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

Not Applicable

Recruiting

• Conditions: Lung Carcinoma; Esophageal Carcinoma
• Interventions: Other: Fludeoxyglucose F-18; Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Other: Questionnaire Administration

• Registration Number: NCT05775939
• Lead Sponsor: Thomas Jefferson University

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.

Study Timeline

• Study Start: 2023-01-20
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-05
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (sarcoidosis FDG PET-CT)	Fludeoxyglucose F-18	Patients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy.
Diagnostic (sarcoidosis FDG PET-CT)	Questionnaire Administration	Patients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy.
Diagnostic (sarcoidosis FDG PET-CT)	Positron Emission Tomography	Patients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy.
Diagnostic (sarcoidosis FDG PET-CT)	Computed Tomography	Patients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Overall survival	Up to 30 months after radiotherapy	Survival
Ability of pre- to post-radiotherapy SUV changes in the heart	Up to 30 months after radiotherapy	Measured by sarcoidosis FDG PET-CT scans.
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 related death	Up to 30 months after radiotherapy	Death

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States