Real-time imaging of atherosclerosis activity after radiation therapy for cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to utilize fluorine 18-sodium fluoride (18F-NaF) PET and MRI imaging to assess real-time atherosclerosis activity in patients diagnosed with cancer who are undergoing thoracic radiotherapy. The study will monitor changes in clonal hematopoiesis and evaluate immune-modulatory and metabolic responses following radiation exposure. Eligible participants include adults with Stage II-III or oligo-metastatic stage IV malignancies at high risk for cardiac toxicity due to radiation. The study will provide insights into the cardiovascular effects of thoracic radiation therapy.

Why it matters

Who can join: the full rules

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

Where it's running

• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Katelyn Atkins, MD, PhD — Cedars-Sinai Medical Center
• Study coordinator: Clinical Trial Navigator
• Email: GroupCancerTrialInformation@cshs.org
• Phone: 310-423-5842

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.