Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361784
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-08
Brief Title:
Improving the Success Rate for Thoracic Radiotherapy Through Specific Cardiac Substructure Dosimetry Location Matters LOCATION MATTERS
Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Organization:
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Study Overview
Official Title:
Improving the Success Rate for Thoracic Radiotherapy Through Specific Cardiac Substructure Dosimetry Location Matters - a Prospective Study
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LM
Brief Summary:
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
Detailed Description:
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 studys aim is to associate the most radiosensitive functional parameters or biomarkers ie 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 ie 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 13
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 studys aim is to associate the most radiosensitive functional parameters or biomarkers ie 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 ie 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 13
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MFAG27480 | OTHER_GRANT | AIRC Foundation for Cancer Research in Italy | None |