Imaging Technique for Atherosclerosis

Overseen By Clinical Trial Navigator

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Katelyn Atkins

Disqualifiers: Low eGFR, Allergy to contrast, Claustrophobia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method to detect heart changes after cancer treatment. Using a special scan called 18F-NaF PET/MRI, researchers aim to observe how thoracic radiotherapy (a type of cancer radiation therapy) affects heart health. The trial seeks participants with Stage II-III or certain advanced cancers who are at risk for heart issues due to radiation treatment. Participants from Cedars-Sinai Medical Center will undergo scans and blood tests to monitor heart changes over time. As an Early Phase 1 trial, this research focuses on understanding the imaging technique's effectiveness in people, offering participants a chance to contribute to groundbreaking advancements in heart health monitoring.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this imaging technique is safe?

Research has shown that fluorine-18-sodium fluoride (18F-NaF) PET/MRI imaging offers a new method to detect early signs of atherosclerosis, a condition where arteries harden due to plaque build-up. This imaging technique is valuable because it reveals arterial changes linked to heart disease risk. Several studies have investigated its use for various heart-related issues, demonstrating its effectiveness in identifying problem areas in blood vessels.

Although 18F-NaF PET/MRI is new and still under investigation, it has been linked to the detection of early, tiny calcium deposits in arteries. This capability can aid doctors in understanding and managing heart disease risk before it becomes serious. So far, no major safety concerns have been clearly evidenced with this imaging method. However, as this trial is in its earliest phase, it primarily focuses on exploring safety in humans. The safety profile is still being established, and any potential risks are under close observation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses an innovative imaging approach to better understand atherosclerosis. Unlike standard imaging techniques, this study employs Fluorine-18-sodium fluoride (18F-NaF) combined with PET/MRI and CT angiography. This combination allows for a more detailed view of calcium deposits and plaque activity in the arteries, which can help in identifying high-risk areas that might lead to heart attacks. This method could significantly enhance the precision of diagnosing and managing atherosclerosis compared to traditional imaging, which often focuses only on the presence of blockages.

What evidence suggests that this imaging technique is effective for detecting atherosclerosis?

Research has shown that a special type of scan called fluorine-18-sodium fluoride (18F-NaF) PET can effectively detect atherosclerosis, a condition where fats, cholesterol, and other substances accumulate in artery walls. Studies have found that 18F-NaF PET can identify active hardening in these buildups, early signs of heart disease. It also helps predict the risk of heart attacks in individuals with heart artery problems. This trial will use 18F-NaF PET/MRI imaging with CT angiography to further explore its effectiveness. These findings suggest that 18F-NaF PET imaging is a powerful tool for detecting early signs of artery disease, potentially helping to prevent serious heart issues. ^{1 4 6 7 8}

Who Is on the Research Team?

Katelyn Atkins, MD, PhD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with Stage II-III or oligo-metastatic stage IV cancer, at high risk of heart issues from radiation therapy (RT). They must be receiving RT where the heart is exposed to ≥30 Gy. Only 10 people will be chosen from Cedars-Sinai Medical Center.

Inclusion Criteria

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

I am scheduled for standard radiotherapy treatment.

Exclusion Criteria

Allergy to animal dander or animal-instigated asthma

Subjects that are pregnant or breastfeeding

Patients with a known or previous allergy to iodinated contrast, gadolinium contrast, and/or 18F-NaF tracer

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Baseline 18F-NaF PET/MRI imaging to detect real-time atherosclerosis activity at the time of cancer diagnosis

1 week

1 visit (in-person)

Radiation Therapy

Participants receive thoracic radiation therapy with monitoring of cardiac exposure

6-8 weeks

Post-Radiation Imaging

18F-NaF PET/MRI imaging to detect atherosclerosis activity after cardiac radiation exposure

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood collection and assessment of MACE incidence

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Thoracic Radiotherapy

Trial Overview The study tests a new imaging technique using PET/MRI scans with Sodium Fluoride to track atherosclerosis activity in real-time during and after RT. It also examines changes in genetic markers and immune/metabolic responses post-RT.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 2 Interventions

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

Thoracic Radiotherapy is already approved in China, European Union for the following indications:

Approved in China as HANSIZHUANG for:

• Microsatellite instability-high solid tumors
• Squamous non-small cell lung cancer
• Extensive-stage small cell lung cancer
• Esophageal squamous cell carcinoma

Approved in European Union as Hetronifly for:

• Extensive-stage small cell lung cancer

Who Is Running the Clinical Trial?

Katelyn Atkins

Lead Sponsor

Trials

1

Recruited

10+

Published Research Related to This Trial

In a study of 22 patients with esophageal cancer, radiation doses of 20 Gy or higher significantly reduced myocardial blood flow (MBF) in the heart's left ventricle three months after radiation therapy, indicating potential cardiac risks associated with higher radiation exposure.

The findings suggest that monitoring and managing radiation doses during treatment could be crucial in preventing late adverse cardiac events in patients undergoing radiation therapy for thoracic malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results of reduced myocardial blood flow in the subacute phase after radiation therapy for thoracic esophageal cancer: A quantitative analysis with stress dynamic myocardial computed tomography perfusion imaging. Takada, A., Ichikawa, Y., Nakamura, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7188711/

Atherosclerosis imaging with 18F-sodium fluoride PET NaF-PET is a new approach to detect and quantify microcalcification in early-stage atherosclerosis. NaF uptake correlates with cardiovascular risk factors.

2. ahajournals.org ahajournals.org/doi/10.1161/ATVBAHA.121.316075

Analysis of 18 F-Sodium Fluoride Positron Emission ... 18 F-sodium fluoride ( 18 F-NaF) positron emission tomography (PET) imaging is thought to visualize active atherosclerotic plaque calcification.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0735109720350932

Coronary 18F-Sodium Fluoride Uptake Predicts Outcomes ... In patients with established coronary artery disease, 18 F-NaF PET provides powerful independent prediction of fatal or nonfatal myocardial infarction.

4. jacc.org jacc.org/doi/10.1016/j.jacc.2020.04.047

18F-Sodium Fluoride PET Imaging Passes an Important ... 18 F-sodium fluoride uptake identified the culprit plaque in patients with recent myocardial infarction and was present in plaques with multiple adverse ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7590213/

Atherosclerosis Imaging with 18F-Sodium Fluoride PET NaF uptake is considered a marker of early stage atherosclerosis, is age-dependent, and consistently associated with cardiovascular risk.

6. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.212283

18 F-NaF PET/MRI for Detection of Carotid Atheroma in ... Fluorine 18–labeled sodium fluoride PET/MRI characteristics were associated with the culprit atherosclerotic plaques in the carotid circulation ...

7. ahajournals.org ahajournals.org/doi/10.1161/ATVBAHA.120.313785

18F-Sodium Fluoride (18F-NaF) for Imaging ... 18 F-NaF PET has been used to investigate a wide range of valvular conditions, including aortic stenosis, mitral annular calcification, and bioprosthetic valve ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1071358123018706

Coronary artery 18F-NaF PET analysis with the use of an ... 18F-Sodium Fluoride Positron Emission Tomography (18F-NaF PET) is a novel molecular imaging modality with promise for use as a risk stratification tool in ...