TerminatedNot applicableNCT02688166
Official study title

Cardiac MRI Biomarker Testing (GCC 1618)

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedComplete Cardiac Magnetic Resonance Imaging (MRI)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Mesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 13, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Maryland, Baltimore

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
University of Maryland, Baltimore
Interventions being studied
Other: Complete Cardiac Magnetic Resonance Imaging (MRI)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
  • 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.
  • 18 years of age or older.
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Ummc MsgcccBaltimore, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 13, 2022. Always confirm current availability with the study team.

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