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Lung Non-Small Cell CarcinomaNCT05717998

Imaging and Blood-Based Biomarkers for the Evaluation of Early Signs of Myocardial Injury After Thoracic Radiation Therapy

An observational study of Lung Non-Small Cell Carcinoma and GastroEsophageal Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study assesses for early signs of damage to the heart following chest radiation therapy using both imaging (cardiac magnetic resonance imaging and cardiac positron emission tomography) and changes in blood biomarkers. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Computed Tomography and Magnetic Resonance Imaging of the Heart
Type of treatment
Surgery or procedure
How many people
28 participants
Where
1 siteUnited States
Study dates
2 Apr 2021to 18 Apr 2027
Phase
Observational
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

Study population: Patients suitable to undergo thoracic RT for histologically confirmed non-small cell lung cancer (NSCLC) OR histologically confirmed clinical stage I-IVA (American Joint Committee on Cancer [AJCC] 8th edition [ed]) middle or thoracic esophageal or gastroesophageal cancer (squamous cell carcinoma or adenocarcinoma) at Ohio State University Comprehensive Cancer Center

Who may be able to join

  • Patients who have been evaluated by a radiation oncologist and have been felt to be suitable to undergo thoracic RT for histologically confirmed NSCLC with a dose range of 60-70 Gy at 1.8-2 Gy per fraction OR histologically confirmed clinical stage I-IVA (AJCC 8th ed) middle or thoracic esophageal or gastroesophageal cancer (squamous cell carcinoma or adenocarcinoma) with a planned dose range of 41.4-60 Gy at 1.8-2 Gy per fraction as part of treatment of their malignancy
  • Concurrent chemotherapy is permitted
  • For NSCLC patients, both concurrent and/or adjuvant immunotherapy is permitted
  • Patients participating in other research studies are eligible as long as participation in this study does not interfere with activities required in the other studies
  • Patients with no contra-indications to magnetic resonance (MR) or PET imaging as stated in the section exclusion criteria
  • For the delayed enhancement and the T1 contrast mapping portions of the study, the patient must have an adequate baseline renal function defined as an estimated glomerular filtration rate (eGFR) > 30 ml/min per the Ohio State Institutional Guidelines. Of note, if the patient's eGFR is =< 30 ml/min, the patient would still be eligible for enrollment, but only the strain-encoded (SENC) imaging and T2 mapping non-contrast sequences would be obtained. The dynamic contrast-enhanced (DCE) and T1 mapping sequences, which require intravenous (IV) contrast, would not be included
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  • Patients with moderate to end-stage renal disease, or who are at high-risk of nephrogenic systemic fibrosis (e.g. hepatorenal syndrome, liver transplant, acute renal failure, chronic kidney disease, and iron overload conditions) would still be eligible for enrollment, but only the non-contrast SENC and T2 mapping imaging sequences would be obtained. The DCE and T1 mapping sequences, which require IV contrast, would not be included
  • Age >= 18 years old
  • Within 4 weeks of study entry: patients must have vital signs, history/physical examination, and kidney function test (eGFR)
  • Ability to provide written informed consent obtained prior to participation in the study and any study specific procedures being performed
  • Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of the study entry. Urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment

Who cannot join

  • Subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Medical contraindications to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to Gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds)
  • Subjects with advanced renal disease (eGFR < 45 mL/min/1.72m^2) - exclusion from receipt of contrast, but may still be enrolled for basic CMR imaging (left ventricular ejection [LVEF], strain, T2, etc)
  • Medical contraindications to PET imaging (e.g. pregnancy, nursing mothers, weight greater than 420 pounds - scanner limit)
  • Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other condition that could prevent compliance with study procedures or providing informed consent
  • Subjects who are prisoners

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Pilot Study to Evaluate Early Signs of Myocardial Injury After Thoracic Radiotherapy Using Imaging and Blood-Based Biomarkers

This study assesses for early signs of damage to the heart following chest radiation therapy using both imaging (cardiac magnetic resonance imaging and cardiac positron emission tomography) and changes in blood biomarkers. This study determines if any changes in the heart muscle can be detected either during the course of radiation therapy or shortly thereafter using specialized imaging techniques or blood tests. Cardiac magnetic resonance imaging may be used to help provide information about changes in the heart structure and function following radiation therapy. Positron emission tomography looks at differences in how the heart takes up radioactive sugar which is injected into the vein to assess changes in heart function following radiation therapy. This study may help identify patients at risk of heart issues following radiation therapy to the chest and ultimately help in the development of more effective and safe treatments for cancer in the future.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate and quantitate early changes in myocardial fibrosis following thoracic radiation therapy (RT).

II. To assess quantitative early changes in myocardial inflammation after thoracic RT.

III. To determine if thoracic RT is associated with early changes in myocardial metabolism as assessed with cardiac positron emission tomography (PET).

SECONDARY OBJECTIVES:

  1. To evaluate and quantitate early changes in subclinical myocardial dysfunction after thoracic RT.

II. To determine if thoracic RT is associated with early changes in myocardial metabolism using alternative cardiac PET-derived biomarkers.

III. To evaluate and quantitate early changes in blood-based biomarkers after thoracic RT.

IV. To assess the incidence and severity of cardiac events following completion of thoracic RT.

OUTLINE:

Within 2 weeks of starting RT, patients undergo cardiac magnetic resonance (CMR) imaging, cardiac positron emission tomography (PET)/computed tomography (CT) and blood sample collection at baseline, then between fractions 12-17 of RT and at 6 months after completion of RT.

Being tested
Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging of the Heart, Positron Emission Tomography
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography

    Undergo cardiac PET/CT

  • Magnetic Resonance Imaging of the HeartProcedure or surgery

    Also called Cardiac MRI, Heart MRI

    Undergo CMR

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo cardiac PET/CT

Study groups in NCT05717998
Study groupRoleWhat they receive
Ancillary-correlative (CMR, PET/CT, biospecimen collection)Within 2 weeks of starting RT, patients undergo CMR, cardiac PET/CT and blood sample collection at baseline, then between fractions 12-17 of RT and at 6 months after completion of RT.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging of the Heart; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in extracellular volume (ECV)

    To identify the presence of cardiac fibrosis as assessed by cardiac magnetic resonance-derived ECV during and shortly after RT.

    Measured: Baseline up to 6 months post-radiation therapy (RT)

  2. Changes in myocardial T2

    To identify the presence of cardiac magnetic resonance-derived cardiac inflammation using T2 mapping during and shortly after RT.

    Measured: Baseline up to 6 months post-RT

  3. Changes in myocardial metabolism

    To identify changes in myocardial metabolism measured as standardized uptake value (SUV) max during and shortly after RT using myocardial PET.

    Measured: Baseline up to 6 months post-RT

Secondary outcomes (1)

  1. Blood-based biomarkers

    Biomarkers including serum troponin, N-terminal Pro Brain-type Natriuretic Peptide (NT-proBNP), C-reactive protein, carboxy-terminal propeptide of procollagen type I (PICP), and amino-terminal propeptide of procollagen type I (PINP) will be measured.

    Measured: Baseline up 6 to months post-RT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2023
  2. Study start2 Apr 2021
  3. Primary completion18 Apr 2027 (estimated)
  4. Study completion18 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05717998
Sponsor's protocol ID
OSU-20351
Other IDs
NCI-2021-08714
Status last verified
Sep 2026
First submitted
2 Sep 2021
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Non-Small Cell Carcinoma and GastroEsophageal Cancer, run by Ohio State University Comprehensive Cancer Center 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 11 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in extracellular volume (ECV) (time frame: Baseline up to 6 months post-radiation therapy (RT)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05717998.

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 24 Sep 2026.

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