Cardiac MRI Biomarker Testing (GCC 1618)

NCT02688166 | Terminated DMC

• 1 other identifier: HP-00068503
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer; Lung Cancer (Non-Small Cell); Thoracic Cancer; Thymic Cancer; Mesothelioma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

  Baseline and 2 years

• Correlate changes in cardiac function measured by serum biomarkers with radiotherapy dose volume histograms evaluating multiple components of the heart.

  Baseline and 2 years

Study Arms (2)

Breast Cancer

Breast cancer patients who are undergoing internal mammary lymph node radiation

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

Other: Complete Cardiac Magnetic Resonance Imaging (MRI)

Interventions

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

Breast Cancer; Lung Cancer, thymic cancer or mesothelioma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.
• 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.
• years of age or older.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Ummc Msgccc

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Thymus Neoplasms; Mesothelioma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial

Study Officials

• Elizabeth Nichols, MD

  University of Maryland Dept. of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 23, 2016
• Study Start: February 1, 2018
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)