Lung CarcinomaNCT05775939
PET/CT Imaging to Evaluate Cardiac Radiation Damage in Patients With Lung or Esophageal Cancer, EUCLID Trial
A study testing Fludeoxyglucose F-18, Positron Emission Tomography and Computed Tomography in people with Lung Carcinoma and Esophageal Carcinoma, run by Thomas Jefferson University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Carcinoma, Esophageal Carcinoma
- What is being tested?
- Fludeoxyglucose F-18, Positron Emission Tomography and Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2023to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Yevgeniy Vinogradskiy, MD, 215-955-3605, yevgeniy.vinogradskiy@jefferson.edu
About this study
Official title: PET Functional Imaging to Evaluate Cardiac Radiation Damage (EUCLID)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To characterize radiation-related functional imaging changes in the heart using sarcoidosis fludeoxyglucose F-18 (FDG) PET-CT imaging.
SECONDARY OBJECTIVES:
- 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:
- 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
- Lung Carcinoma, Esophageal Carcinoma
- Being tested
- Fludeoxyglucose F-18, Positron Emission Tomography, Computed Tomography, Questionnaire Administration
- Medical subject headings
- Lung Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludeoxyglucose F-18Other
Also called 105851-17-0, 18FDG, 2-Deoxy-2-(18F)Fluoro-D-Glucose, 2-F18-Fluoro-2-deoxy-D-glucose
Given FDG
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, PET, PET SCAN, Positron Emission Tomography Scan
Undergo PET-CT
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography
Undergo PET-CT
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (sarcoidosis FDG PET-CT) | Experimental | Patients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy. Receives: Other: Fludeoxyglucose F-18; Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 months after radiotherapy
Secondary outcomes (5)
Ability of pre- to post-radiotherapy SUV changes in the heart
Measured by sarcoidosis FDG PET-CT scans.
Measured: Up to 30 months after radiotherapy
Overall survival
Survival
Measured: Up to 30 months after radiotherapy
Cardiac toxicity
Assessed using >= grade 2 and >= grade cardiac events using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 30 months after radiotherapy
Cardiac toxicity judged to be secondary to radiotherapy by cardiologist and radiation oncologist
Judged to be secondary to radiotherapy by cardiologist and radiation oncologist
Measured: Up to 30 months after radiotherapy
Cardiac related death
Death
Measured: Up to 30 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start20 Jan 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yevgeniy Vinogradskiy, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775939
- Sponsor's protocol ID
- 22D.705
- Other IDs
- JT 20888
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Functional Imaging to Evaluate Cardiac Radiation Damage (EUCLID)
- ClinicalTrials.gov ID
- NCT05775939
- Acronym / sponsor ID
- 22D.705
- Conditions
- Lung Carcinoma, Esophageal Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To characterize radiation-related functional imaging changes in the heart using sarcoidosis fludeoxyglucose F-18 (FDG) PET-CT imaging.
SECONDARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (sarcoidosis FDG PET-CT) | Experimental | Other: Fludeoxyglucose F-18, Procedure: Positron Emission Tomography, Procedure: Computed Tomography, Other: Questionnaire AdministrationPatients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fludeoxyglucose F-18Also: 105851-17-0, 18FDG, 2-Deoxy-2-(18F)Fluoro-D-Glucose, 2-F18-Fluoro-2-deoxy-D-glucoseGiven FDG | Other | Diagnostic (sarcoidosis FDG PET-CT) |
| Positron Emission TomographyAlso: Medical Imaging, PET, PET SCAN, Positron Emission Tomography ScanUndergo PET-CT | Procedure or surgery | Diagnostic (sarcoidosis FDG PET-CT) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomographyUndergo PET-CT | Procedure or surgery | Diagnostic (sarcoidosis FDG PET-CT) |
| Questionnaire AdministrationAncillary studies | Other | Diagnostic (sarcoidosis FDG PET-CT) |
Primary outcome
Change in mean standardized uptake value (SUV) changes in the heart
Time frame: Up to 30 months after radiotherapy
Measured by sarcoidosis fludeoxyglucose F-18 (FDG) positron emission tomography (PET)-computed tomography (CT) scans.
5 secondary outcomes
Ability of pre- to post-radiotherapy SUV changes in the heart
Time frame: Up to 30 months after radiotherapy
Overall survival
Time frame: Up to 30 months after radiotherapy
Cardiac toxicity
Time frame: Up to 30 months after radiotherapy
Cardiac toxicity judged to be secondary to radiotherapy by cardiologist and radiation oncologist
Time frame: Up to 30 months after radiotherapy
Cardiac related death
Time frame: Up to 30 months after radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yevgeniy Vinogradskiy principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fludeoxyglucose F-18, Positron Emission Tomography and Computed Tomography in people with Lung Carcinoma and Esophageal Carcinoma, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yevgeniy Vinogradskiy, MD (215-955-3605, yevgeniy.vinogradskiy@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean standardized uptake value (SUV) changes in the heart (time frame: Up to 30 months after radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.