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Imaging Biomarker
PET/MR Imaging for Pulmonary Hypertension
N/A
Recruiting
Led By Patrick Veit-Haibach, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Intention to treat with radio(chemo)therapy with incidental cardiac irradiation of at least 25Gy.
Biopsy or otherwise clinically proven thoracic malignant mass which is intended to be treated with radio(chemo)therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial will help to improve the understanding of the pathophysiology of RT-induced cardiopulmonary dysfunction and to develop new biomarkers for early diagnosis and risk stratification.
Who is the study for?
This trial is for adults over 18 with a diagnosed thoracic cancer intended to be treated with radiotherapy that also affects the heart. They must consent to PET/MR imaging, blood tests, and not be pregnant if of child-bearing age.
What is being tested?
The study is testing how well PET/MR imaging combined with blood analysis can predict heart and lung problems after radiotherapy in patients at risk of developing pulmonary hypertension (high blood pressure in lungs).
What are the potential side effects?
While the trial itself may not have direct side effects, potential risks include discomfort from the PET/MR procedure and reactions related to contrast agents used during imaging.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am planning to undergo radiation therapy that will affect my heart.
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My chest tumor will be treated with radiation or chemo.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change of FDG uptake of heart
Change of FDG uptake of lungs
Change of the heart function
+1 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: One arm / exploratory studyExperimental Treatment1 Intervention
Injection of 18F-FDG.The 18F-FDG cardiac PET-MR scanning visit will take up to 1.5 hours.
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,521 Previous Clinical Trials
503,264 Total Patients Enrolled
Patrick Veit-Haibach, MDPrincipal InvestigatorUniversity Health Network, Toronto
7 Previous Clinical Trials
366 Total Patients Enrolled
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