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CompletedNCT02769299Updated Jan 9, 2019

Cardiotoxicity of Radiation Therapy (CTRT)

An observational study in Breast Cancer, Lung Cancer and Mediastinal Lymphomas, sponsored by Abramson Cancer Center at Penn Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-09.

Sponsored by Abramson Cancer Center at Penn Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
147
Ages
18 Years and older
Sex
All
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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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Conditions studied

  • Breast Cancer
  • Lung Cancer
  • Mediastinal Lymphomas

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In context

Cardiotoxicity

264 studies on the registry are indexed under Cardiotoxicity; 71 are open to participants now.

This study's enrollment of 147 is above the median of 100 across 125 observational studies indexed under Cardiotoxicity.

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Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

breast cancer, lung cancer, and mediastinal lymphomas

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
147 participants (actual)
Patient registry
No

Interventions

  • RadiationRadiation Therapy

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

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What researchers measure

Primary outcomes

  1. Number of CV injury

    Time frame: 8 months

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Study locations

1 site
  • Abramson Cancer Center of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02769299
Lead sponsor
Abramson Cancer Center at Penn Medicine
Responsible party
Sponsor
First posted
May 11, 2016
Start date
Jun 2, 2015
Primary completion
Nov 26, 2018
Completion
Nov 26, 2018
Last update
Jan 9, 2019

Study contacts

Bonnie Ky, MD
principal investigator · Abramson Cancer Center at Penn Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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