NCT06373497 Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography
| NCT ID | NCT06373497 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Katelyn Atkins |
| Condition | Oligometastatic Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-06-19 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-06-19 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Katelyn Atkins, MD, PhD
PRINCIPAL INVESTIGATOR
Cedars-Sinai Medical Center
Frequently Asked Questions
Who can join the NCT06373497 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oligometastatic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06373497 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06373497 currently recruiting?
Yes, NCT06373497 is actively recruiting participants. Contact the research team at GroupCancerTrialInformation@cshs.org for enrollment information.
Where is the NCT06373497 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06373497 clinical trial?
NCT06373497 is sponsored by Katelyn Atkins. The principal investigator is Katelyn Atkins, MD, PhD at Cedars-Sinai Medical Center. The trial plans to enroll 10 participants.