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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-20

Study Completion Date

2026-01-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Lung Carcinoma Esophageal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (sarcoidosis FDG PET-CT)

Patients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy.

Group Type EXPERIMENTAL

Fludeoxyglucose F-18

Intervention Type OTHER

Given FDG

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET-CT

Computed Tomography

Intervention Type PROCEDURE

Undergo PET-CT

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Fludeoxyglucose F-18

Given FDG

Intervention Type OTHER

Positron Emission Tomography

Undergo PET-CT

Intervention Type PROCEDURE

Computed Tomography

Undergo PET-CT

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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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 Medical Imaging PET PET SCAN Positron Emission Tomography Scan proton magnetic resonance spectroscopic imaging Positron-Emission Tomography PT CAT CAT Scan Computed Axial Tomography computerized axial tomography Computerized Tomography CT CT SCAN tomography

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No