Radiation TreatmentNCT04486573
Cardiac Effects From Radiation Therapy by MRI
A study testing Cardiac Magnetic Resonance Imaging in people with Radiation Treatment and Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Radiation Treatment, Cancer, Cardiotoxicity
- What is being tested?
- Cardiac Magnetic Resonance Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2020to 14 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Identification of Early Cardiac Injury From Radiation Therapy Using Cardiac Magnetic Resonance Imaging
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.
Read the 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.
- Conditions
- Radiation Treatment, Cancer, Cardiotoxicity
- Being tested
- Cardiac Magnetic Resonance Imaging
- Medical subject headings
- Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic Resonance ImagingDiagnostic test
A cardiac MRI is a painless imaging test that uses radiowaves, magnets, and a computer to create detailed pictures of the heart.
| Study group | Role | What they receive |
|---|---|---|
| CMRI | Other | 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. Receives: Diagnostic Test: Cardiac Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in myocardial strain
Assess for a change in myocardial strain, as measured by CMRI scans performed before and after RT
Measured: 2 years
Secondary outcomes (10)
T1 pre- and post-contrast values
Measured by scans performed before and after RT
Measured: 2 years
Extracellular volume fraction
Measured by scans performed before and after RT
Measured: 2 years
T2 values
Measured by scans performed before and after RT
Measured: 2 years
Late gadolinium enhancement
Measured by scans performed before and after RT
Measured: 2 years
Left ventricular ejection fraction
Measured by scans performed before and after RT
Measured: 2 years
End diastolic volume
Measured by scans performed before and after RT
Measured: 2 years
End systolic volume
Measured by scans performed before and after RT
Measured: 2 years
Left atrial volume
Measured by scans performed before and after RT
Measured: 2 years
Wall thickness
Measured by scans performed before and after RT
Measured: 2 years
Left ventricular mass index
Measured by scans performed before and after RT
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start15 Jul 2020
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation TreatmentStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Milgrom, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486573
- Sponsor's protocol ID
- 20-0537.cc
- Other IDs
- NCI-2020-06349
- Status last verified
- Oct 2024
- First submitted
- 10 Jul 2020
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Early Cardiac Injury From Radiation Therapy Using Cardiac Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04486573
- Acronym / sponsor ID
- 20-0537.cc
- Conditions
- Radiation Treatment, Cancer, Cardiotoxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMRI | Other | Diagnostic Test: Cardiac Magnetic Resonance ImagingClinical 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Magnetic Resonance ImagingA cardiac MRI is a painless imaging test that uses radiowaves, magnets, and a computer to create detailed pictures of the heart. | Diagnostic test | CMRI |
Primary outcome
Change in myocardial strain
Time frame: 2 years
Assess for a change in myocardial strain, as measured by CMRI scans performed before and after RT
10 secondary outcomes
T1 pre- and post-contrast values
Time frame: 2 years
Extracellular volume fraction
Time frame: 2 years
T2 values
Time frame: 2 years
Late gadolinium enhancement
Time frame: 2 years
Left ventricular ejection fraction
Time frame: 2 years
End diastolic volume
Time frame: 2 years
End systolic volume
Time frame: 2 years
Left atrial volume
Time frame: 2 years
Wall thickness
Time frame: 2 years
Left ventricular mass index
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Milgrom, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Magnetic Resonance Imaging in people with Radiation Treatment and Cancer, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in myocardial strain (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.