Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer

Completed

• Conditions: Rectal Neoplasms; Neoplasms Staging; Magnetic Resonance Imaging
• Interventions: Drug: GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar]

• Registration Number: NCT01721785
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

The purpose of this study is to determine the clinical value of the novel MRI-techniques DWI and gadofosveset-enhanced MRI for the management of rectal cancer patients.

Detailed Description

Rectal cancer is a common form of cancer, and the treatment stratification depends on tumour and nodal stage as determined on MRI. Unfortunately, the information provided by standard T2-weighted MRI is not sufficient to accurately assess nodal involvement and tumour response after neo-adjuvant chemoradiotherapy. Additional functional information is required for reliable (re)staging. Diffusion-weighted imaging and gadofosveset-enhanced MRI are two new imaging techniques that have all shown great potential in rectal cancer staging. In order to provide definite evidence there is a need for a multicenter study with a large patient population.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-01
• Study First Submitted QC: 2012-11-02
• Study First Posted: 2012-11-06
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

Inclusion Criteria

• Biopsy proven primary rectal cancer (≤15 cm from the anorectal verge as measured in MRI)
• Age > 18 years
• Written informed consent

Exclusion Criteria

• Ineligibility to undergo MRI (claustrophobia, pacemaker, non-MR compatible surgical implants, metal fragments in the eye)
• Pregnancy
• Locally recurrent rectal cancer
• A history of severe allergy to contrast agents
• Ineligibility to receive gadofosveset contrast (history of contrast allergy, impaired kidney function with a Glomerular Filtration Rate <30 ml/min/1.73m2
• Incurable disease due to metastases or co-morbidity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Restaging group II	GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar]	All patients will be treated according to standard practice of the concerning hospital. Patients in group II are patients that will be stratified for a long course of chemoradiotherapy. Group II will undergo a staging MRI, a re-staging MRI and a optional sigmoidoscopy as part of restaging. MRI includes diffusion-weighted imaging and gadofosveset-enhanced MRI.
Primary staging group I	GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar]	All patients will be treated according to standard practice of the concerning hospital. Patients in group I are patients that will be stratified for direct surgery (TME) or a short-course of radiotherapy (5x5 Gy) followed by immediate TME. Group I will undergo only a staging MRI, including gadofosveset-enhanced MRI.

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of the techniques under investigation	2 years	Techniques under investigation are diffusion-weighted imaging for tumour response assessment and gadofosveset-enhanced MRI for nodal assessment, compared to standard T2-weighted MRI.

Secondary Outcome Measures

Name	Time	Method
To determine the inter-observer agreement for the imaging techniques under investigation	2 years	Detection of the differences between expert vs non-expert readers and general vs referral centres concerning diffusion-weighted imaging and gadofosveset-enhanced MRI.

Trial Locations

Locations (10)

AMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Atrium Medisch Centrum; 🇳🇱 Heerlen, Limburg, Netherlands

Maxima Medisch Centrum; 🇳🇱 Veldhoven, Noord-Brabant, Netherlands

ZGT; 🇳🇱 Almelo, Overrijsel, Netherlands

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands

Amphia Ziekenhuis; 🇳🇱 Breda, Noord-Brabant, Netherlands

Viecuri Medisch Centrum; 🇳🇱 Venlo, Limburg, Netherlands

Jeroen Bosch Ziekenhuis; 🇳🇱 's Hertogenbosch, Noord-Brabant, Netherlands

Orbis Medisch Centrum; 🇳🇱 Sittard-Geleen, Limburg, Netherlands