Immunoscore in Rectal Cancer

NCT02017509 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2018-08-29

No results posted yet for this study

Summary

This is an observational study of tumor samples and MRI imaging in patients with colorectal cancers. A tumor sample, MRI scans, and treatment outcome data will be used for research purposes to see if it is possible to predict patients' response to treatment.

Conditions

  • Cancer of the Rectum
  • Neoplasms, Rectal
  • Rectal Cancer
  • Rectal Tumors
  • Rectal Adenocarcinoma

Interventions

PROCEDURE

Diagnostic Biopsy and Surgical Procedure

A tumor sample from the diagnostic biopsy and surgical procedure will be used for research.

PROCEDURE

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.

PROCEDURE

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.

GENETIC

RNA gene expression analysis

RNA will be collected from biopsy and surgical tissue for gene expression analysis.

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER
  • Providence Health & Services

    lead OTHER

Principal Investigators

  • Marka Crittenden, MD, PhD · Earle A. Chiles Research Institute at Providence Health & Services

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-24
Primary Completion
2018-07-17
Completion
2018-07-17

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02017509 on ClinicalTrials.gov