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Radiation
Single Arm for Metastatic Disease
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of using F-NaF PET/MRI imaging
Secondary outcome measures
To measure changes in coronary microcalcification activity (CMA)
To measure changes in standard uptake value (SUV)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment2 Interventions
Fluorine-18-sodium fluoride (18F-NaF) PET/MRI imaging with CT angiography
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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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are prospective patients still eligible to participate in this ongoing medical study?
"As per clinicaltrials.gov, this particular research endeavor is presently not open for new participants. It was initially listed on September 1st, 2024, with the most recent update made on April 15th, 2024. Despite its current inactivity, it's worth noting that there are currently 172 alternative trials actively seeking candidates to take part in their respective studies."
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