Cardiotoxicity of Radiation Therapy (CTRT)

Completed

Conditions studied: Breast Cancer, Lung Cancer, Mediastinal Lymphomas

In brief

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.

Key facts

Study ID

NCT02769299

Run by

Abramson Cancer Center at Penn Medicine

People needed

147

Starts

2015-06-02

Expected to finish

2018-11-26

Last updated by the study team

2019-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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