Cardiac MRI Biomarker Testing (GCC 1618)
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | February 1, 2018 |
| End Date: | December 2023 |
| Contact: | Carl Brown, MS |
| Email: | carlbrown@umm.edu |
| Phone: | 410-369-5353 |
Cardiac Magnetic Resonance Imaging and Biomarker Testing for Evaluating Cardiac Injury Resulting From Radiation Therapy in Lung and Breast 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.
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.
The goal is to assess the validity of CMR and biomarker examinations before and after
radiotherapy for lung 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 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.
radiotherapy for lung 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 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.
Inclusion Criteria:
- Breast cancer patients who are undergoing internal mammary lymph node radiation which
is the investigators institutional policy for patients with axillary lymph node
involvement
- Non-surgical Stage III non-small cell lung cancer patients undergoing mediastinal
nodal irradiation with curative intent using concurrent chemotherapy
- 18 years of age or older
- Intensity modulated radiotherapy, 3-D conformal radiotherapy, electron radiotherapy,
and proton radiotherapy will be permitted
- The patient must give protocol-specific consent on an IRB approved consent form prior
to completion of protocol specific testing/procedures
Exclusion Criteria:
- 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
We found this trial at
1
site
Baltimore, Maryland 21201
Principal Investigator: Charles Simone, MD
Phone: 410-369-5353
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