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RECRUITING
NCT06373497
EARLY_PHASE1

Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography

Sponsor: Katelyn Atkins

View on ClinicalTrials.gov

Summary

The prospective single-arm pilot study, ATHERO-RT: Real-Time Atherosclerosis Activity after Thoracic Radiotherapy using Sodium Fluoride Positron Emission Tomography, will aim to: 1. To deploy first-in-kind application of fluorine 18-sodium fluoride (18F-NaF) PET (Positron Emission Tomography) /MRI (Magnetic Resonance Imaging) imaging to detect real-time atherosclerosis activity at the time of cancer diagnosis and after cardiac radiation exposure 2. To detect longitudinal changes in clonal hematopoiesis (CH) genetic architecture following thoracic RT (Radiation Therapy) in patients at high risk of cardiac dysfunction, and 3. To measure perturbations in the immune-modulatory and metabolic states following thoracic RT (Radiation Therapy) exposure in patients at high risk of cardiac dysfunction. Eligible patients will be adults (≥18 years old) with Stage II-III or oligo-metastatic stage IV malignancy (any histology) at high risk for RT-associated cardiac toxicity (defined as receiving ≥30 Gy (Gray) RT where the heart is in the treatment field54). The study will enroll a total of 10 subjects, recruited from Cedars-Sinai Medical Center. The primary endpoint will be successful completion of 18F-NaF PET imaging at the baseline and 6-month post-RT time points. Blood will be collected at baseline, end of RT, and 6-months post-RT.

Official title: IT2023-08-ATKINS-ATHERO-RT: Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-06-19

Completion Date

2026-10

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

18-F-NaF Cardiac PET/MRI and

All eligible subjects will receive 18-F-NaF Cardiac PET/MRI at baseline and 6 months after the completion of radiotherapy where the heart is in the treatment field

DIAGNOSTIC_TEST

CT Angiogram

All eligible subjects will receive CT Angiogram at baselin

Locations (1)

Cedars Sinai Medical Center

Los Angeles, California, United States