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NCT05775939 | RECRUITING | Lung Carcinoma

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

Condition or disease

Lung Carcinoma

Esophageal Carcinoma

Intervention/treatment

Fludeoxyglucose F-18

Positron Emission Tomography

Computed Tomography

Questionnaire Administration

Phase

NA

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
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : PET Functional Imaging to Evaluate Cardiac Radiation Damage (EUCLID)
Actual Study Start Date : 2023-01-20
Estimated Primary Completion Date : 2026-01-01
Estimated Study Completion Date : 2026-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
PET/CT Imaging to Evaluate Cardiac Radiation Damage in Patients With Lung or Esophageal Cancer, EUCLID Trial

Location Details

NCT05775939

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How to Participate

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Locations

RECRUITING

United States, Pennsylvania

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107