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Cardiac Effects From Radiation Therapy by MRI

Primary Purpose

Radiation Treatment, Cancer, Cardiotoxicity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac Magnetic Resonance Imaging
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Radiation Treatment

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provision to sign and date the consent form.
  2. Stated willingness to comply with all study procedures and be available for the duration of the study.
  3. 18 - 100 years of age
  4. KPS ≥ 70 or ECOG ≥ 1
  5. Will receive RT using computed tomography (CT)-based treatment planning that will involve delivery of dose to the heart
  6. Estimated by the treating radiation oncologist at the time of simulation to have a mean left ventricular dose of at least 5 Gy

Exclusion Criteria:

  1. Previous history of RT to the thorax or breast
  2. Implanted device that is non-MRI compatible or any implanted device in chest
  3. Known gadolinium contrast allergy or other contraindication to CMRI scan. Patients needing sedation or medication for claustrophobia or anxiety will not be excluded from participating.
  4. Found to be pregnant or breast-feeding
  5. Known history of atrial fibrillation or frequent ventricular or atrial premature beats
  6. Known history of chronic kidney disease (such as, but not limited, to a glomerular filtration rate < 60mL/min)
  7. History of coronary artery disease or myocardial disease
  8. History of hypertension, requiring >1 antihypertensive agent to maintain blood pressure <140/90
  9. Known history of valvular stenosis or regurgitation of > moderate severity
  10. Known history of heart failure (defined as baseline New York Heart Association Class III or IV (see Appendix A)
  11. Systolic blood pressure < 90mmGy
  12. Pulse < 50/minute
  13. Known history of pulmonary hypertension or elevated right ventricular systolic pressures.
  14. Suspicion or diagnosis of amyloidosis
  15. Suspicion or diagnosis of hemochromatosis

Sites / Locations

  • University of Colorado HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CMRI

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in myocardial strain
Assess for a change in myocardial strain, as measured by CMRI scans performed before and after RT

Secondary Outcome Measures

T1 pre- and post-contrast values
Measured by scans performed before and after RT
Extracellular volume fraction
Measured by scans performed before and after RT
T2 values
Measured by scans performed before and after RT
Late gadolinium enhancement
Measured by scans performed before and after RT
Left ventricular ejection fraction
Measured by scans performed before and after RT
End diastolic volume
Measured by scans performed before and after RT
End systolic volume
Measured by scans performed before and after RT
Left atrial volume
Measured by scans performed before and after RT
Wall thickness
Measured by scans performed before and after RT
Left ventricular mass index
Measured by scans performed before and after RT

Full Information

First Posted
July 10, 2020
Last Updated
April 21, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT04486573
Brief Title
Cardiac Effects From Radiation Therapy by MRI
Official Title
Identification of Early Cardiac Injury From Radiation Therapy Using Cardiac Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
March 27, 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators will identify 10 patients in the department of radiation oncology who will receive standard of-care radiation therapy, and the treating radiation oncologist anticipates a mean left ventricular dose of at least 5 Gy. Patients will be evaluated by CMRI before and within one week of the completion of RT. We will compare the pre- and post-RT CMRI scans to identify changes related to radiation exposure. Our primary endpoint will be changes in myocardial strain. Secondary endpoints will include other CMRI parameters.
Detailed Description
Cardiac toxicity is a significant cause of morbidity and mortality in cancer survivors after radiation therapy (RT) to the chest. Typically, cardiotoxicity is identified years after radiation exposure. Emerging clinical data show that subclinical injury can be identified immediately after treatment. Early identification of subclinical injury may enable intervention to reduce the risk of progression to clinically significant toxicity. The investigators hypothesize that cardiac magnetic resonance imaging (CMRI) will detect early cardiac injury after RT and that imaging changes will be associated regionally with cardiac radiation dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Treatment, Cancer, Cardiotoxicity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CMRI
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiac Magnetic Resonance Imaging
Intervention Description
A cardiac MRI is a painless imaging test that uses radiowaves, magnets, and a computer to create detailed pictures of the heart.
Primary Outcome Measure Information:
Title
Change in myocardial strain
Description
Assess for a change in myocardial strain, as measured by CMRI scans performed before and after RT
Time Frame
2 years
Secondary Outcome Measure Information:
Title
T1 pre- and post-contrast values
Description
Measured by scans performed before and after RT
Time Frame
2 years
Title
Extracellular volume fraction
Description
Measured by scans performed before and after RT
Time Frame
2 years
Title
T2 values
Description
Measured by scans performed before and after RT
Time Frame
2 years
Title
Late gadolinium enhancement
Description
Measured by scans performed before and after RT
Time Frame
2 years
Title
Left ventricular ejection fraction
Description
Measured by scans performed before and after RT
Time Frame
2 years
Title
End diastolic volume
Description
Measured by scans performed before and after RT
Time Frame
2 years
Title
End systolic volume
Description
Measured by scans performed before and after RT
Time Frame
2 years
Title
Left atrial volume
Description
Measured by scans performed before and after RT
Time Frame
2 years
Title
Wall thickness
Description
Measured by scans performed before and after RT
Time Frame
2 years
Title
Left ventricular mass index
Description
Measured by scans performed before and after RT
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision to sign and date the consent form. Stated willingness to comply with all study procedures and be available for the duration of the study. 18 - 100 years of age KPS ≥ 70 or ECOG ≥ 1 Will receive RT using computed tomography (CT)-based treatment planning that will involve delivery of dose to the heart Estimated by the treating radiation oncologist at the time of simulation to have a mean left ventricular dose of at least 5 Gy Exclusion Criteria: Previous history of RT to the thorax or breast Implanted device that is non-MRI compatible or any implanted device in chest Known gadolinium contrast allergy or other contraindication to CMRI scan. Patients needing sedation or medication for claustrophobia or anxiety will not be excluded from participating. Found to be pregnant or breast-feeding Known history of atrial fibrillation or frequent ventricular or atrial premature beats Known history of chronic kidney disease (such as, but not limited, to a glomerular filtration rate < 60mL/min) History of coronary artery disease or myocardial disease History of hypertension, requiring >1 antihypertensive agent to maintain blood pressure <140/90 Known history of valvular stenosis or regurgitation of > moderate severity Known history of heart failure (defined as baseline New York Heart Association Class III or IV (see Appendix A) Systolic blood pressure < 90mmGy Pulse < 50/minute Known history of pulmonary hypertension or elevated right ventricular systolic pressures. Suspicion or diagnosis of amyloidosis Suspicion or diagnosis of hemochromatosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chelsea Schaefer
Phone
17208480608
Email
chelsea.schaefer@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Milgrom
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Milgrom
Email
sarah.milgrom@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Sarah Milgrom

12. IPD Sharing Statement

Plan to Share IPD
No

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Cardiac Effects From Radiation Therapy by MRI

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