Oligometastatic DiseaseEarly Phase 1NCT06373497
Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography
A Early Phase 1 study testing 18-F-NaF Cardiac PET/MRI and and CT Angiogram in people with Oligometastatic Disease, run by Katelyn Atkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oligometastatic Disease
- What is being tested?
- 18-F-NaF Cardiac PET/MRI and and CT Angiogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2025to Oct 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Clinical Trial Recruitment Navigator, 310-423-5842, GroupCancerTrialInformation@cshs.org
Katelyn Atkins, MD, PhD
About this study
Official title: IT2023-08-ATKINS-ATHERO-RT: Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography
The prospective single-arm pilot study, ATHERO-RT: Real-Time Atherosclerosis Activity after Thoracic Radiotherapy using Sodium Fluoride Positron Emission Tomography, will aim to:
- 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
- To detect longitudinal changes in clonal hematopoiesis (CH) genetic architecture following thoracic RT (Radiation Therapy) in patients at high risk of cardiac dysfunction, and
- 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.
- Conditions
- Oligometastatic Disease
- Being tested
- 18-F-NaF Cardiac PET/MRI and, CT Angiogram
- Keywords
- Thoracic Radiotherapy, PET Imaging, MRI Imaging, 18 F-NaF, Clinical Stage II, Clinical Stage III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
CT AngiogramDiagnostic test
All eligible subjects will receive CT Angiogram at baselin
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Fluorine-18-sodium fluoride (18F-NaF) PET/MRI imaging with CT angiography Receives: Diagnostic Test: 18-F-NaF Cardiac PET/MRI and; Diagnostic Test: CT Angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Secondary outcomes (1)
Incidence of MACE
To measure the one-year cumulative incidence of MACE (Major Adverse Cardiovascular Events). The one-year cumulative incidence of MACE will be estimated, adjusting for non cardiac death as a competing risk. For the secondary endpoint, one-year MACE cumulative incidence will be estimated using the Cumulative Incidence Function (CIF), while accounting for non-cardiac death as a competing risk.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start19 Jun 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligometastatic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Katelyn Atkins
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Katelyn Atkins, Cedars-Sinai Medical Center
- Investigators
- Katelyn Atkins, MD, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373497
- Sponsor's protocol ID
- IIT2023-08-ATKINS-ATHERO-RT
- Status last verified
- Aug 2026
- First submitted
- 11 Apr 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IT2023-08-ATKINS-ATHERO-RT: Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography
- ClinicalTrials.gov ID
- NCT06373497
- Acronym / sponsor ID
- IIT2023-08-ATKINS-ATHERO-RT
- Conditions
- Oligometastatic Disease
- Keywords
- Thoracic Radiotherapy, PET Imaging, MRI Imaging, 18 F-NaF, Clinical Stage II, Clinical Stage III
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Katelyn AtkinsUniversity, hospital or other
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prospective single-arm pilot study, ATHERO-RT: Real-Time Atherosclerosis Activity after Thoracic Radiotherapy using Sodium Fluoride Positron Emission Tomography, will aim to:
- 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
- To detect longitudinal changes in clonal hematopoiesis (CH) genetic architecture following thoracic RT (Radiation Therapy) in patients at high risk of cardiac dysfunction, and
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Diagnostic Test: 18-F-NaF Cardiac PET/MRI and, Diagnostic Test: CT AngiogramFluorine-18-sodium fluoride (18F-NaF) PET/MRI imaging with CT angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18-F-NaF Cardiac PET/MRI andAll 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 | Diagnostic test | Single Arm |
| CT AngiogramAll eligible subjects will receive CT Angiogram at baselin | Diagnostic test | Single Arm |
Primary outcome
Feasibility of using F-NaF PET/MRI imaging
Time frame: 6 Months
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.
1 secondary outcome
Incidence of MACE
Time frame: One Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katelyn Atkins, MD, PhD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18-F-NaF Cardiac PET/MRI and and CT Angiogram in people with Oligometastatic Disease, run by Katelyn Atkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Navigator (310-423-5842, GroupCancerTrialInformation@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of using F-NaF PET/MRI imaging (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.