Gene Expression and FDG PET/MRI in Evaluating Treatment Response in Patients With Locally Advanced Rectal Cancer Undergoing Chemotherapy and Radiation Therapy Before Surgery
NCT ID: NCT02112162
Last Updated: 2016-12-08
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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TERMINATED
PHASE1
2 participants
INTERVENTIONAL
2014-06-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (FDG PET/MRI, gene expression)
FDG PET/MRI at baseline and at 2-4 weeks before surgery (after neoadjuvant chemoradiation). Tissue samples for gene expression at baseline and during surgery
fludeoxyglucose F 18
Undergo FDG PET/MRI
positron emission tomography
Undergo FDG PET/MRI
magnetic resonance imaging
Undergo FDG PET/MRI
laboratory biomarker analysis
Correlative studies
Interventions
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fludeoxyglucose F 18
Undergo FDG PET/MRI
positron emission tomography
Undergo FDG PET/MRI
magnetic resonance imaging
Undergo FDG PET/MRI
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Surgical candidate.
* Candidate for neoadjuvant chemotherapy.
* Clinical evidence of T1-3N1 or T3N0 disease. This can be either by imaging studies or by physical exam findings.
* At least 18 years of age.
* Zubrod performance status of 0-2.
* Able to understand and willing to sign a written informed consent document.
* Patients with distant metastatic disease will be eligible if they satisfy all other conditions.
Exclusion Criteria
* Past history of pelvic radiotherapy.
* Received prior chemotherapy for colorectal cancer.
* Uncontrolled diabetes with a fasting glucose ≥ 200 mg/dl at the time of PET/MRI imaging.
* Claustrophobia or any other contraindication to MRI imaging evaluated by a standardized safety questionnaire.
* Renal insufficiency (defined as glomerular filtration rate (GFR \< 30 mL/min/1.73 m2) measured no more than 60 days before the first research scan) which precludes safe administration of the contrast agent.
* Currently on dialysis.
* Known prior allergic reaction to gadolinium-based MR contrast agents.
18 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Parag Parikh, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201401064
Identifier Type: -
Identifier Source: org_study_id