Clinical trial NCT05775939: PET/CT Imaging to Evaluate Cardiac Radiation Damage in Patients With Lung or Esophageal Cancer, EUCLID Trial
Official title: PET Functional Imaging to Evaluate Cardiac Radiation Damage (EUCLID)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Carcinoma
Esophageal Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Change in mean standardized uptake value (SUV) changes in the heart
timeFrame: Up to 30 months after radiotherapy
Secondary outcomes:
measure: Ability of pre- to post-radiotherapy SUV changes in the heart
timeFrame: Up to 30 months after radiotherapy
measure: Overall survival
timeFrame: Up to 30 months after radiotherapy
measure: Cardiac toxicity
timeFrame: Up to 30 months after radiotherapy
measure: Cardiac toxicity judged to be secondary to radiotherapy by cardiologist and radiation oncologist
timeFrame: Up to 30 months after radiotherapy
measure: Cardiac related death
timeFrame: Up to 30 months after radiotherapy
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Yevgeniy Vinogradskiy
role: PRINCIPAL_INVESTIGATOR
References: