NCT06373497

Brief Summary

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. 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. 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
5mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jun 2025Oct 2026

First Submitted

Initial submission to the registry

April 11, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 19, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

April 11, 2024

Last Update Submit

May 1, 2026

Conditions

Oligometastatic Disease

Keywords

Thoracic RadiotherapyPET ImagingMRI Imaging18 F-NaFClinical Stage IIClinical Stage III

Outcome Measures

Primary Outcomes (1)

  • Feasibility of using F-NaF PET/MRI imaging

    To determine the feasibility of using 18F-NaF PET/MRI imaging for detection of real-time atherosclerosis activity in patients at high risk of RT-associated cardiac dysfunction.

    6 Months

Secondary Outcomes (1)

  • Incidence of MACE

    One Year

Study Arms (1)

Single Arm

EXPERIMENTAL

Fluorine-18-sodium fluoride (18F-NaF) PET/MRI imaging with CT angiography

Diagnostic Test: 18-F-NaF Cardiac PET/MRI andDiagnostic Test: CT Angiogram

Interventions

18-F-NaF Cardiac PET/MRI andDIAGNOSTIC_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

Single Arm
CT AngiogramDIAGNOSTIC_TEST

All eligible subjects will receive CT Angiogram at baselin

Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Study Officials

  • Katelyn Atkins, MD, PhD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Navigator

CONTACT

3104232133GroupCancerTrialInformation@cshs.org

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

April 11, 2024

First Posted

April 18, 2024

Study Start

June 19, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)