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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Kathrine Røe, University Hospital, Akershus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01816607
First Posted: March 22, 2013
Last Update Posted: June 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Oslo University Hospital
University of Oslo
Information provided by (Responsible Party):
Kathrine Røe, University Hospital, Akershus
  Purpose
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.

Condition Intervention
Rectal Diseases Rectal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Procedure: new functional magnetic resonance imaging (MRI) protocols

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness

Resource links provided by NLM:


Further study details as provided by Kathrine Røe, University Hospital, Akershus:

Primary Outcome Measures:
  • Presence of metastatic disease 5 years after rectal cancer treatment [ Time Frame: five years ]

Secondary Outcome Measures:
  • Histomorphological response to preoperative chemoradiotherapy [ Time Frame: 8 weeks ]

Other Outcome Measures:
  • Detection of regional malignant lymph nodes at time of diagnosis [ Time Frame: 8 weeks ]

Biospecimen Retention:   Samples With DNA
Blood, rectal cancer tissue, normal tissue, lymph nodes

Estimated Enrollment: 200
Study Start Date: October 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Rectal cancer patients referred to radical surgery, with or without preoperative chemoradiotherapy.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816607


Contacts
Contact: Kathrine Røe, PhD +4792437646 kathrine.roe@ahus.no
Contact: Anne H Ree, MD, PhD a.h.ree@medisin.uio.no

Locations
Norway
Akershus University Hospital Recruiting
Lørenskog, Akershus, Norway, 1478
Contact: Kathrine Røe, PhD    +4792437646    kathrine.roe@medisin.uio.no   
Principal Investigator: Kathrine Røe, PhD         
Sub-Investigator: Anne H Ree, MD, PhD         
Sub-Investigator: Anne Negård, MD, PhD         
Sub-Investigator: Arne S Borthne, MD, PhD         
Sub-Investigator: Arne E Færden, MD, PhD         
Sub-Investigator: Solveig N Andersen, MD, PhD         
Sponsors and Collaborators
University Hospital, Akershus
Oslo University Hospital
University of Oslo
Investigators
Principal Investigator: Kathrine Røe, PhD University Hospital, Akershus
  More Information

Responsible Party: Kathrine Røe, Postdoctoral researcher, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT01816607     History of Changes
Other Study ID Numbers: REK-2013/152
REK-2013/152 ( Other Grant/Funding Number: HSØ_2013002 )
First Submitted: March 20, 2013
First Posted: March 22, 2013
Last Update Posted: June 23, 2015
Last Verified: June 2015

Keywords provided by Kathrine Røe, University Hospital, Akershus:
Magnetic Resonance Imaging
Magnetic Resonance Imaging, Functional

Additional relevant MeSH terms:
Neoplasms
Rectal Neoplasms
Hypoxia
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Rectal Diseases
Aggression
Colorectal Neoplasms
Intestinal Neoplasms
Neoplasms by Site
Intestinal Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Behavioral Symptoms