- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02769299
Cardiotoxicity of Radiation Therapy (CTRT)
January 8, 2019 updated by: Abramson Cancer Center of the University of Pennsylvania
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
147
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
breast cancer, lung cancer, and mediastinal lymphomas
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of CV injury
Time Frame: 8 months
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 2, 2015
Primary Completion (Actual)
November 26, 2018
Study Completion (Actual)
November 26, 2018
Study Registration Dates
First Submitted
May 9, 2016
First Submitted That Met QC Criteria
May 10, 2016
First Posted (Estimate)
May 11, 2016
Study Record Updates
Last Update Posted (Actual)
January 9, 2019
Last Update Submitted That Met QC Criteria
January 8, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC 04115
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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