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

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Neoplasms Staging; Rectal Neoplasms; Magnetic Resonance Imaging

Treatments: Drug: GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar]

Study type: Observational

Funder types: Other

Identifiers

NCT01721785

12-2-051

2012-002935-27 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 307 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

307 participants in 2 patient groups

Primary staging group I

Description:

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.

Treatment:

Drug: GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar]

Restaging group II

Description:

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.

Treatment:

Drug: GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar]