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
3 participants
OBSERVATIONAL
2014-01-24
2018-07-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rectal Cancer Patients
Patients with a diagnosis adenocarcinoma of the rectum will provide a tumor sample from their diagnostic biopsy and surgical procedure for research purposes, including RNA gene expression analysis. In addition to a standard MRI, patients will have an Intravoxel Incoherent Motion MRI (IVIM) and a Dynamic Contrast Enhanced MRI (DCE-MRI) for research purposes.
Diagnostic Biopsy and Surgical Procedure
A tumor sample from the diagnostic biopsy and surgical procedure will be used for research.
Intravoxel incoherent motion MRI (IVIM)
At the end of a standard MRI, we will perform IVIM, which is a diffusion-weighted imaging sequence that simultaneously characterizes the microscopic diffusivity of water and the macroscopic transport of water via bulk flow. IVIM may more accurately reflect the properties of the tumor microenvironment including vascular permeability, interstitial fluid pressure, and response to neoadjuvant therapy.
Dynamic Contrast Enhanced MRI (DCE-MRI)
Following a standard MRI scan, Dynamic Contrast Enhanced MRI (DCE-MRI) will be done. DCE-MRI is an indicator-dilution experiment in which the delivery and transcapillary transfer of a contrast agent, typically one of a number of gadolinium-based contrast agents (GBCA), is used to assess a number of parameters characterizing tissue physiology. In locally advanced rectal cancer patients, use of DCE-MRI for determining pathologic response has produced equivocal results but more promising data has been published recently in the cervical cancer literature.
RNA gene expression analysis
RNA will be collected from biopsy and surgical tissue for gene expression analysis.
Interventions
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Diagnostic Biopsy and Surgical Procedure
A tumor sample from the diagnostic biopsy and surgical procedure will be used for research.
Intravoxel incoherent motion MRI (IVIM)
At the end of a standard MRI, we will perform IVIM, which is a diffusion-weighted imaging sequence that simultaneously characterizes the microscopic diffusivity of water and the macroscopic transport of water via bulk flow. IVIM may more accurately reflect the properties of the tumor microenvironment including vascular permeability, interstitial fluid pressure, and response to neoadjuvant therapy.
Dynamic Contrast Enhanced MRI (DCE-MRI)
Following a standard MRI scan, Dynamic Contrast Enhanced MRI (DCE-MRI) will be done. DCE-MRI is an indicator-dilution experiment in which the delivery and transcapillary transfer of a contrast agent, typically one of a number of gadolinium-based contrast agents (GBCA), is used to assess a number of parameters characterizing tissue physiology. In locally advanced rectal cancer patients, use of DCE-MRI for determining pathologic response has produced equivocal results but more promising data has been published recently in the cervical cancer literature.
RNA gene expression analysis
RNA will be collected from biopsy and surgical tissue for gene expression analysis.
Eligibility Criteria
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Inclusion Criteria
* Age \> 18
* Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.
Exclusion Criteria
* Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol.
18 Years
ALL
No
Sponsors
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Oregon Health and Science University
OTHER
Providence Health & Services
OTHER
Responsible Party
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Principal Investigators
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Marka Crittenden, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Earle A. Chiles Research Institute at Providence Health & Services
Locations
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Providence Health & Services
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Countries
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Related Links
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Providence Cancer Center
Other Identifiers
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13-107A
Identifier Type: -
Identifier Source: org_study_id
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