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

NCT06361784 | Recruiting

• 2 other identifiers: INT216-23MFAG27480
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Lung Non-Small Cell Carcinoma

Keywords

cardiotoxicity; adverse events; heart substructures; MACE; subclinical warnings

Outcome Measures

Primary Outcomes (1)

• Variation in eco-cardio and eco-vascular parameters after thoracic radiotherapy

  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

  Baseline - End RT - 9 months after RT completion

Secondary Outcomes (2)

• Major adverse cardiac events post-RT

  Baseline - End RT - 9 months after RT completion

• Increase in cardiac calcification after RT

  Baseline - End RT - 9 months after RT completion

Other Outcomes (2)

• Longitudinal variation of cardiopulmonary functional parameters

  Daily evaluations from baseline to 9 months of FU

• Texture variation in the heart substructures

  Baseline - End RT - 9 months after RT completion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include consecutive NSCLC patients with locally advanced disease treated with RT at Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

You may qualify if:

• Patients with NSCLC
• Patients with locally advanced disease (Stage 3)
• Patients treated with RT at Fondazione IRCCS Istituto Nazionale dei Tumori

You may not qualify if:

• Previous thoracic radiotherapy
• Previous heart surgery

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• Politecnico di Milano: collaborator

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: March 29, 2024
• Primary Completion (Estimated): March 29, 2029
• Study Completion (Estimated): March 29, 2029
• Last Updated: April 15, 2024

Record last verified: 2023-11

Locations

IT (1)