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Cardiotoxicity of Radiation Therapy (CTRT)

Cardiotoxicity of Radiation Therapy (CTRT)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02769299
Enrollment
147
Registered
2016-05-11
Start date
2015-06-02
Completion date
2018-11-26
Last updated
2019-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Lung Cancer, Mediastinal Lymphomas

Brief 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.

Interventions

RADIATIONRadiation Therapy

less than 1 Gy with protons to 4-8 Gy with photons

Sponsors

Abramson Cancer Center at Penn Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Number of CV injury8 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026