulting in an easier procedure with imaging only 1-2 hours after tracer injection. The superior spatial resolution of positron emission tomography (PET) again enhances lesion detectability, and use of PET makes it possible to perform exact quantitation of tracer uptake that can be useful for monitoring therapy and for planning peptide receptor radionuclide therapy.

In this study, we propose to use Ga68-DOTANOC PET for imaging of various NETs, comparing the imaging data to those of anatomical and other functional modalities, and to histopathology, when available.

Ga68-DOTA-NOC-PET Imaging of Neuroendocrine Tumors

Hadassah Medical Organization

Yodphat Krausz M.D.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fatigue and Quality of Life in Patients With Neuroendocrine Neoplasia	NCT04557137	Neuroendocrine ...	Somatostatin an...	-	University of Aarhus
Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients	NCT05701241	Gastroenteropan...	Somatostatin an...	18 Years -	University Hospital, Antwerp
Ga68-DOTA-NOC-PET Imaging of Neuroendocrine Tumors	NCT00569738	Neuroendocrine ...	PET scan with G...	18 Years -	Hadassah Medical Organization
Ga68-DOTA-NOC-PET Imaging of Neuroendocrine Tumors	NCT00569738	Neuroendocrine ...	PET scan with G...	18 Years -	Hadassah Medical Organization

Spots Global Cancer Trial Database for somatostatin analog