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Cardiac MRI Biomarker Testing (GCC 1618)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2017 by University of Maryland
Sponsor:
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland
ClinicalTrials.gov Identifier:
NCT02688166
First received: February 12, 2016
Last updated: March 29, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention
Breast Cancer
Lung Cancer (Non-Small Cell)
Thoracic Cancer
Other: Complete Cardiac Magnetic Resonance Imaging (MRI)

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cardiac Magnetic Resonance Imaging and Biomarker Testing for Evaluating Cardiac Injury Resulting From Radiation Therapy in Lung and Breast Cancer: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Breast Cancer
Breast cancer patients who are undergoing internal mammary lymph node radiation
Other: 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
Lung Cancer
Non-surgical Stage III non-small cell lung cancer patients undergoing mediastinal nodal irradiation with curative intent using concurrent chemotherapy
Other: 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

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Investigators hypothesize that 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. 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. 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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02688166

Contacts
Contact: Carl Brown, MS 410-369-5353 carlbrown@umm.edu
Contact: Caitlin Eggleston, BS 410-369-5351 catilineggleston@umm.edu

Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Steven Feigenberg, MD University of Maryland Dept. of Radiation Oncology
  More Information

Responsible Party: Department of Radiation Oncology, Principal Investigator, University of Maryland
ClinicalTrials.gov Identifier: NCT02688166     History of Changes
Other Study ID Numbers: HP-00068503
Study First Received: February 12, 2016
Last Updated: March 29, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2017