Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Carcinoma, Non-Small-Cell Lung

Carcinoma

Cardiotoxicity

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Herbal and Botanical

All Drugs and Chemicals

Mace

Nutmeg

Alessandro Cicchetti, PhD

Chiara Casati

The prospective study LOCATION MATTERS aims to investigate the radiation-induced damage to the heart and the cardiovascular system in patients treated with thoracic radiotherapy. Patients enrolled in the study will complete a set of extensive measures at the baseline, end of RT, and 9 months after treatment. Ultrasound exams, CT scans, pulmonary tests and wearable devices will assess functional and morphological parameters and the association with their variation and the dose delivered to the heart substructures and to the normal lung.

A cohort of locally advanced lung cancer patients treated with RT will be enrolled at Fondazione IRCCS Istituto dei Tumori. Comorbidities and cardiovascular risk factors will be recorded for all the patients. Heart substructures will be automatically contoured on each patient to provide details on the dose distribution.

The investigators will plan an extensive set of cardiac tests before, at the end of RT and 8 months after treatment (to assess cardiac remodelling and pt recovery). It will include an electrocardiogram, echo cardio, spirometry, blood circulating biomarkers (Troponin and Natriuretic peptide tests) and cardiac calcium score from CT. In addition, the researchers will include a set of measures by the use of a vascular ultrasound machine. This machine will allow the investigation of subclinical vascular organ damage indicators, including carotid distention and intima-media thickness (descriptor of the carotid inflammatory state), through a simultaneous and automatic procedure from raw imaging data. This guarantees the extraction of highly reproducible and operator-independent features. Finally, the project will provide smartwatch devices to the patients aiming to get longitudinal information on heart rate, breathe per minute, stress level, Pulse Ox and recovery time after customised exercises.

The study's aim is to associate the most "radiosensitive" functional parameters or biomarkers (i.e. the more prone to vary after RT) with the dose delivered to the HSs. First, researchers will analyze the variations of the parameters in patients with doses above and below the identified constraints from the literature. Second, investigators will test whether a dose relationship model can continuously describe the changes for the parameters with statistically significant differences. The primary focus will be the comprehension of the dose response for morphological and functional parameters that are altered chronically, i.e. with more compromised values at the 1-year measurement.

For this study, the investigators estimate to enrol 150 lung cancer patients in 3 years.

Information on the OS and MACEs will be registered during the clinical standard FU.

Researchers expect to fulfil an FU rate of 90% two years after RT completion. Registering MACEs during the FU time will allow to perform a first direct comparison of the competing part of Task 1.3.

Improving the Success Rate for Thoracic Radiotherapy Through Specific Cardiac Substructure Dosimetry: Location Matters. (LOCATION MATTERS)

"Improving the Success Rate for Thoracic Radiotherapy Through Specific Cardiac Substructure Dosimetry: Location Matters - a Prospective Study"

A set of parameters will be assessed through the use of a smartwatch device. Variation with time will be compared to identify risk factors associated to patterns in time evolution.

Quantitative image analysis will be performed on protocol CT scans to assess morphology and tissue composition

A set of ultrasound parameters will be normalised to the individual patient value at the baseline. We will evaluate an acute reaction (end of RT) and a late reaction/recovery assessment at 9 months after RT

MACEs will be evaluated and recorded during patient FU as a no/yes variable

Calcification will be assessed through automatic software able to detect calcifications in the heart based on CT scans. Values will be compared with the baseline

Politecnico di Milano

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Gland and Hormone Related Diseases

Rare Diseases

Adrenocortical Adenoma

Adrenal Gland Neoplasms

Adenoma

Adrenal Cortex Neoplasms

Endocrine Gland Neoplasms

Adrenal Cortex Diseases

Adrenal Gland Diseases

Endocrine System Diseases

Adenoma of the Adrenal Gland

Vasoconstrictor Agents

Respiratory System Agents

Epinephrine

Racepinephrine

Epinephryl borate

CT imaging

Mojca Jensterle, MD, PhD

The data on long term natural history of benign nonfunctioning adrenal tumors (NFATs) are lacking. The aim is to identify clinical characteristics associated with tumor growth and progression to mild autonomous cortisol excess over time.

After being informed about the study, all patients with NFAT given written informed consent will underwent a control visit approximatly 10 years after initial visit at the outpateint clinic at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia. The included patients will be divided in three groups regarding the BMI as follows: BMI \< 25 kg/m2, 25-30 kg/m2 and \> 30 kg/m2. The investigators will assess clinical, and laboratory parameters and CT findings at the follow up visit and compere them to baseline characteristics.

Natural History of NFAI: 10 Year Follow-up Results

Natural History of Benign Nonfunctioning Adrenal Tumors: 10 Year Follow-up Results

To determine if and in how many pateints NFAI progressed to MACE.

NFAI: when cortisol after 1 mg overnight dexamethasone (ODST) suppression test is \< 50 nmol/l and no typical clinical signs of Cushing's syndrome are present. Pheochromocytoma and primary aldosteronism will be excluded.

MACE: when cortisol after 1 mg overnight dexamethasone (ODST) suppression test is \> 50 nmol/l.

To determine the change in size of NFAI on the CT scan (mm).

To determine the change in BMI and its correlation with outcome 1 and 2.

Weight and height will be combined to report BMI in kg/m\^2.

University of Ljubljana, Faculty of Medicine

University Rehabilitation Institute, Republic of Slovenia

University Medical Centre Ljubljana

Clinical Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Improving the Success Rate for Thoracic Radiotherapy Through Specific Cardiac Substructure Dosimetry: Location Matters. (LOCATION MATTERS)	NCT06361784	Locally Advance...		-	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Natural History of NFAI: 10 Year Follow-up Results	NCT04616703	Adrenal Inciden...	CT imaging	18 Years -	University Medical Centre Ljubljana
Natural History of NFAI: 10 Year Follow-up Results	NCT04616703	Adrenal Inciden...	CT imaging	18 Years -	University Medical Centre Ljubljana

Spots Global Cancer Trial Database for mace

Every month we try and update this database with for mace cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mace

Every month we try and update this database with for mace cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mace cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.