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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Jefferson University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Fludeoxyglucose F-18

    Other intervention

    Given FDG

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET-CT

  • Computed Tomography

    Procedure/Surgery

    Undergo PET-CT

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Diagnostic (sarcoidosis FDG PET-CT)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 30 months after radiotherapy

Secondary outcomes

1

Ability of pre- to post-radiotherapy SUV changes in the heart

Measured by sarcoidosis FDG PET-CT scans.

Time frame
Up to 30 months after radiotherapy
2

Overall survival

Survival

Time frame
Up to 30 months after radiotherapy
3

Cardiac toxicity

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
4

Cardiac toxicity judged to be secondary to radiotherapy by cardiologist and radiation oncologist

Judged to be secondary to radiotherapy by cardiologist and radiation oncologist

Time frame
Up to 30 months after radiotherapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.