Trial Title:
Imaging and Blood-Based Biomarkers for the Evaluation of Early Signs of Myocardial Injury After Thoracic Radiation Therapy
NCT ID:
NCT05717998
Condition:
Lung Non-Small Cell Carcinoma
GastroEsophageal Cancer
Esophagus Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Esophageal Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Ancillary-correlative (CMR, PET/CT, biospecimen collection)
Other name:
Biological Sample Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo cardiac PET/CT
Arm group label:
Ancillary-correlative (CMR, PET/CT, biospecimen collection)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging of the Heart
Description:
Undergo CMR
Arm group label:
Ancillary-correlative (CMR, PET/CT, biospecimen collection)
Other name:
Cardiac MRI
Other name:
Heart MRI
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo cardiac PET/CT
Arm group label:
Ancillary-correlative (CMR, PET/CT, biospecimen collection)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
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. 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.
Detailed description:
PRIMARY OBJECTIVES:
I. 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:
I. 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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eric D. Miller, MD, PhD
Email:
Eric.Miller@osumc.edu
Investigator:
Last name:
Eric D. Miller, MD, PhD
Email:
Principal Investigator
Start date:
April 2, 2021
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05717998
http://cancer.osu.edu
