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

NCT ID: NCT06373497

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-19
• Study Completion Date: 2026-10-31

Brief 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.

Conditions

Oligometastatic Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Fluorine-18-sodium fluoride (18F-NaF) PET/MRI imaging with CT angiography

Group Type: EXPERIMENTAL

18-F-NaF Cardiac PET/MRI and

Intervention Type: DIAGNOSTIC_TEST

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

CT Angiogram

Intervention Type: DIAGNOSTIC_TEST

All eligible subjects will receive CT Angiogram at baselin

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

CT Angiogram

All eligible subjects will receive CT Angiogram at baselin

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years.
• Have clinical stage II-III or oligo-metastatic stage IV malignancy (any histology) planned to be treated with thoracic radiotherapy (≥30 Gy) where the heart is in the treatment field.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
• Planning to receive standard of care radiotherapy treatment.
• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
• Ability to read, write, and understand English

Exclusion Criteria

• Estimated glomerular filtration rate (eGFR) <45 mL/min/m2 or serum creatinine ≥1.5 mg/dL.
• Patients with a known or previous allergy to iodinated contrast, gadolinium contrast, and/or 18F-NaF tracer.
• Inability to receive PET tracer.
• Inability to receive MRI, requiring sedation for MRI, or prohibitive implant and/or device, including ferromagnetic implants and ferromagnetic foreign bodies.
• Subjects with claustrophobia, problems being in enclosed spaces, or inability to lie supine.
• Subjects that are pregnant or breastfeeding.
• Subjects unable to comply with visit instructions, including inability to lie still, hold breathe, or follow procedure instructions.
• Allergy to animal dander or animal-instigated asthma.
• Any other condition which, in the opinion of the investigator, may make the patient a poor candidate for participation in a clinical trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Katelyn Atkins

OTHER

Sponsor Role: lead

Responsible Party

Katelyn Atkins

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Katelyn Atkins, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Trial Navigator

Role: CONTACT

cancer.trial.info@cshs.org

3104232133

Facility Contacts

Clinical Trial Recruitment Navigator

Role: primary

cancer.trial.info@cshs.org

3104232133

Other Identifiers

IIT2023-08-ATKINS-ATHERO-RT

Identifier Type: -

Identifier Source: org_study_id