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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Hospital, Akershus
Sponsor:
Collaborators:
Oslo University Hospital
University of Oslo
Information provided by (Responsible Party):
Kathrine Røe, University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT01816607
First received: March 20, 2013
Last updated: November 7, 2013
Last verified: November 2013
  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 University Hospital, Akershus:

Primary Outcome Measures:
  • Presence of metastatic disease 5 years after rectal cancer treatment [ Time Frame: five years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Histomorphological response to preoperative chemoradiotherapy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Detection of regional malignant lymph nodes at time of diagnosis [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 20, 2013
Last Updated: November 7, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 20, 2014