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NCT Number: NCT06373497

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

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.

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Key information

Conditions

Oligometastatic Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Alan Kwan, MD, MS

SUB_INVESTIGATOR

Andriana Nikolova, MD, PhD

SUB_INVESTIGATOR

Anja Karlstaedt, MD, Phd

SUB_INVESTIGATOR

Celeste Eno, PhD

SUB_INVESTIGATOR

Clinical Trial Recruitment Navigator

CONTACT

[email protected]

3104232133

Elizabeth McKenzie, PhD

SUB_INVESTIGATOR

Eric Vail, MD

SUB_INVESTIGATOR

Katelyn Atkins, MD, PhD

PRINCIPAL_INVESTIGATOR

Louise Thomson, MD

SUB_INVESTIGATOR

Stephen Shiao, MD, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18-F-NaF Cardiac PET/MRI and

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

Diagnostic Test

All eligible subjects will receive CT Angiogram at baselin

Primary outcomes

  1. Feasibility of using F-NaF PET/MRI imaging

    Time frame: 6 Months

    To determine the feasibility of using 18F-NaF PET/MRI imaging for detection of real-time atherosclerosis activity in patients at high risk of RT-associated cardiac dysfunction.

Secondary outcomes

  1. Incidence of MACE

    Time frame: One Year

    To measure the one-year cumulative incidence of MACE (Major Adverse Cardiovascular Events). The one-year cumulative incidence of MACE will be estimated, adjusting for non cardiac death as a competing risk. For the secondary endpoint, one-year MACE cumulative incidence will be estimated using the Cumulative Incidence Function (CIF), while accounting for non-cardiac death as a competing risk.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Navigator

CONTACT

[email protected]

3104232133

Sponsors and collaborators

Lead sponsor

Katelyn Atkins

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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