PET/CT Imaging to Evaluate Cardiac Radiation Damage in Patients With Lung or Esophageal Cancer, EUCLID Trial

Thomas Jefferson University

Status: Enrolling

Conditions: Esophageal Carcinoma; Lung Carcinoma

Treatments: Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Procedure: Computed Tomography; Other: Fludeoxyglucose F-18

Study type: Interventional

Funder types: Other

Identifiers

NCT05775939

22D.705

JT 20888 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Diagnostic (sarcoidosis FDG PET-CT)

Experimental group

Description:

Patients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy.

Treatment:

Other: Fludeoxyglucose F-18

Procedure: Computed Tomography

Other: Questionnaire Administration

Procedure: Positron Emission Tomography