RecruitingRecruiting
PET/CT Imaging to Evaluate Cardiac Radiation Damage in Patients With Lung or Esophageal Cancer, EUCLID Trial
NCT05775939 · Thomas Jefferson University
In plain English
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Official title
PET Functional Imaging to Evaluate Cardiac Radiation Damage (EUCLID)
About this study
PRIMARY OBJECTIVE:
I. To characterize radiation-related functional imaging changes in the heart using sarcoidosis fludeoxyglucose F-18 (FDG) PET-CT imaging.
SECONDARY OBJECTIVES:
I. 1. To evaluate the ability of imaging changes in the heart to predict for overall survival (OS).
II. To evaluate the ability of imaging changes in the heart to predict for cardiac toxicity.
III. To evaluate the ability of imaging changes in the heart to predict for cardiac related death.
EXPLORATORY OBJECTIVES:
I. To evaluate radiation treatment planning strategies to reduce risk of cardiotoxicity.
II. To determine the correlation between sarcoidosis FDG PET-CT scans and oncologic FDG PET-CT scans.
OUTLINE:
Patients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy.
After completion of study treatment, patients are followed up at 12 and 24 months.
Eligibility criteria
Inclusion Criteria:
* Provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* Male or female, aged \>= 18
* Life expectancy \>= 3 months as assessed by Radiation Oncologist
* Mean heart dose estimated by Radiation Oncologist to be \>= 5 Gy (physics dose or biologically equivalent dose)
* Pathologically proven (either histologic or cytologic) proven lung cancer or esophageal cancer
* Planned radiation treatment course for management of lung or esophageal cancer \* Both standard and hypofractionation schedules are permitted
Exclusion Criteria:
* Contraindication for FDG PET-CT scans as assessed by the radiation oncologist or nuclear medicine radiologist
* Palliative radiation doses defined as 20 Gy in 5 fractions
Study design
Enrollment target: 20 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-01-20
Estimated completion: 2028-07-01
Last updated: 2026-02-10
Interventions
Other: Fludeoxyglucose F-18Procedure: Positron Emission TomographyProcedure: Computed TomographyOther: Questionnaire Administration
Primary outcomes
- • Change in mean standardized uptake value (SUV) changes in the heart (Up to 30 months after radiotherapy)
Sponsor
Thomas Jefferson University · other
Contacts & investigators
ContactYevgeniy Vinogradskiy, MD · contact · yevgeniy.vinogradskiy@jefferson.edu · 215-955-3605
InvestigatorYevgeniy Vinogradskiy · principal_investigator, Thomas Jefferson University
All locations (1)
Thomas Jefferson University HospitalRecruiting
Philadelphia, Pennsylvania, United States