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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Katelyn Atkins
Study ID
NCT06373497
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Oligometastatic Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 18-F-NaF Cardiac PET/MRI and — DIAGNOSTIC_TEST
    All eligible subjects will receive 18-F-NaF Cardiac PET/MRI at baseline and 6 months after the completion of radiotherapy where the heart is in the treatment field
  • CT Angiogram — DIAGNOSTIC_TEST
    All eligible subjects will receive CT Angiogram at baselin

Study Details

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.

Key Dates

Start date
Jun 19, 2025
Status verified
May 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Fluorine-18-sodium fluoride (18F-NaF) PET/MRI imaging with CT angiography

Primary Outcome Measure

Feasibility of using F-NaF PET/MRI imaging [ Time Frame: 6 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Clinical Trial Recruitment Navigator
[email protected]
3104232133
Katelyn Atkins, MD, PhD (PRINCIPAL_INVESTIGATOR)
Alan Kwan, MD, MS (SUB_INVESTIGATOR)
Louise Thomson, MD (SUB_INVESTIGATOR)
Andriana Nikolova, MD, PhD (SUB_INVESTIGATOR)
Anja Karlstaedt, MD, Phd (SUB_INVESTIGATOR)
Eric Vail, MD (SUB_INVESTIGATOR)
Celeste Eno, PhD (SUB_INVESTIGATOR)
Stephen Shiao, MD, PhD (SUB_INVESTIGATOR)
Elizabeth McKenzie, PhD (SUB_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Cedars Sinai Medical Center· Los Angeles, CA

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