Breast CancerNCT02688166
Cardiac MRI Biomarker Testing (GCC 1618)
An observational study of Breast Cancer and Lung Cancer (Non-Small Cell), run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This research study can help understand how cardiac changes may occur with radiation therapy to the heart based off measurements obtained through biomarkers and cardiac imaging. Researchers plan to perform cardiac imaging and biomarkers for any cardiac injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer (Non-Small Cell), Thoracic Cancer
- What is being tested?
- Complete Cardiac Magnetic Resonance Imaging (MRI)
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 9 Sep 2022
- 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: Investigators hypothesize that CMR and biomarker examinations before and after radiotherapy for lung cancer, thymic cancer or mesothelioma and breast cancers will demonstrate evidence of cardiac strain and dysfunction proportional to the extent of cardiac exposure during the course of radiation. Investigators intent to conduct a pilot study of 10 patients receiving moderate doses of radiation exposure to heart (5 lung cancer, thymic cancer, mesothelioma and 5 breast cancer patients) when treated by our current institutional standards with the idea that this could lead to a grant if early signs of cardiac injury can be measured. These patients' treatment plans would include contours to measure dose received by multiple structures within the heart (coronary vessels and all cardiac chambers) as well as the heart/pericardium itself.
Who may be able to join
- Breast cancer patients who are undergoing internal mammary lymph node radiation which is the investigators institutional policy for patients with axillary lymph node involvement
- Clinical AJCC (AJCC, 7th ed.) II, IIIA or IIIB with non-operable disease or those who refuse surgery who are recommended concurrent chemoradiation. Patients who present with N2 or N3 disease and an undetectable NSCLC primary tumor are eligible.
- Any lung cancer, thymic cancer or mesothelioma patient getting either chemoradiation or radiation alone wherein heart gets radiation exposure
- Patients who have received systemic treatment (up to 4 cycles of induction chemotherapy, or up to 6 months of targeted therapy) and are rendered candidate for concurrent chemoradiation are also eligible
- Patients with recurrent disease overlapping or in close proximity to heart getting hypofractionated or conventionally fractionated proton therapy alone.
- Intensity modulated radiotherapy, 3-D conformal radiotherapy, electron radiotherapy, and proton radiotherapy will be permitted.
Show all 9Show fewer
- Patients who develop local or nodal recurrence after surgery and rendered candidate for definitive concurrent chemoradiation are also eligible.
- The patient must give protocol-specific consent on an IRB approved consent form prior to completion of protocol specific testing/procedures.
- 18 years of age or older.
Who cannot join
- Pregnant/breast feeding patients or those not willing to undertake contraception if of child-producing potential while on study
- Patients with Stage IV disease
- Patients with contraindications to MRI examination (e.g. gadolinium allergies/reactions, metallic implants, incompatible implanted electronic/cardiac devices, over scanner weight tolerance etc.)
- Patients with hepatorenal syndrome
- Patients with Chronic Kidney Disease defined as eGFR <30 ml/min
- Patients unable to lie supine for 30 minutes for MRI examination
- Patients having undergone prior radiation therapy to the chest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac Magnetic Resonance Imaging and Biomarker Testing for Evaluating Cardiac Injury Resulting From Radiation Therapy in Cancer: A Pilot Study
This research study can help understand how cardiac changes may occur with radiation therapy to the heart based off measurements obtained through biomarkers and cardiac imaging.
Researchers plan to perform cardiac imaging and biomarkers for any cardiac injury. Cardiac magnetic resonance imaging (CMR) provides the ability to quantitatively measure cardiac function and injury. The cardiac biomarkers that will be tested are effective in the diagnosis, risk-stratification, and monitoring of heart failure.
Read the detailed description
The goal is to assess the validity of CMR and biomarker examinations before and after radiotherapy for lung cancer, thymic cancer, mesothelioma and breast cancers will demonstrate evidence of cardiac strain and dysfunction proportional to the extent of cardiac exposure during the course of radiation. The investigators intention is to conduct a pilot study of 10 patients receiving moderate doses of radiation exposure to the heart (5 lung cancer patients, , thymic cancer or mesothelioma and 5 breast cancer patients) when treated by our current institutional standards with the idea that this could lead to a grant if early signs of cardiac injury can be measured. These patients' treatment plans would include contours to measure dose received by multiple structures within the heart (coronary vessels and all cardiac chambers) as well as the heart/pericardium itself. The investigators would obtain biomarkers by bloodwork before, during, and after radiotherapy for correlation with clinical outcomes and Cardiac MRIs obtained prior to and 1 year after completion of radiotherapy. Investigators would obtain biomarkers by bloodwork before, during, and after radiotherapy for correlation with clinical outcomes and Cardiac MRs obtained prior to and 1 year after completion of radiotherapy.
- Being tested
- Complete Cardiac Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Thymus Neoplasms, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Cardiac Magnetic Resonance Imaging (MRI)Other
Complete Cardiac Magnetic Resonance Imaging (MRI) prior to treatment and then at approximately 1 year after completion of radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer | Breast cancer patients who are undergoing internal mammary lymph node radiation Receives: Other: Complete Cardiac Magnetic Resonance Imaging (MRI) | |
| Lung Cancer, thymic cancer or mesothelioma | Non-surgical Stage III non-small cell lung cancer patients undergoing mediastinal nodal irradiation with curative intent using concurrent chemotherapy
Any lung cancer, thymic cancer or mesothelioma patient getting either chemoradiation or radiation alone wherein heart gets radiation exposure Receives: Other: Complete Cardiac Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate for evidence of changes in cardiac function measured by cardiac MRI prior to and following external beam radiotherapy who are receiving moderate doses of radiation to the heart.
Measured: Baseline and 2 years
Evidence of changes in cardiac function as measured by serum biomarkers following external beam radiotherapy who are receiving moderate doses of radiation to the heart.
Measured: Baseline and 2 years
Secondary outcomes (2)
Correlate changes in cardiac function measured by cardiac MRI with radiotherapy dose volume histograms evaluating multiple components of the heart.
Measured: Baseline and 2 years
Correlate changes in cardiac function measured by serum biomarkers with radiotherapy dose volume histograms evaluating multiple components of the heart.
Measured: Baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start1 Feb 2018
- Primary completion9 Sep 2022
- Study completion9 Sep 2022
Why it stopped: Unable to meet accrual goal
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Department of Radiation Oncology, University of Maryland, Baltimore
- Investigators
- Elizabeth Nichols, MD, Principal investigator, University of Maryland Dept. of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688166
- Sponsor's protocol ID
- HP-00068503
- Status last verified
- Oct 2022
- First submitted
- 12 Feb 2016
- Last updated
- 13 Oct 2022
- 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 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Magnetic Resonance Imaging and Biomarker Testing for Evaluating Cardiac Injury Resulting From Radiation Therapy in Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT02688166
- Acronym / sponsor ID
- HP-00068503
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to meet accrual goal
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 23 Feb 2016 (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 research study can help understand how cardiac changes may occur with radiation therapy to the heart based off measurements obtained through biomarkers and cardiac imaging.
Researchers plan to perform cardiac imaging and biomarkers for any cardiac injury. Cardiac magnetic resonance imaging (CMR) provides the ability to quantitatively measure cardiac function and injury. The cardiac biomarkers that will be tested are effective in the diagnosis, risk-stratification, and monitoring of heart failure.
Detailed description
The goal is to assess the validity of CMR and biomarker examinations before and after radiotherapy for lung cancer, thymic cancer, mesothelioma and breast cancers will demonstrate evidence of cardiac strain and dysfunction proportional to the extent of cardiac exposure during the course of radiation. The investigators intention is to conduct a pilot study of 10 patients receiving moderate doses of radiation exposure to the heart (5 lung cancer patients, , thymic cancer or mesothelioma and 5 breast cancer patients) when treated by our current institutional standards with the idea that this could lead to a grant if early signs of cardiac injury can be measured. These patients' treatment plans would include contours to measure dose received by multiple structures within the heart (coronary vessels and all cardiac chambers) as well as the heart/pericardium itself. The investigators would obtain biomarkers by bloodwork before, during, and after radiotherapy for correlation with clinical outcomes and Cardiac MRIs obtained prior to and 1 year after completion of radiotherapy. Investigators would obtain biomarkers by bloodwork before, during, and after radiotherapy for correlation with clinical outcomes and Cardiac MRs obtained prior to and 1 year after completion of radiotherapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer | – | Other: Complete Cardiac Magnetic Resonance Imaging (MRI)Breast cancer patients who are undergoing internal mammary lymph node radiation |
| Lung Cancer, thymic cancer or mesothelioma | – | Other: Complete Cardiac Magnetic Resonance Imaging (MRI)Non-surgical Stage III non-small cell lung cancer patients undergoing mediastinal nodal irradiation with curative intent using concurrent chemotherapy Any lung cancer, thymic cancer or mesothelioma patient getting either chemoradiation or radiation alone wherein heart gets radiation exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators hypothesize that CMR and biomarker examinations before and after radiotherapy for lung cancer, thymic cancer or mesothelioma and breast cancers will demonstrate evidence of cardiac strain and dysfunction proportional to the extent of cardiac exposure during the course of radiation. Investigators intent to conduct a pilot study of 10 patients receiving moderate doses of radiation exposure to heart (5 lung cancer, thymic cancer, mesothelioma and 5 breast cancer patients) when treated by our current institutional standards with the idea that this could lead to a grant if early signs of cardiac injury can be measured. These patients' treatment plans would include contours to measure dose received by multiple structures within the heart (coronary vessels and all cardiac chambers) as well as the heart/pericardium itself.
Key inclusion criteria (9 listed)
- Breast cancer patients who are undergoing internal mammary lymph node radiation which is the investigators institutional policy for patients with axillary lymph node involvement
- Clinical AJCC (AJCC, 7th ed.) II, IIIA or IIIB with non-operable disease or those who refuse surgery who are recommended concurrent chemoradiation. Patients who present with N2 or N3 disease and an undetectable NSCLC primary tumor are eligible.
- Any lung cancer, thymic cancer or mesothelioma patient getting either chemoradiation or radiation alone wherein heart gets radiation exposure
- Patients who have received systemic treatment (up to 4 cycles of induction chemotherapy, or up to 6 months of targeted therapy) and are rendered candidate for concurrent chemoradiation are also eligible
- Patients with recurrent disease overlapping or in close proximity to heart getting hypofractionated or conventionally fractionated proton therapy alone.
Key exclusion criteria (7 listed)
- Pregnant/breast feeding patients or those not willing to undertake contraception if of child-producing potential while on study
- Patients with Stage IV disease
- Patients with contraindications to MRI examination (e.g. gadolinium allergies/reactions, metallic implants, incompatible implanted electronic/cardiac devices, over scanner weight tolerance etc.)
- Patients with hepatorenal syndrome
- Patients with Chronic Kidney Disease defined as eGFR <30 ml/min
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 |
|---|---|---|
| Complete Cardiac Magnetic Resonance Imaging (MRI)Complete Cardiac Magnetic Resonance Imaging (MRI) prior to treatment and then at approximately 1 year after completion of radiation therapy | Other | Breast Cancer, Lung Cancer, thymic cancer or mesothelioma |
Primary outcome
Evaluate for evidence of changes in cardiac function measured by cardiac MRI prior to and following external beam radiotherapy who are receiving moderate doses of radiation to the heart.
Time frame: Baseline and 2 years
Evidence of changes in cardiac function as measured by serum biomarkers following external beam radiotherapy who are receiving moderate doses of radiation to the heart.
Time frame: Baseline and 2 years
2 secondary outcomes
Correlate changes in cardiac function measured by cardiac MRI with radiotherapy dose volume histograms evaluating multiple components of the heart.
Time frame: Baseline and 2 years
Correlate changes in cardiac function measured by serum biomarkers with radiotherapy dose volume histograms evaluating multiple components of the heart.
Time frame: Baseline and 2 years
Results and safety
The study was stopped early (reason given: Unable to meet accrual goal). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- 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.
Elizabeth Nichols, MD principal investigator
University of Maryland Dept. of Radiation Oncology
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 and Lung Cancer (Non-Small Cell), run by University of Maryland, Baltimore 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 9 inclusion and 7 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: stopped early, as of the sponsor's last update on 13 Oct 2022. 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 was stopped early (reason given: Unable to meet accrual goal). Results are not available in the source record.
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?
Evaluate for evidence of changes in cardiac function measured by cardiac MRI prior to and following external beam radiotherapy who are receiving moderate doses of radiation to the heart. (time frame: Baseline and 2 years). The study lists 2 primary outcomes in all. 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 13 Oct 2022.