Breast CancerNCT02199366
Study of Cardiac MRI in Patients With Left-Sided Breast Cancer Receiving Radiation Therapy
An observational study of Breast Cancer, run by University of Florida at 1 site in United States.
Trial summary
This is a pilot study to determine if there are changes in heart function following completion of radiation therapy for breast cancer as measured by cardiac magnetic resonance imaging (cardiac MRI) scans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cardiac magnetic resonance (cardiac MRI)
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 31 Mar 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Radiation oncology clinic
Who may be able to join
- Left-sided breast cancer stage I-III.
- Indications for adjuvant regional nodal and breast or chest wall radiation therapy (RT).
- Women and men are allowed.
- Must be at least 18 years old at time of consent.
Who cannot join
- Pregnant and/or breastfeeding women or patients of child-producing potential not willing to use contraception while on study.
- Prior history of cardiovascular disease per physician discretion.
- Stage 0 and IV breast cancer.
- Prior radiation therapy to chest.
- Concurrent trastuzumab per physician discretion.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206
About this study
Official title: Prospective Pilot Study of Early Markers of Radiation-Induced Cardiac Injury in Patients With Left-Sided Breast Cancer Receiving Photon or Proton Therapy
This is a pilot study to determine if there are changes in heart function following completion of radiation therapy for breast cancer as measured by cardiac magnetic resonance imaging (cardiac MRI) scans. Additional purposes of this study are to assess cardiac side effects from radiation treatment, evaluate cardiac MRI changes by radiation technique, and compare quality of life questionnaires.
Read the detailed description
As part of this study, participants will have a cardiac MRI at baseline and a follow-up cardiac MRI within 1 year after completion of standard radiation therapy for left-sided breast cancer. The cardiac MRI scans will be evaluated to determine if there are changes in cardiac function within 1 year after radiation treatment.
Patients will be asked to complete a questionnaire before and after treatment that asks about their health and any symptoms they may be having.
Physical exams and any other standard of care service or treatment will be at the discretion of the treating physician.
- Conditions
- Breast Cancer
- Being tested
- Cardiac magnetic resonance (cardiac MRI)
- Keywords
- Cardiac MRI, Radiation, Proton Radiation, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac magnetic resonance (cardiac MRI)Procedure or surgery
Also called Cardiac MRI, CMR
Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac magnetic resonance (cardiac MRI) | Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy. Receives: Procedure: Cardiac magnetic resonance (cardiac MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with changes in cardiac function.
A change in cardiac function may include shifts from baseline measures of LV mass, strain, ejection fraction, and late gadolinium enhancement.
Measured: 1 year after completion of radiation therapy
Secondary outcomes (2)
Proportion of patients with serious cardiac side effects.
Includes myocardial infarction, valve disorder, congestive heart failure, and angina.
Measured: 1 year after completion of radiation therapy
Mean quality of life score.
Comparison of baseline and post treatment quality of life questionnaires completed by participants.
Measured: 1 year after radiation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startSep 2014
- Primary completion7 Jul 2021
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Ocala Royal Dames
- Responsible party
- Sponsor
- Investigators
- Julie A Bradley, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199366
- Sponsor's protocol ID
- UFPTI 1419-BR02
- Other IDs
- IRB201800163, UFJ 2014-116
- Status last verified
- Jun 2025
- First submitted
- 22 Jul 2014
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study of Early Markers of Radiation-Induced Cardiac Injury in Patients With Left-Sided Breast Cancer Receiving Photon or Proton Therapy
- ClinicalTrials.gov ID
- NCT02199366
- Acronym / sponsor ID
- UFPTI 1419-BR02
- Conditions
- Breast Cancer
- Keywords
- Cardiac MRI, Radiation, Proton Radiation, Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Ocala Royal Dames
- Study start
- Sep 2014 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 24 Jul 2014 (estimated)
- 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.
This is a pilot study to determine if there are changes in heart function following completion of radiation therapy for breast cancer as measured by cardiac magnetic resonance imaging (cardiac MRI) scans. Additional purposes of this study are to assess cardiac side effects from radiation treatment, evaluate cardiac MRI changes by radiation technique, and compare quality of life questionnaires.
Detailed description
As part of this study, participants will have a cardiac MRI at baseline and a follow-up cardiac MRI within 1 year after completion of standard radiation therapy for left-sided breast cancer. The cardiac MRI scans will be evaluated to determine if there are changes in cardiac function within 1 year after radiation treatment.
Patients will be asked to complete a questionnaire before and after treatment that asks about their health and any symptoms they may be having.
Physical exams and any other standard of care service or treatment will be at the discretion of the treating physician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac magnetic resonance (cardiac MRI) | – | Procedure: Cardiac magnetic resonance (cardiac MRI)Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Radiation oncology clinic
Key inclusion criteria (4 listed)
- Left-sided breast cancer stage I-III.
- Indications for adjuvant regional nodal and breast or chest wall radiation therapy (RT).
- Women and men are allowed.
- Must be at least 18 years old at time of consent.
Key exclusion criteria (5 listed)
- Pregnant and/or breastfeeding women or patients of child-producing potential not willing to use contraception while on study.
- Prior history of cardiovascular disease per physician discretion.
- Stage 0 and IV breast cancer.
- Prior radiation therapy to chest.
- Concurrent trastuzumab per physician discretion.
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 (cardiac MRI)Also: Cardiac MRI, CMRParticipants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy. | Procedure or surgery | Cardiac magnetic resonance (cardiac MRI) |
Primary outcome
Proportion of participants with changes in cardiac function.
Time frame: 1 year after completion of radiation therapy
A change in cardiac function may include shifts from baseline measures of LV mass, strain, ejection fraction, and late gadolinium enhancement.
2 secondary outcomes
Proportion of patients with serious cardiac side effects.
Time frame: 1 year after completion of radiation therapy
Mean quality of life score.
Time frame: 1 year after radiation treatment
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 11 Jun 2025.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Julie A Bradley, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Florida 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 4 inclusion and 5 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 11 Jun 2025. 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?
Proportion of participants with changes in cardiac function. (time frame: 1 year after completion of radiation therapy). 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 11 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.