Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Neuroendocrine

Neuroendocrine Tumors

Carcinoid Tumor

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Somatostatin

Lutetium Lu 177 dotatate

Radiopharmaceuticals

177Lu-Octreotate (LuTate) P-PRRT will be administered as follows:

* Renal absorbed radiation dose will be prescribed for the 4-cycle induction course (23 Gy) and for each subsequent cycle (6 Gy), with a reduction in cases of impaired renal or bone marrow function, or significant toxicity from prior cycles.
* The personalized activity to be administered at each cycle will be derived from renal dose per unit of injected activity that is predicted by patient characteristics or renal dose delivered during prior cycle(s).
* Participants responding to the induction course of P-PRRT will be eligible to receive additional consolidation and/or maintenance cycles.
* Participants with prior PRRT exposure outside the trial may receive less induction cycles, or only consolidation/maintenance cycle(s).

* The induction course will consist in 4 cycles at 8-10 weeks intervals.
* Concomitant amino acids will be administered for renal protection.
* Intra-arterial LuTate administration will be allowed in suitable cases.
* Dosimetry will be based on quantitative SPECT/CT imaging.
* In patients with hormonal symptoms, somatostatine analogues can be given between P-PRRT cycles.

177Lu-Octreotate

Jean-Mathieu Beauregard, MD,MSc,FRCPC

Geneviève Filion

François-Alexandre Buteau, MD, FRCPC

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.

A prospective, single-center, non-comparative, open phase 2 study. In this study, personalized peptide receptor radionuclide therapy (P-PRRT) with 177Lu-Octreotate (LuTate) will be administered to patients with progressive and/or symptomatic inoperable neuroendocrine tumors (NET) of any origin expressing the somatostatin receptor.

The primary objective to assess the objective response rate at 3 months following a four-cycle induction course of P-PRRT will be assessed for at least the first 85 participants.

This study as a compassionate aim to provide access to personalized PRRT patients at CHU de Québec - Université Laval center, and therefore this study has no pre-determined recruitment period duration or limited number of participants, and may remain open as long as necessary to fulfill this aim.

The study will continue until all participants have completed a minimum follow-up of 5 years. Interim analyses will be conducted annually.

Personalized PRRT of Neuroendocrine Tumors

Personalized Peptide Receptor Radionuclide Therapy of Neuroendocrine Tumors: A Phase 2 Study

Correlation between cumulative absorbed radiation dose to tumor lesions and 3-month objective response rate, as defined above

Correlation between cumulative absorbed radiation dose to tumor lesions and survival endpoints above (PFS and OS)

Correlation between cumulative absorbed radiation dose to kidney and variations in glomerular filtration rate from baseline, reported annually for at least 5 years after first cycle or until study completion.

Correlation between cumulative absorbed radiation dose to bone marrow and chronic variations of blood counts from baseline, reported annually for at least 5 years after first cycle or until study completion.

Correlation between per-cycle absorbed radiation dose to bone marrow and subacute variations (nadir values between 2 and 6 weeks) of blood counts from baseline, for each cycle.

Primary efficacy endpoint is the objective response rate on contrast-enhanced CT (or MRI) by RECIST criteria (and secondarily by South Western Oncology Group (SWOG) criteria) at 3 months after the 4th induction cycle of P-PRRT, in comparison to pre-treatment scan (within 3 months before commencing P-PRRT).

Progression of disease is defined as the time from first cycle to the date of first documented progression of disease or death due to any cause. Progression of disease is defined by RECIST criteria.

Proportion of participants with improved, stable or worsened NET-related symptoms (frequency and severity), based on participant interviews at baseline and 3 months after completion of induction course.

Proportion of participants with improved, stable or worsened quality of life score by EORTC quality of life questionnaires QLQ-C30 and QLQ-GI.NET21, administered at baseline and 3 months after induction course.

Proportion of participants with improved (decreased by 25% or more), stable or worsened (increased by 25% or more) Chromogranin-A serum levels performed at baseline and 3 months after induction course.

CHU de Quebec-Universite Laval

Gland and Hormone Related Diseases

Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Thyroid Cancer, Medullary

Bone Density Conservation Agents

Vasodilator Agents

Gastrointestinal Agents

Antihypertensive Agents

Sacubitril and valsartan sodium hydrate drug combination

Calcitonin

Salmon calcitonin

Calcitonin Gene-Related Peptide

Katacalcin

Gastrins

Cholecystokinin

Valsartan

Angiotensin Receptor Antagonists

First intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N without and second injection with additional medication of Sacuitril (100 mg Entresto)(crossover)

First intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and second injection without additional medication of Sacuitril (100 mg Entresto)(crossover)

Intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and without co-medication with Sacuitril (100 mg Entresto) in each patient

177Lu-PP-F11N

Medication with Sacuitril (100 mg Entresto) additional to the injection of 177Lu-PP-F11N

Sacuitril

Christof Rottenburger, Dr. med.

Damian Wild, PhD Dr

The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on more than 90 % of medullary thyroid carcinomas.

A phase 0 study (Lumed study part A) was already performed, showing low toxicity of 177Lu-PP-F11N and tumor uptake in all patients. Co-injection of Physiogel (Gelofusin) showed insignificant reduction of kidney uptake and can therefore be omitted for a radionuclide therapy with 177Lu-PP-F11N. In this study, the effect of the NEP-1 inhibitor Sacuitril on the in-vivo stability of 177Lu-PP-F11N and the uptake, respectively radiation doses in MTC metastases and organs will be evaluated, using a cross-over design already used for the Lumed part A study. Each patient will receive two injections of 177Lu-PP-F11N, with and without additional medication with Sacuitril Imaging findings, acquired by SPECT/CT, will be compared to imaging with 68Ga-DOTATOC positron emission tomography (PET)/CT. The inclusion of 8 patients is planned.

Group 1 patients will receive first 177Lu-PP-F11N alone, second 177Lu-PP-F11N in combination with Sacuitril. Group 2 patients will first receive 177Lu-PP-F11N in combination with Sacuitril, second 177Lu-PP-F11N alone. Affiliation of patients to Groups 1 and 2 will be randomised.

177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer

177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer (Lumed Phase 0/B)

Chromogranin A blood values will be compared to the radiation doses of the stomach.

Comparison of tumor imaging by 68Ga-DOTATOC PET/CT and 177Lu-PP-F11N SPECT/CT

Evaluation of the radiation doses in tumor tissue from MTC after injection of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto)

Evaluation of the radiation doses in the kidneys and the tumor-to-kidney dose ratios after injection of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto)

Evaluation of the radiation doses in other organs and the appropriate organ-to-kidney dose ratios after injection of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto)

Measurement (HPLC) of the in-vivo stability of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto).

In case of surgery with available tumor tissue samples, imaging results will be compared with autoradiographic analysis of somatostatine- and CCK2-receptor expression in tumor tissue.

Krebsforschung Schweiz, Bern, Switzerland

Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland

University Hospital, Zürich

University Hospital Freiburg

University Hospital, Basel, Switzerland

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Lung Neoplasms

Thymoma

Thymus Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Hormones

Hormone Antagonists

Phase 0: 6 patients, intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and without Physiogel (crossover)

Phase I: expected 12 - 18 patients, intravenous application of max. 6 x 7-8 GBq 177Lu-PP-F11N (increasing number of applications by one in groups of three patients). All patients with or without Physiogel, depending on the results of the phase 0 study.

Damian Wild, Prof Dr Dr

The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on more than 90 % of medullary thyroid carcinomas.

In the pilot (phase 0) study investigators will correlate the tumour detection rate with the surgery and histology (proof of concept study). Furthermore, kidney protection and dosimetry studies will be performed in order to determine the kidney protection protocol and starting activity for the dose escalation study in the following, dose escalation (phase I) study. In the phase I study investigators will determinate the maximum tolerated dose of 177Lu-PP-F11N in patients with MTC. Furthermore, correlation with tumour radiation dose and treatment response as well as organ radiation doses and maximal tolerated dose will be performed in order to allow prospective individual patient tailored therapy planning. In the phase I study, participation is additionally possible for patients with well differentiated GEP-NET (grade 1-3) with a Ki67 index of up to 55% or NET of the lung or thymus (grade 1 and 2).

177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer.

177Lu-PP-F11N for Receptor Targeted Therapy and Imaging (Theranostics) of Metastatic Medullary Thyroid Cancer - a Pilot and a Phase I Study.

Phase 0 study: Evaluation of the scintigraphic visualisation of metastases after test injection, verification of 177Lu-PP-F11N uptake in metastases and correlation with surgery/histology if possible (poof of principle study).

Phase I study: Determination of the maximum tolerated dose (MTD)

Evaluation of the kidney radiation dose and the tumour-to-kidney radiation dose ratios with and without kidney protection (Physiogel). Composite measure.

Calculation of tumour and organ radiation doses.

Evaluation of in vivo stability of 177Lu-PP-F11N.

Measurement of the metabolites of 177Lu-PP-F11N with and without Physiogel infusion.

Evaluation of side reactions of 177Lu-PP-F11N.

Evaluation of biochemical response (decrease of calcitonin and calculation of calcitonin doubling time).

Evaluation of morphological therapy response (RECIST criteria).

Determination of the tumour detection rate and correlation with surgery/histology, if possible.

Calculation of organ radiation doses after therapy and correlation with the determined MTD (composite measure).

Determination of overall survival of patients after therapy.

Measurement of the metabolites of 177Lu-PP-F11N.

The injection volume will be up to 5 mL over 20 seconds with an activity of 10 MBq/kg body weight (range between min. 500 and max. 800 MBq). To ensure application of the complete activity additionally 10 mL of 0.9% saline will be infused via the same system.

only one arm - the administration of \[99mTC\]-Tc-TECANT1 in all patients included

[99mTc]Tc-TECANT1

Alicja Hubalewska-Dydejczyk, Prof.

The main goal of the study is to expand cancer preclinical research results on the usefulness of SSTR2-Antagonist \[99mTc\]Tc-TECANT1 in clinical practice. Detection of NEN and monitoring of response to therapy is still challenging due to their cellular heterogeneity. Initial preclinical studies suggest that NEN imaging with the use of SSTR2-Antagonist may be advantageous in comparison to the widely used SSTR2-Agonists.

Recently, novel radiopharmaceuticals, based on SSTR2-Antagonists, were shown to provide superior SSTR2 visualisation than currently used agonists. The need for molecular imaging of NEN is expected to grow significantly in the near future due to their increasing incidence and prevalence. Although a persistent trend to shift the molecular imaging of NEN from conventional SPECT/CT gamma cameras to PET/CT has been observed in the last decade, labelling the compound with Tc-99m offers significant advantages by its extremely wide availability, low cost and low radiation exposure to patients. Effective and accessible molecular imaging methods as an integral part of personalised patient management are needed to optimise selection and follow-up of available therapeutic modalities. The Tc-99m-labeled SSTR2-Antagonist \[99mTc\]Tc-TECANT1 is expected to be an effective, widely available compound for quantitative assessment of SSTR2 NEN status, allowing a personalised therapeutic approach.

Neuroendocrine neoplasms (NEN) are a heterogeneous group of malignancies that arise from various endocrine glands, endocrine cells within non-endocrine tissue and diffuse endocrine cells of the gastrointestinal, respiratory and genitourinary tract. Detection of NEN and monitoring of their response to therapy is challenging due to their varied location (often-unknown primary focus) and cellular heterogeneity. NEN exhibit a wide range of histological appearances and biological behaviors, and may all potentially behave in an aggressive manner, irrespective of the initial diagnosis. Consequently, the prediction of clinical outcomes in an individual patient is often difficult and inaccurate. According to some national registries, the incidence of NEN increased more than 6-fold and the prevalence more than 8-fold between 1973 and 2012, making NEN the second most prevalent diagnosis in gastrointestinal malignancies, thus representing a growing challenge. The rise in the incidence can be partly attributed to increased awareness of the disease and better detection methods. Diagnostic imaging is an integral part of the management of patients with NEN by localising the primary or recurrence site, determining the extent of the disease and evaluating response to therapy. Nuclear medicine with single-photon emission tomography (SPECT) and positron emission tomography (PET) is a branch of molecular imaging: in contrast to anatomical imaging, it depicts functional changes and biological characteristics of target tissues, providing a unique insight into the biology of malignant disease, and has established itself as an excellent tool in personalized medicine. The characteristic feature of NEN is an overexpression of somatostatin receptors (SSTR) on cell membranes. Molecular imaging techniques utilise the ability of SST analogues labelled with radioactive (single-photon or positron emitting) nuclides to bind to the SSTR. A combination of molecular and anatomical imaging (hybrid imaging, SPECT/CT and PET/CT) is currently the most sensitive approach to visualisation of SSTR-positive tumours. In NEN patients the prognosis depends on the grade and stage of the tumour. However, SSTR expression determines not only efficacy of staging using molecular imaging methods, but also efficacy of antiproliferative therapy with SST analogues both not radiolabelled ("cold") and labelled with a therapeutic radionuclide thus enabling Peptide Receptor Radionuclide Therapy (PRRT) as the main approach to personalised NEN patients' management. Traditionally, radiolabelled SST analogues were constructed aiming at their agonistic behaviour, based on their internalisation after SSTR activation and consequent retention within the tumour cells, believed to be crucial for efficient molecular imaging and therapy. Recently, it has been shown that novel molecular probes, SSTR antagonists, recognise more binding sites and hence improve diagnostic efficacy, especially when the density of SSTR is low. Accumulating preclinical and clinical data using both SPECT and PET tracers shows that high-affinity SSTR antagonists can provide better SSTR visualisation than agonists. Preclinical data and subsequent clinical evaluation demonstrated higher tumour uptake of an In-111-labelled antagonist \[111In\]In-DOTA-sst2-ANT (\[111In\]In-DOTA-BASS) compared to the agonist \[111In\]In-DTPA0-octreotide or \[111In\]In -DTPA0-octreotate, as well as superior tumour-to-background ratios. One of the first reports describing the SSTR2 antagonist LM3 indicates the high potential of gallium-68 (Ga-68) and copper-64 (Cu-64) radiolabelled LM3 in PET/CT. The authors demonstrated strong dependence of the affinity and pharmacokinetics of the SST-based radiolabelled antagonists on the chelator and radiometal, also confirmed using another SSTR antagonist, namely JR11. The Superiority of the SSTR antagonist was demonstrated in the Phase I/II clinical study using a positron emitter, \[68Ga\]Ga-NODAGA-JR11 and in a pilot study conducted with beta-emitting, therapeutic radionuclide (lutetium-177, Lu-177) labelled SSTR antagonist \[177Lu\]Lu-DOTA-JR11. As a result, research in the field is currently strongly focused on SSTR antagonists. Ga-68-labelled SST analogues have already established PET as a unique tool for personalising treatment of NEN. Nevertheless, single-photon emitting radiopharmaceuticals still represent the cornerstone of molecular imaging, particularly those based on Technetium-99m (Tc-99m). Its physical properties (half-life of 6 hours, optimal energy of 140 keV for imaging and lowest radiation exposure), widest on-site availability and cost-effectiveness are of major importance for routine clinical applications. Medical diagnostic imaging techniques using Tc-99m account for approximately 80% of all nuclear medicine procedures, representing 30-40 million examinations worldwide every year; even in developed countries, the number of gamma cameras in use exceeds by far the number of PET systems. Considering the above-mentioned characteristics Tc-99m is perfect for research with new radiotracers and is still recognised as the workhorse of diagnostic nuclear medicine. Quantifiable uptake of the radiopharmaceutical in target tissue using standardised methods and metrics such as standardised uptake value (SUV) is currently a unique feature of PET allowing highly personalized approaches to patient management and is part of clinical routine. It was shown also in NEN that the quantitative approach is able to adequately predict and evaluate the response to various treatments available, including "cold" and radiolabelled somatostatin analogues (PRRT). However, single-photon quantitative imaging has developed significantly and is also entering clinical routine. Identical quantitative metrics are becoming available with the use of SPECT/CT systems (SPECT SUV) with comparable accuracy and clinical applicability. The development of a quantitative SPECT imaging approach in NEN, in combination with improved, widely available radiopharmaceuticals, would therefore represent a highly significant improvement in management, tailored to the needs of each individual patient.

Multi-center, Phase 0/I study, prospective single-arm, open-label study

Novel 99mTc-labeled Somatostatin Antaginosts in the Diagnostic Algotithm of Neuroendocrine Neoplasms

Novel 99mTc-labeled Somatostatin Antaginosts in the Diagnostic Algotithm of Neuroendocrine Neoplasms - a Feasibility Study

The number of patients with treatment-related adverse events as assessed by CTCAE v.5.0 (time frame: 2 weeks after administration)CTCAE v.5.0 (time frame: 2 weeks after administration)

Effective dose counted based on absorbed dose (energy deposited per unit mass) adjusted for radiation type and relative organ sensitivity measured in sievert (Sv)

Assessment of effective absorbed dose per injected activity \[mSv/MBq\] for critical organs (bone marrow, kidneys, bladder wall) and neoplastic lesions

1. Calculation of biological half-life of Tc-99m -SSTR2-Antagonist \[99mTc\]Tc-TECANT1 in blood (min) (based on time-activity curves)
2. Assessment of the biological half-life of Tc-99m-SSTR2-Antagonist \[99mTc\]Tc-TECANT1 (min) in normal organs, tumour lesions (based on time-activity curves)

Diagnostic accuracy assessed as the number of neoplastic lesions detected with \[99mTc\]Tc-TECANT1 in comparison to the number of lesions detected with (\[68Ga\]Ga-DOTA-TATE PET/CT)

Medical University Innsbruck

NCBJ Polatom: Narodowe Centrum Badań Jądrowych Polatom

University of Ljubljana

University Medical Centre Ljubljana

Jagiellonian University

Professor

Patients who received treatment of gastroenteropancreatic primary NETs with PRRT per the treating physicians discretion.

a molecular therapy (also called radioisotope therapy) used to treat a specific type of cancer called neuroendocrine tumors or NETs

Peptide Receptor Radionuclide Therapy

Colette N Ndjom, MS

Loretta W Bedell, MPH

Alejandro Mejia, MD

The specific aim is of this study is to gain a better understanding of the patient characteristics, treatment responses, survival outcomes, and adverse events associated with PRRT in patients with gastroenteropancreatic primary NETs.

Neuroendocrine tumors (NETs) make up a large range of malignancies that arise from neuroendocrine cells in multiple organs of the body. Hallet et al conducted a large population-based study that demonstrated that 21% of NET patients presented with metastatic disease and another 38% developed metastases after resection of the primary tumor (Hallet et al., 2015). This burden demonstrates the need for effective systemic therapy for advanced NETs. Options for systemic therapy include peptide receptor radionuclide therapy (PRRT).

A need for more prospective series are needed on treatment responses and survival outcomes related to gastroenteropancreatic primary NETs treated with PRRT was identified. Thus the purpose of this study is to collect clinical data related to treatment of gastroenteropancreatic primary NETs s with PRRT. Clinical data related to patient characteristics, treatment responses and survival outcomes related to the treatment of gastroenteropancreatic primary NETs with PRRT and on adverse events and complications related to PRRT treatment will be collected.

Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors

Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine

(such as age at diagnosis, sex, history of smoking alcohol use and symptoms at the time of diagnosis)

Tumor site, tumor grade, stage, presence of tumor necrosis, number of mitoses and percentage of Ki-67 and MIB-1 positive cells (proliferative index)

at the time of PRRT, location, isotope used and dose of isotope for each PRRT

at the time of diagnosis, before and after the first PRRT, and after the second PRRT were also extracted

prior to PRRT and response after PRRT, date of progression on imaging after PRRT, and status of disease on imaging at the last follow-up were also recorded

the time from diagnosis to death of any cause.

the time from the first PRRT until any progression on diagnostic imaging

assessed with cross-sectional imaging with either computerized tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET) or single-photon emission computed tomography (SPECT).

any increase in lesion sizes and/or appearance of new metastatic lesions on diagnostic imaging exams.

will be assessed by the investigator who will determine whether or not the event is related to PRRT or related to progression of disease (gastroenteropancreatic primary NET), and whether or not the event meets serious criteria. AEs related to PRRT will be recorded in the study registry.

Methodist Health System

Symptoms and General Pathology

Substance Related Disorders

Syndrome

Diarrhea

Malignant Carcinoid Syndrome

Serotonin Syndrome

Signs and Symptoms, Digestive

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Carcinoid Syndrome

Telotristat ethyl, 250 mg, PO, three times daily, continuous.

+ Peptide Receptor Radionuclide Therapy(PRRT) every 8 weeks

Placebo, PO, three times daily, continuous.

+ Peptide Receptor Radionuclide Therapy(PRRT) every 8 weeks

Telotristat ethyl

Placebo

Chandrikha Chandrasekharan, MD

Al B Benson, MD

The NET-PACS trial is a Prospective Assessment of patients with neuroendocrine tumors and current or prior history of Carcinoid Syndrome or diarrhea undergoing peptide receptor radionuclide therapy with or without telotristat ethyl. The main goal of the study is to demonstrate the feasibility of serial in-depth assessment of patients with neuroendocrine tumors and current or prior history of carcinoid syndrome or diarrhea undergoing treatment with PRRT using telotristat ethyl compared to placebo. We aim to report and describe from a patient's perspective the multi-faceted impact of carcinoid syndrome in patients with NETs and the changes on treatment while getting PRRT using telotristat ethyl compared to placebo.

Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl

Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl (NET-PACS Trial) Big Ten Cancer Research Consortium BTCRC-GI19-400

Feasibility of in-depth assessment of changes and improvement on treatment in patients undergoing treatment as determined by FACT-CS global QoL with PRRT using telotristat ethyl compared to placebo. The FACT-CS global QoL is the primary endpoint. Scores will be derived using FACIT guidelines and will range from 0 to 12 with higher scores denoting a better level of functioning.

A repeated measures ANOVA will be applied and statistical significance of fixed effects of treatment arm, time and treatment arm by time interaction will be assessed using a Wilks' Lambda Approximate F test.

Linear mixed effects regression model will be utilized to describe longitudinal changes in QoL as measured by the identified FACT-CS scales. Fixed effects for treatment arm, time and treatment arm by time interaction along with a random effect to account for the longitudinally correlated nature of repeated questionnaire measurements will be included. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced.

Linear mixed effects regression model will be utilized to describe longitudinal changes in QoL Diarrhea domain as measured by the identified FACT-CS scales. Fixed effects for treatment arm, time and treatment arm by time interaction along with a random effect to account for the longitudinally correlated nature of repeated questionnaire measurements will be included. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced.

Linear mixed effects regression model will be utilized to describe longitudinal changes in QoL as measured by the identified FACT-CS scales in the flushing domain. Fixed effects for treatment arm, time and treatment arm by time interaction along with a random effect to account for the longitudinally correlated nature of repeated questionnaire measurements will be included. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced.

Linear mixed effects regression model will be utilized to describe longitudinal changes in frequency of rescue short acting somatostatin receptor antagonist use. Fixed effects for treatment arm, time and treatment arm by time interaction along with a random effect to account for the longitudinally correlated nature of repeated questionnaire measurements will be included. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced.

Linear mixed effects regression model will be utilized to describe longitudinal changes in weight. Fixed effects for treatment arm, time and treatment arm by time interaction along with a random effect to account for the longitudinally correlated nature of repeated questionnaire measurements will be included. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced.

Linear mixed effects regression model will be utilized to describe longitudinal changes in frequency and/or changes in consistency of bowel movements. Fixed effects for treatment arm, time and treatment arm by time interaction along with a random effect to account for the longitudinally correlated nature of repeated questionnaire measurements will be included. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Personalized PRRT of Neuroendocrine Tumors	NCT02754297	Neuroendocrine ... Carcinoid Tumor Carcinoma, Neur...	177Lu-Octreotat...	18 Years -	CHU de Quebec-Universite Laval
177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer	NCT03647657	Thyroid Cancer,...	177Lu-PP-F11N Sacuitril	18 Years - 64 Years	University Hospital, Basel, Switzerland
177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer	NCT03647657	Thyroid Cancer,...	177Lu-PP-F11N Sacuitril	18 Years - 64 Years	University Hospital, Basel, Switzerland
177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer.	NCT02088645	Thyroid Cancer,... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ...	177Lu-PP-F11N	18 Years -	University Hospital, Basel, Switzerland
Novel 99mTc-labeled Somatostatin Antaginosts in the Diagnostic Algotithm of Neuroendocrine Neoplasms	NCT05871320	Neuroendocrine ...	[99mTc]Tc-TECAN...	21 Years -	Jagiellonian University
Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors	NCT04090034	Neuroendocrine ...	Peptide Recepto...	18 Years -	Methodist Health System
Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors	NCT04090034	Neuroendocrine ...	Peptide Recepto...	18 Years -	Methodist Health System
Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl	NCT04713202	Neuroendocrine ... Carcinoid Syndr... Diarrhea	Telotristat eth... Peptide Recepto... Placebo	18 Years -	Big Ten Cancer Research Consortium

Spots Global Cancer Trial Database for peptide receptor radionuclide therapy