Imaging Technique for Atherosclerosis

Recruiting in Palo Alto (17 mi)

Overseen by Katelyn Atkins, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Katelyn Atkins

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

I am 18 years old or older.

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

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

Treatment Details

Interventions

• Thoracic Radiotherapy (Radiation)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cedars Sinai Medical Center Los Angeles, CA

Who Is Running the Clinical Trial?

Katelyn Atkins Lead Sponsor

References