Phase
Condition
Esophageal Disorders
Digestive System Neoplasms
Treatment
Biospecimen Collection
Magnetic Resonance Imaging of the Heart
Computed Tomography
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients who have been evaluated by a radiation oncologist and have been felt to besuitable to undergo thoracic RT for histologically confirmed NSCLC with a dose rangeof 60-70 Gy at 1.8-2 Gy per fraction OR histologically confirmed clinical stageI-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 Gyat 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 asparticipation in this study does not interfere with activities required in the otherstudies
Patients with no contra-indications to magnetic resonance (MR) or PET imaging asstated in the section exclusion criteria
For the delayed enhancement and the T1 contrast mapping portions of the study, thepatient must have an adequate baseline renal function defined as an estimatedglomerular filtration rate (eGFR) > 30 ml/min per the Ohio State InstitutionalGuidelines. Of note, if the patient's eGFR is =< 30 ml/min, the patient would stillbe eligible for enrollment, but only the strain-encoded (SENC) imaging and T2mapping non-contrast sequences would be obtained. The dynamic contrast-enhanced (DCE) and T1 mapping sequences, which require intravenous (IV) contrast, would notbe included
Patients with moderate to end-stage renal disease, or who are at high-risk ofnephrogenic systemic fibrosis (e.g. hepatorenal syndrome, liver transplant, acuterenal failure, chronic kidney disease, and iron overload conditions) would still beeligible for enrollment, but only the non-contrast SENC and T2 mapping imagingsequences would be obtained. The DCE and T1 mapping sequences, which require IVcontrast, would not be included
Age >= 18 years old
Within 4 weeks of study entry: patients must have vital signs, history/physicalexamination, and kidney function test (eGFR)
Ability to provide written informed consent obtained prior to participation in thestudy 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 anacceptable pregnancy assessment
Exclusion
Exclusion Criteria:
Subjects who are breast-feeding, or have a positive pregnancy test will be excludedfrom the study. Should a woman become pregnant or suspect she is pregnant whileparticipating 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, nursingmothers, weight greater than 350 pounds)
Subjects with advanced renal disease (eGFR < 45 mL/min/1.72m^2) - exclusion fromreceipt of contrast, but may still be enrolled for basic CMR imaging (leftventricular ejection [LVEF], strain, T2, etc)
Medical contraindications to PET imaging (e.g. pregnancy, nursing mothers, weightgreater than 420 pounds - scanner limit)
Any serious and/or unstable pre-existing medical disorder (aside from malignancyexception above), psychiatric disorder, or other condition that could preventcompliance with study procedures or providing informed consent
Subjects who are prisoners
Study Design
Study Description
Connect with a study center
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United StatesActive - Recruiting

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