Recruiting
Early Phase 1

18F-NaF PET

Sponsor:

Katelyn Atkins

Code:

NCT06373497

Conditions

Oligometastatic Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18-F-NaF Cardiac PET/MRI and

CT Angiogram

Study Details

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 ID

NCT06373497

Start date

Jun 19, 2025

Status verified date

Aug, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single Arm

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

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

CT Angiogram

All eligible subjects will receive CT Angiogram at baselin

Primary outcome measure

  • Feasibility of using F-NaF PET/MRI imaging [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Clinical Trial Navigator

310-423-5842GroupCancerTrialInformation@cshs.org

Locations

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Clinical Trial Recruitment Navigator

310-423-5842GroupCancerTrialInformation@cshs.org

Principal Investigator:

Katelyn Atkins, MD, PhD

More Information

Sponsor

Katelyn Atkins

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Thoracic Radiotherapy
  • PET Imaging
  • MRI Imaging
  • 18 F-NaF
  • Clinical Stage II
  • Clinical Stage III

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Katelyn Atkins on 2026-08-06.