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

This study has suspended participant recruitment.
(Temporary suspension of approval)
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01721785
First received: November 1, 2012
Last updated: November 11, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Rectal Neoplasms
Magnetic Resonance Imaging
Neoplasms Staging
Drug: Gadofosveset trisodium

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Diagnostic performance of the techniques under investigation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • To determine the inter-observer agreement for the imaging techniques under investigation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Detection of the differences between expert vs non-expert readers and general vs referral centres concerning diffusion-weighted imaging and gadofosveset-enhanced MRI.


Estimated Enrollment: 450
Study Start Date: October 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned 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.

Drug: Gadofosveset trisodium
Gadofosveset will be used as a lymph-node specific MRI contrast agent and will be administered by manual injection as a single intravenous bolus during MRI.
Other Names:
  • Ablavar
  • MS-325
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.

Drug: Gadofosveset trisodium
Gadofosveset will be used as a lymph-node specific MRI contrast agent and will be administered by manual injection as a single intravenous bolus during MRI.
Other Names:
  • Ablavar
  • MS-325

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients diagnosed with rectal cancer in one of the participating centres will be considered for inclusion in the study.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721785

Locations
Netherlands
Atrium Medisch Centrum
Heerlen, Limburg, Netherlands, 6401 CX
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6202 AZ
Orbis Medisch Centrum
Sittard-Geleen, Limburg, Netherlands, 6130 MB
Viecuri Medisch Centrum
Venlo, Limburg, Netherlands, 5912 BL
Jeroen Bosch Ziekenhuis
's Hertogenbosch, Noord-Brabant, Netherlands, 5223 GZ
Amphia Ziekenhuis
Breda, Noord-Brabant, Netherlands, 4800 RL
Catharina Ziekenhuis
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
Maxima Medisch Centrum
Veldhoven, Noord-Brabant, Netherlands, 5500 MB
AMC
Amsterdam, Noord-Holland, Netherlands, 1100 DD
ZGT
Almelo, Overrijsel, Netherlands, 7600 SZ
Sponsors and Collaborators
Maastricht University Medical Center
Dutch Cancer Society
Investigators
Principal Investigator: Regina Beets-Tan, Prof. MD. Radiology, MUMC
Principal Investigator: Geerard Beets, Ass Prof. MD Surgery, MUMC
Study Chair: Doenja Lambregts, MD Radiology, MUMC
Study Chair: Monique Maas, MD Radiology, MUMC
  More Information

Publications:

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01721785     History of Changes
Other Study ID Numbers: 12-2-051, 2012-002935-27
Study First Received: November 1, 2012
Last Updated: November 11, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Nodal imaging
Restaging

Additional relevant MeSH terms:
Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Gadofosveset trisodium
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014