Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer
Overview
- Phase
- N/A
- Intervention
- GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar]
- Conditions
- Rectal Neoplasms
- Sponsor
- Maastricht University Medical Center
- Enrollment
- 307
- Locations
- 10
- Primary Endpoint
- Diagnostic performance of the techniques under investigation
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Primary staging group I
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.
Intervention: GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar]
Restaging group II
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.
Intervention: GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar]
Outcomes
Primary Outcomes
Diagnostic performance of the techniques under investigation
Time Frame: 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 Outcomes
- To determine the inter-observer agreement for the imaging techniques under investigation(2 years)