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Radiation
Imaging Technique for Atherosclerosis
Phase < 1
Waitlist Available
Led By Katelyn Atkins, MD, PhD
Research Sponsored by Katelyn Atkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Planning to receive standard of care radiotherapy treatment
Must not have
Estimated glomerular filtration rate (eGFR) <45 mL/min/m2 or serum creatinine ≥1.5 mg/dL
Subjects with claustrophobia, problems being in enclosed spaces, or inability to lie supine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to use a new imaging technique to detect heart disease in cancer patients before and after radiation therapy. They will also study genetic changes and immune/metabolic effects in patients at high risk of heart
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not directly related to side effects, the imaging agents used could potentially cause allergic reactions or discomfort at injection sites. The CT Angiogram may involve exposure to contrast materials which can sometimes cause mild side effects like nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am scheduled for standard radiotherapy treatment.
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My cancer is stage II-III or limited stage IV and will be treated with chest radiotherapy that includes my heart.
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I can take care of myself and am up and about more than 50% of my waking hours.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is low, with eGFR <45 or creatinine ≥1.5.
Select...
I am claustrophobic or cannot lie on my back.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of using F-NaF PET/MRI imaging
Secondary study objectives
Incidence of MACE
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment2 Interventions
Fluorine-18-sodium fluoride (18F-NaF) PET/MRI imaging with CT angiography
Find a Location
Who is running the clinical trial?
Katelyn AtkinsLead Sponsor
Katelyn Atkins, MD, PhDPrincipal InvestigatorCedars-Sinai Medical Center
1 Previous Clinical Trials
20 Total Patients Enrolled
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