Cardiotoxicity of Radiation Therapy (CTRT)

Study summary

The overall objective of this proposal is to determine the utility of sensitive imaging and biomarker measures in detecting subclinical cardiotoxicity across a spectrum of radiation doses to the heart. We will focus specifically on patients receiving photon or proton chest radiotherapy. Our broad working hypothesis is that RT induces early, subclinical CV injury, as evidenced by cardiomyocyte inflammation and necrosis, and worsening CV function.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedRadiation Therapy

The study team can explain what participation involves.

Who it may be forBreast Cancer · Lung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 9, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

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?Abramson Cancer Center at Penn Medicine

Study sponsor

Study overview

What this study is about

Purpose: Not specified
Study type: Observational
Phase: Not applicable
Sponsor: Abramson Cancer Center at Penn Medicine
Interventions being studied: Radiation: Radiation Therapy

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How this study is categorized

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

Treatment approach

Radiation therapy→

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

Age 18 years or older.
Patients with left sided breast cancer newly initiating fractionated whole breast/chest wall with regional nodal photon or proton radiation therapy.
Patients with right sided breast cancer with newly initiating fractionated photon or proton radiation therapy with mediastinal nodal proton or photon radiation therapy that will include cardiac dose.
Lung cancer patients treated with definitive intent (greater than or equal to 50 Gy) using fractionated thoracic radiotherapy with proton or photon radiation therapy. Patients receiving concurrent chemotherapy will be allowed.
Patients with mediastinal lymphoma, whose lowest extent of mediastinal disease is at or below the level of the carina, treated with consolidative radiation with definitive intent (greater than or equal to 20 Gy) using fractionated thoracic radiotherapy with proton or photon radiation therapy.
Ability to read and comprehend English.

Reasons someone may not be able to joinExclusion criteria

Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Patients receiving stereotactic body radiotherapy
Patients unable to undergo MR imaging will be excluded from the optional MR, but will not be excluded from the main study.
Life expectancy less than 12 months
Vulnerable patients as noted in 5 below (children, pregnant women, fetuses, neonates, or prisoners)
Patients with estimated glomerular filtration rate of less than 60 ml/min/1.73sq.m will be excluded from the optional MR, but will not be excluded from the main study.
Non-diagnostic echocardiography windows

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

Study sites

U.S. locations

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 9, 2019. Always confirm current availability with the study team.

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