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Trial Title:
PET/CT Imaging to Evaluate Cardiac Radiation Damage in Patients With Lung or Esophageal Cancer, EUCLID Trial
NCT ID:
NCT05775939
Condition:
Lung Carcinoma
Esophageal Carcinoma
Conditions: Official terms:
Carcinoma
Esophageal Neoplasms
Deoxyglucose
Fluorodeoxyglucose F18
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Fludeoxyglucose F-18
Description:
Given FDG
Arm group label:
Diagnostic (sarcoidosis FDG PET-CT)
Other name:
105851-17-0
Other name:
18FDG
Other name:
2-Deoxy-2-(18F)Fluoro-D-Glucose
Other name:
2-F18-Fluoro-2-deoxy-D-glucose
Other name:
FDG
Other name:
Fludeoxyglucose (18F)
Other name:
fludeoxyglucose F 18
Other name:
Fludeoxyglucose F18
Other name:
Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
Other name:
Fluorodeoxyglucose F18
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET-CT
Arm group label:
Diagnostic (sarcoidosis FDG PET-CT)
Other name:
Medical Imaging
Other name:
PET
Other name:
PET SCAN
Other name:
Positron Emission Tomography Scan
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
Positron-Emission Tomography
Other name:
PT
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PET-CT
Arm group label:
Diagnostic (sarcoidosis FDG PET-CT)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
computerized axial tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT SCAN
Other name:
tomography
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Diagnostic (sarcoidosis FDG PET-CT)
Summary:
This clinical trial examines positron emission tomography (PET)/computed tomography (CT)
in evaluating cardiac radiation damage in patients with lung or esophageal cancer. As
part of the treatment for lung or esophageal cancer, patients will undergo radiation
therapy. Sometimes, during this treatment, the heart is also subjected to some radiation
which could affect its function, either increasing or decreasing the function. It is not
known the consequences of this change nor is it known if doctors can detect the changes
associated with the radiation. Sarcoidosis FDG positron emission tomography
(PET)-computed tomography (CT) scans are a common way to image cardiac inflammation and
myocardial viability. This study may help doctors image the heart before, during and
after radiotherapy to monitor any changes.
Detailed description:
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Thomas Jefferson University Hospital
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yevgeniy Vinogradskiy, MD
Phone:
215-955-3605
Email:
yevgeniy.vinogradskiy@jefferson.edu
Start date:
January 20, 2023
Completion date:
January 1, 2026
Lead sponsor:
Agency:
Thomas Jefferson University
Agency class:
Other
Source:
Thomas Jefferson University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05775939
