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

Launched by KATELYN ATKINS · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial, called ATHERO-RT, is looking at how radiation therapy for cancer affects the heart and blood vessels in patients who are receiving treatment for specific types of cancer, particularly those at higher risk for heart problems. The study will use special imaging techniques to monitor changes in heart and blood vessel health before and six months after radiation therapy. Researchers aim to understand both the immediate and long-term effects of this treatment on heart health and the body’s immune and metabolic systems.

To participate in this study, you need to be an adult (18 years or older) with certain types of cancer that are planned to be treated with radiation therapy affecting the chest area. You should be in relatively good health and able to follow the study requirements. The trial will enroll 10 patients from Cedars-Sinai Medical Center, and participants will undergo imaging and provide blood samples at different points during the study. It's important to note that the trial is not yet recruiting, and those interested will need to meet specific health criteria to be eligible.

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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