Recruiting

Cardiac Radiation Damage

Sponsor:

Thomas Jefferson University

Code:

NCT05775939

Conditions

Lung Carcinoma

Esophageal Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fludeoxyglucose F-18

Positron Emission Tomography

Computed Tomography

Questionnaire Administration

Study Details

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.

Conditions

Lung Carcinoma

Esophageal Carcinoma

Study ID

NCT05775939

Start date

Jan 20, 2023

Status verified date

Feb, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (sarcoidosis FDG PET-CT)

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

Interventions

Fludeoxyglucose F-18

Given FDG

Positron Emission Tomography

Undergo PET-CT

Computed Tomography

Undergo PET-CT

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Change in mean standardized uptake value (SUV) changes in the heart [ Time Frame: Up to 30 months after radiotherapy ]

Central Contacts and Locations

Central contacts

Yevgeniy Vinogradskiy, MD

215-955-3605yevgeniy.vinogradskiy@jefferson.edu

Locations

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Yevgeniy Vinogradskiy, MD

215-955-3605yevgeniy.vinogradskiy@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-02-10.