RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

IT2023-08-ATKINS-ATHERO-RT: Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography

Quick Facts

Study Start:2025-06
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06373497

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Clinical Trial Navigator
CONTACT
3104232133
cancer.trial.info@cshs.org

Principal Investigator

Katelyn Atkins, MD, PhD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars Sinai Medical Center
Los Angeles, California, 90048
United States

Collaborators and Investigators

Sponsor: Katelyn Atkins

  • Katelyn Atkins, MD, PhD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06
Study Completion Date2026-10

Study Record Updates

Study Start Date2025-06
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Oligometastatic Disease