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Completed

NCT Number: NCT01816607

Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness

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.

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Key information

Conditions

Rectal Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

new functional magnetic resonance imaging (MRI) protocols

Procedure

diffusion-weighted MRI, dynamic-contrast enhanced MRI, MR spectroscopy, blood-level oxygen dependent (BOLD) MRI

Primary outcomes

  1. Presence of metastatic disease 5 years after rectal cancer treatment

    Time frame: five years

Secondary outcomes

  1. Histomorphological response to preoperative chemoradiotherapy

    Time frame: 8 weeks

Other outcomes

  1. Detection of regional malignant lymph nodes at time of diagnosis

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • Oslo University Hospital
  • University of Oslo

Registry information

Acronym: OxyTarget

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 22, 2013
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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