Real-time imaging of atherosclerosis activity after radiation therapy for cancer
IT2023-08-ATKINS-ATHERO-RT: Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography
This study is testing whether special imaging can help doctors see how radiation therapy for cancer affects heart health in patients at risk for heart problems.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06373497 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Stage II-III or oligo-metastatic stage IV malignancies who are scheduled to receive thoracic radiotherapy.
Not a fit: Patients with significant renal impairment, known allergies to imaging contrast agents, or those unable to undergo PET or MRI imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of cardiac risks in cancer patients undergoing thoracic radiotherapy.
How similar studies have performed: While this approach is novel in its application of 18F-NaF PET/MRI for this purpose, similar studies have shown promise in assessing cardiovascular risks in cancer patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- 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: 3104232133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.