Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness (OxyTarget)

November 15, 2018 updated by: Kathrine Røe Redalen, University Hospital, Akershus
The purpose of this study is to establish a reliable method for detection of rectal cancer patients with aggressive tumor at risk of metastatic disease and death by functional MRI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Akershus
      • Lørenskog, Akershus, Norway, 1478
        • Akershus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Rectal cancer patients referred to radical surgery, with or without preoperative chemoradiotherapy.

Description

Inclusion Criteria:

  • The patient is willing and able to give full written consent according to the protocol approved by the Regional Ethics Committee.
  • The patient has confirmed rectal cancer diagnosis and is scheduled to radical surgery alone or preoperative CRT followed by surgery.
  • The patient is ≥ 18 years.
  • The patient has no prior rectal cancer treatment.
  • The patient has adequate renal function: creatinine clearance ≥ 60 ml/minute.
  • The patient has signed the written informed consent according to the protocol approved by the Regional Ethics Committee.

Exclusion Criteria:

  • The patient has contraindication to MRI or MRI contrast agent according to clinical practice.
  • The patient wants to withdraw for any reason during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rectal cancer
Procedure: new functional magnetic resonance imaging (MRI) protocols
diffusion-weighted MRI, dynamic-contrast enhanced MRI, MR spectroscopy, blood-level oxygen dependent (BOLD) MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of metastatic disease 5 years after rectal cancer treatment
Time Frame: five years
five years

Secondary Outcome Measures

Outcome Measure
Time Frame
Histomorphological response to preoperative chemoradiotherapy
Time Frame: 8 weeks
8 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Detection of regional malignant lymph nodes at time of diagnosis
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Akershus

Collaborators

University of Oslo
Oslo University Hospital

Investigators

  • Principal Investigator: Kathrine Røe Redalen, PhD, University Hospital, Akershus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 20, 2013

First Posted (Estimate)

March 22, 2013

Study Record Updates

Last Update Posted (Actual)

November 19, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK-2013/152 (Other Grant/Funding Number: HSØ_2013002)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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