Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
23 participants
OBSERVATIONAL
2015-09-23
2019-01-31
Brief Summary
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Detailed Description
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The cardiac MRI will be performed using Aminophylline, Gadopentetate Dimeglumine and Regadenoson. These are not FDA approved for this purpose, but are being used off label and are IND exempt. Additionally, patients will be consented with an optional choice to retain research blood samples for 15 years after the completion of the study. This will allow cutting edge analysis for biomarkers that may be discovered in the future.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lung or Esophageal Patients
Patients with lung or esophageal cancer undergoing conventionally-fractionated radiation therapy. Interventions to be administered include: Imaging Biomarkers using Volumetric CT Scans, Pulmonary using Pulmonary Function Test \& 6Minute Hall Walk, Imaging using Cardiac MRI, Specimen Collection using Blood Draws.
Imaging Biomarkers
Whole lung volumetric CT scans
Pulmonary
Pulmonary Function Tests \& 6 minute hall walk
Imaging
Cardiac MRI
Specimen Collection
Blood draw
Interventions
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Imaging Biomarkers
Whole lung volumetric CT scans
Pulmonary
Pulmonary Function Tests \& 6 minute hall walk
Imaging
Cardiac MRI
Specimen Collection
Blood draw
Eligibility Criteria
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Inclusion Criteria
* Stage IIA-IIIB non-small cell lung cancer
* Limited stage small cell lung cancer
* Stage I-III esophageal cancer (neoadjuvant or definitive)
* Patients must be 18 years of age or older
* Must not be claustrophobic
* Must have adequate kidney function
Exclusion Criteria
* Patients with esophageal cancer receiving trastuzamab
* Pregnancy or lactation
* Claustrophobia
* Inability to lie flat for 60-90 minutes
* Renal dysfunction with eGFR \<60 mL/min/1.73 m2
* Allergy to gadolinium containing contrast media
* Implanted devices, metallic hazards or other conditions presenting a contraindication to 3Tesla cardiac MRI
18 Years
ALL
No
Sponsors
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Department of Health and Human Services
FED
University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Shruti Jolly, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00097162
Identifier Type: OTHER
Identifier Source: secondary_id
UMCC 2015.006
Identifier Type: -
Identifier Source: org_study_id
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