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

IT2023-08-ATKINS-ATHERO-RT: 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.

Study Overview

• Status: Recruiting
• Conditions: Oligometastatic Disease
• Intervention / Treatment: Diagnostic test: 18-F-NaF Cardiac PET/MRI and; Diagnostic test: CT Angiogram

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Trial Navigator; Phone Number: 3104232133; Email: GroupCancerTrialInformation@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars Sinai Medical Center
      • Sub-Investigator: Stephen Shiao, MD, PhD
      • Principal Investigator: Katelyn Atkins, MD, PhD
      • Sub-Investigator: Andriana Nikolova, MD, PhD
      • Sub-Investigator: Anja Karlstaedt, MD, Phd
      • Sub-Investigator: Celeste Eno, PhD
      • Sub-Investigator: Elizabeth McKenzie, PhD
      • Sub-Investigator: Alan Kwan, MD, MS
      • Sub-Investigator: Louise Thomson, MD
      • Sub-Investigator: Eric Vail, MD
      • Contact: Clinical Trial Recruitment Navigator; Phone Number: 3104232133; Email: GroupCancerTrialInformation@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; Fluorine-18-sodium fluoride (18F-NaF) PET/MRI imaging with CT angiography	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of using F-NaF PET/MRI imaging	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.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of MACE	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.	One Year

Collaborators and Investigators

• Sponsor: Katelyn Atkins
• Investigators: Principal Investigator: Katelyn Atkins, MD, PhD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: PET Imaging; MRI Imaging; Thoracic Radiotherapy; 18 F-NaF; Clinical Stage II; Clinical Stage III
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: IIT2023-08-ATKINS-ATHERO-RT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No