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

Sponsor
Thomas Jefferson University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05775939
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
72.4
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fludeoxyglucose F-18
  • Procedure: Positron Emission Tomography
  • Procedure: Computed Tomography
  • Other: Questionnaire Administration
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. 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).

  2. To evaluate the ability of imaging changes in the heart to predict for cardiac toxicity.

  3. To evaluate the ability of imaging changes in the heart to predict for cardiac related death.

EXPLORATORY OBJECTIVES:

  1. To evaluate radiation treatment planning strategies to reduce risk of cardiotoxicity.

  2. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
PET fUnCtionaL Imaging to Evaluate Cardiac Radiation Damage (EUCLID)
Actual Study Start Date :
Jan 20, 2023
Anticipated Primary Completion Date :
Jan 1, 2026
Anticipated Study Completion Date :
Feb 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnostic (sarcoidosis FDG PET-CT)

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

Other: Fludeoxyglucose F-18
Given FDG
Other Names:
  • 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

    • Procedure: Positron Emission Tomography
    Undergo PET-CT
    Other Names:
  • Medical Imaging
  • PET
  • PET SCAN
  • Positron Emission Tomography Scan
  • proton magnetic resonance spectroscopic imaging
  • Positron-Emission Tomography
  • PT

    • Procedure: Computed Tomography
    Undergo PET-CT
    Other Names:
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • computerized axial tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Change in mean standardized uptake value (SUV) changes in the heart [Up to 30 months after radiotherapy]

      Measured by sarcoidosis fludeoxyglucose F-18 (FDG) positron emission tomography (PET)-computed tomography (CT) scans.

    Secondary Outcome Measures

    1. Ability of pre- to post-radiotherapy SUV changes in the heart [Up to 30 months after radiotherapy]

      Measured by sarcoidosis FDG PET-CT scans.

    2. Overall survival [Up to 30 months after radiotherapy]

      Survival

    3. Cardiac toxicity [Up to 30 months after radiotherapy]

      Assessed using >= grade 2 and >= grade cardiac events using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    4. Cardiac toxicity judged to be secondary to radiotherapy by cardiologist and radiation oncologist [Up to 30 months after radiotherapy]

      Judged to be secondary to radiotherapy by cardiologist and radiation oncologist

    5. Cardiac related death [Up to 30 months after radiotherapy]

      Death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Thomas Jefferson University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT05775939
    Other Study ID Numbers:
    • 22D.705
    First Posted:
    Mar 20, 2023
    Last Update Posted:
    Mar 20, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Deoxyglucose
    Fluorodeoxyglucose F18

    Study Results

    No Results Posted as of Mar 20, 2023