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

PET Functional Imaging to Evaluate Cardiac Radiation Damage (EUCLID)

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Carcinoma; Esophageal Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Fludeoxyglucose F-18; Procedure: Positron Emission Tomography; Procedure: Computed Tomography

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yevgeniy Vinogradskiy, MD; Phone Number: 215-955-3605; Email: yevgeniy.vinogradskiy@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital
      • Contact: Yevgeniy Vinogradskiy, MD; Phone Number: 215-955-3605; Email: yevgeniy.vinogradskiy@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (sarcoidosis FDG PET-CT); Patients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy.

Other: Questionnaire Administration; Ancillary studies; Other: Fludeoxyglucose F-18; Given FDG; Other Names: 18FDG; FDG; fludeoxyglucose F 18; Fludeoxyglucose (18F); Fludeoxyglucose F18; Fluorine-18 2-Fluoro-2-deoxy-D-Glucose; Fluorodeoxyglucose F18; 2-Deoxy-2-(18F)Fluoro-D-Glucose; 2-F18-Fluoro-2-deoxy-D-glucose; 105851-17-0; Procedure: Positron Emission Tomography; Undergo PET-CT; Other Names: PET; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging; PT; PET SCAN; Medical Imaging; Procedure: Computed Tomography; Undergo PET-CT; Other Names: CT; CAT; CAT Scan; Computed Axial Tomography; Computerized Tomography; tomography; CT SCAN; computerized axial tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean standardized uptake value (SUV) changes in the heart	Measured by sarcoidosis fludeoxyglucose F-18 (FDG) positron emission tomography (PET)-computed tomography (CT) scans.	Up to 30 months after radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability of pre- to post-radiotherapy SUV changes in the heart	Measured by sarcoidosis FDG PET-CT scans.	Up to 30 months after radiotherapy
Overall survival	Survival	Up to 30 months after radiotherapy
Cardiac toxicity	Assessed using >= grade 2 and >= grade cardiac events using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	Up to 30 months after radiotherapy
Cardiac toxicity judged to be secondary to radiotherapy by cardiologist and radiation oncologist	Judged to be secondary to radiotherapy by cardiologist and radiation oncologist	Up to 30 months after radiotherapy
Cardiac related death	Death	Up to 30 months after radiotherapy

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Yevgeniy Vinogradskiy, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Carcinoma; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Radiopharmaceuticals; Fluorodeoxyglucose F18; Deoxyglucose
• Other Study ID Numbers: 22D.705

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No