Esophageal Carcinoma, Lung Carcinoma
Conditions
Brief 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.
Interventions
OTHERFludeoxyglucose F-18
Given FDG
PROCEDUREPositron Emission Tomography
Undergo PET-CT
PROCEDUREComputed Tomography
Undergo PET-CT
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean standardized uptake value (SUV) changes in the heart | Up to 30 months after radiotherapy | Measured by sarcoidosis fludeoxyglucose F-18 (FDG) positron emission tomography (PET)-computed tomography (CT) scans. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ability of pre- to post-radiotherapy SUV changes in the heart | Up to 30 months after radiotherapy | Measured by sarcoidosis FDG PET-CT scans. |
| Overall survival | Up to 30 months after radiotherapy | Survival |
| Cardiac toxicity | Up to 30 months after radiotherapy | Assessed using \>= grade 2 and \>= grade cardiac events using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Cardiac toxicity judged to be secondary to radiotherapy by cardiologist and radiation oncologist | Up to 30 months after radiotherapy | Judged to be secondary to radiotherapy by cardiologist and radiation oncologist |
| Cardiac related death | Up to 30 months after radiotherapy | Death |
Countries
United States
Contacts
CONTACTYevgeniy Vinogradskiy, MD
PRINCIPAL_INVESTIGATORYevgeniy Vinogradskiy
Thomas Jefferson University
Outcome results
None listed