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

Primary Purpose

Lung Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fludeoxyglucose F-18
Positron Emission Tomography
Computed Tomography
Questionnaire Administration
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 30 Gy in 10 fractions or 20 Gy in 5 fractions

Sites / Locations

  • Thomas Jefferson University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (sarcoidosis FDG PET-CT)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2023
Last Updated
August 14, 2023
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT05775939
Brief Title
PET/CT Imaging to Evaluate Cardiac Radiation Damage in Patients With Lung Cancer, EUCLID Trial
Official Title
PET fUnCtionaL Imaging to Evaluate Cardiac Radiation Damage (EUCLID)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2023 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
February 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (sarcoidosis FDG PET-CT)
Arm Type
Experimental
Arm Description
Patients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy.
Intervention Type
Other
Intervention Name(s)
Fludeoxyglucose F-18
Other Intervention Name(s)
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
Intervention Description
Given FDG
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, PET, PET SCAN, Positron Emission Tomography Scan, proton magnetic resonance spectroscopic imaging, Positron-Emission Tomography, PT
Intervention Description
Undergo PET-CT
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography, Computerized Tomography, CT, CT SCAN, tomography
Intervention Description
Undergo PET-CT
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in mean standardized uptake value (SUV) changes in the heart
Description
Measured by sarcoidosis fludeoxyglucose F-18 (FDG) positron emission tomography (PET)-computed tomography (CT) scans.
Time Frame
Up to 30 months after radiotherapy
Secondary Outcome Measure Information:
Title
Ability of pre- to post-radiotherapy SUV changes in the heart
Description
Measured by sarcoidosis FDG PET-CT scans.
Time Frame
Up to 30 months after radiotherapy
Title
Overall survival
Description
Survival
Time Frame
Up to 30 months after radiotherapy
Title
Cardiac toxicity
Description
Assessed using >= grade 2 and >= grade cardiac events using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time Frame
Up to 30 months after radiotherapy
Title
Cardiac toxicity judged to be secondary to radiotherapy by cardiologist and radiation oncologist
Description
Judged to be secondary to radiotherapy by cardiologist and radiation oncologist
Time Frame
Up to 30 months after radiotherapy
Title
Cardiac related death
Description
Death
Time Frame
Up to 30 months after radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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 30 Gy in 10 fractions or 20 Gy in 5 fractions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yevgeniy Vinogradskiy, MD
Phone
215-955-3605
Email
yevgeniy.vinogradskiy@jefferson.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yevgeniy Vinogradskiy
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yevgeniy Vinogradskiy, MD
Phone
215-955-3605
Email
yevgeniy.vinogradskiy@jefferson.edu

12. IPD Sharing Statement

Learn more about this trial

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

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