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

Recruiting
18 years of age
Both
Phase N/A

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Overview

This clinical trial examines positron emission tomography (PET)/computed tomography (CT) in evaluating cardiac radiation damage in patients with lung cancer. As part of the treatment for lung 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.

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.

Eligibility

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
  • Planned radiation treatment course for management of lung cancer * Both standard and hypofractionated 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 details

Lung Carcinoma

NCT05775939

Thomas Jefferson University

27 January 2024

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