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MRI Monitoring for Heart Effects from Cancer Radiation Therapy
N/A
Waitlist Available
Led By Sarah Milgrom
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Estimated by the treating radiation oncologist at the time of simulation to have a mean left ventricular dose of at least 5 Gy
Will receive RT using computed tomography (CT)-based treatment planning that will involve delivery of dose to the heart
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will study the effects of radiation therapy on the heart by comparing MRI scans of the heart before and after radiation therapy.
Who is the study for?
This trial is for cancer patients aged 18-100 who will undergo radiation therapy with an expected heart dose of at least 5 Gy. They must be able to consent, follow the study plan, and have a reasonable level of physical function (KPS score ≥70 or ECOG status ≤1). Exclusions include prior thorax radiation, non-MRI safe implants, pregnancy, certain heart conditions like severe valve disease or history of heart failure, uncontrolled hypertension, and known allergies to MRI contrast agents.Check my eligibility
What is being tested?
The study tests how standard-of-care radiation therapy affects the heart by using Cardiac Magnetic Resonance Imaging (CMRI) before and after treatment. The main focus is on changes in myocardial strain—a measure of cardiac muscle movement—with secondary attention to other CMRI indicators.See study design
What are the potential side effects?
Since this trial involves diagnostic imaging rather than medication or invasive procedures, side effects are minimal but may include discomfort from lying still during the MRI scan and potential allergic reactions to gadolinium-based contrast agents used in CMRI.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart is expected to receive a radiation dose of at least 5 Gy.
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I will undergo radiation therapy that includes my heart, guided by CT scans.
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I am between 18 and 100 years old.
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I am mostly able to care for myself but may not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in myocardial strain
Secondary outcome measures
End diastolic volume
End systolic volume
Extracellular volume fraction
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CMRIExperimental Treatment1 Intervention
Clinical data will be collected regarding cardiac risk factors, cancer type, and cancer treatment.
CMRI will be performed:
Within 2 weeks before the first fraction of radiation therapy (RT)
Within 1 week of the final fraction of RT (before or after)
Any patient with a pre-RT and post-RT MRI scan will be considered evaluable.
Pre- and post-RT CMRI parameters will be compared.
3D reconstructed CMR images will be co-registered with RT treatment plans to assess for spatial associations.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cardiac Magnetic Resonance Imaging
2020
Completed Phase 2
~250
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,848 Total Patients Enrolled
19 Trials studying Cardiotoxicity
4,977 Patients Enrolled for Cardiotoxicity
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,520 Total Patients Enrolled
Sarah MilgromPrincipal InvestigatorUniversity of Colorado, Denver
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of heart disease.I take more than one blood pressure medication to keep it below 140/90.I am suspected of or have been diagnosed with hemochromatosis.I have a heart valve problem that is more than moderate in severity.My heart is expected to receive a radiation dose of at least 5 Gy.I have severe heart failure.I have a history of irregular heartbeats.Your heart beats fewer than 50 times per minute.I have a history of chronic kidney disease.Your blood pressure is lower than 90mmHg when measured.I am not allergic to gadolinium contrast used in MRI scans.I will undergo radiation therapy that includes my heart, guided by CT scans.I am suspected of or have been diagnosed with amyloidosis.I am between 18 and 100 years old.I have a history of high blood pressure in the lungs.I have had radiation therapy to my chest or breast before.You have a medical device implanted in your chest that cannot be used in an MRI machine.I am mostly able to care for myself but may not be able to do heavy physical work.
Research Study Groups:
This trial has the following groups:- Group 1: CMRI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any geriatric patients being incorporated into this trial?
"To be accepted into this study, potential participants must fall within the 18-100 year demographic."
Answered by AI
Are there any opportunities to join the current clinical trial?
"Per the data provided on clinicaltrials.gov, this trial is in progress and currently recruiting patients. The study first opened its doors to enrollment on July 15th 2020 and was recently updated on November 10th 2022."
Answered by AI
For which patient demographics is this clinical experiment accessible?
"Eligible participants for this trial must have a diagnosis related to cancer, and be between the ages of 18 and 100. The research team is aiming to recruit 10 patients in total."
Answered by AI
What is the total quantity of participants in this experiment?
"Affirmative, the information available through clinicaltrials.gov reveals that this research is actively seeking patients. It was first posted on July 15th 2020 and last updated November 10th 2022, with a goal of recruiting ten participants from one location."
Answered by AI
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