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

Lung Carcinoma Clinical Trial

Official title:

PET Functional Imaging to Evaluate Cardiac Radiation Damage (EUCLID)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05775939
• Other study ID #: 22D.705
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2024
• Source: Thomas Jefferson University
• Contact: Yevgeniy Vinogradskiy, MD
• Phone: 215-955-3605
• Email: yevgeniy.vinogradskiy[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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 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

Related Conditions & MeSH terms

• Carcinoma
• Esophageal Carcinoma
• Esophageal Neoplasms
• Lung Carcinoma

Intervention

Other:
• Fludeoxyglucose F-18
Given FDG

Procedure:
• Positron Emission Tomography
Undergo PET-CT
• Computed Tomography
Undergo PET-CT

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 30 months after radiotherapy
Secondary	Ability of pre- to post-radiotherapy SUV changes in the heart	Measured by sarcoidosis FDG PET-CT scans.	Up to 30 months after radiotherapy
Secondary	Overall survival	Survival	Up to 30 months after radiotherapy
Secondary	Cardiac toxicity	Assessed using >= grade 2 and >= grade cardiac events using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	Up to 30 months after radiotherapy
Secondary	Cardiac toxicity judged to be secondary to radiotherapy by cardiologist and radiation oncologist	Judged to be secondary to radiotherapy by cardiologist and radiation oncologist	Up to 30 months after radiotherapy
Secondary	Cardiac related death	Death	Up to 30 months after radiotherapy