Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness

Completed

• Conditions: Rectal Neoplasms; Rectal Diseases; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Interventions: Procedure: new functional magnetic resonance imaging (MRI) protocols

• Registration Number: NCT01816607
• Lead Sponsor: University Hospital, Akershus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-22
• Study Start: 2013-10
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rectal cancer	new functional magnetic resonance imaging (MRI) protocols	-

Primary Outcome Measures

Name	Time	Method
Presence of metastatic disease 5 years after rectal cancer treatment	five years

Secondary Outcome Measures

Name	Time	Method
Histomorphological response to preoperative chemoradiotherapy	8 weeks

Trial Locations

Locations (1)

Akershus University Hospital; 🇳🇴 Lørenskog, Akershus, Norway