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NCT Number: NCT05775939

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location status: Recruiting

Location contact

Yevgeniy Vinogradskiy, MD

CONTACT

[email protected]

215-955-3605

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fludeoxyglucose F-18

Other

Given FDG

Other names: 105851-17-0, 18FDG, 2-Deoxy-2-(18F)Fluoro-D-Glucose, 2-F18-Fluoro-2-deoxy-D-glucose, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Positron Emission Tomography

Procedure

Undergo PET-CT

Other names: Medical Imaging, PET, PET SCAN, Positron Emission Tomography Scan, proton magnetic resonance spectroscopic imaging, Positron-Emission Tomography, PT

Computed Tomography

Procedure

Undergo PET-CT

Other names: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography, Computerized Tomography, CT, CT SCAN, tomography

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Change in mean standardized uptake value (SUV) changes in the heart

    Time frame: Up to 30 months after radiotherapy

    Measured by sarcoidosis fludeoxyglucose F-18 (FDG) positron emission tomography (PET)-computed tomography (CT) scans.

Secondary outcomes

  1. Ability of pre- to post-radiotherapy SUV changes in the heart

    Time frame: Up to 30 months after radiotherapy

    Measured by sarcoidosis FDG PET-CT scans.

  2. Overall survival

    Time frame: Up to 30 months after radiotherapy

    Survival

  3. Cardiac toxicity

    Time frame: 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.

  4. Cardiac toxicity judged to be secondary to radiotherapy by cardiologist and radiation oncologist

    Time frame: Up to 30 months after radiotherapy

    Judged to be secondary to radiotherapy by cardiologist and radiation oncologist

  5. Cardiac related death

    Time frame: Up to 30 months after radiotherapy

    Death

Study contacts

Contact information is provided by the study sponsor or research team.

Yevgeniy Vinogradskiy, MD

CONTACT

[email protected]

215-955-3605

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

PET Functional Imaging to Evaluate Cardiac Radiation Damage (EUCLID)

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Mar 20, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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