Comparison of Primovist-enhanced MRI, Diffusion Weighted MRI and Multidetector CT of Colorectal Liver Metastases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bayer
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01255007
First received: December 3, 2010
Last updated: May 26, 2011
Last verified: December 2010
  Purpose
  1. Primovist-enhanced Magnetic resonance imaging (MRI) and Diffusion Weighted MRI (DW-MRI) is superior to Multidetector Computed axial Tomography (MDCT) in the detection of colorectal liver metastases. Fatty changes in the liver after chemotherapy treatment likely reduces the chances of seeing metastatic lesions on CT especially when the lesions are small (<10 mm). When compared with CT, Primovist-enhanced MRI and DW-MRI have the potential to provide higher contrast resolution enabling better detection of colorectal liver metastases following chemotherapy.
  2. Primovist-enhanced MRI and DW-MRI are superior to CT in assessing and predicting treatment response of patients with colorectal liver metastases to chemotherapy. Primovist-enhanced MRI by providing superior resolution may provide improved accuracy in metastatic lesion margin detection thereby providing higher accuracy in estimating tumor response based on size criteria. DW-MRI provides information indirectly about tumor composition and therefore is likely to be superior to MD-CT in assessing treatment response.

Two groups of patients will be analyzed. The second group consists of patients with colorectal liver metastases who are to go for chemotherapy prior to surgery for metastases resection. This group will be CT and MRI scanned prior to chemotherapy and after chemotherapy. The first group of patients will consist of those patients who have already received chemotherapy and are likely to have surgery to resect liver metastases. This group will have only one set of scans done 4-6 weeks prior to their operation. The pathology of the resected metastases and CT and MRI images will be analyzed and compared.


Condition Intervention
Colorectal Liver Metastases
Other: MR imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Comparison of 3T Gd-EOB-DTPA-enhanced MRI, Diffusion Weighted MR Imaging and MDCT of Colorectal Liver Metastases for Preoperative Detection and Assessment of Treatment Response Following Chemotherapy Treatment

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • To establish superiority of Primovist-enhanced liver MRI and DWI to MDCT in the preoperative detection of colorectal liver metastases in patients who have received prior chemotherapy by comparison against pathology or Intra-operative ultrasound. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare diagnostic performance of MDCT, Diffusion Weighted MR and Primovist-enhanced MRI in the differentiation of viable from non-viable metastatic tumour compared to reference standard of pathology. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To investigate in the cohort of patients who have pre and post-chemotherapy MRI the role of DWI in predicting treatment response by baseline pretreatment Apparent Diffusion Coefficient (ADC) values. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To assess performance of Primovist-enhanced MRI, DW-MRI and MDCT in assessment of treatment response following chemotherapy in the cohort of patients who have pre and post-chemotherapy MRI. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To compare accuracies of Primovist-enhanced MRI and DWI to MDCT in the characterization of non-metastatic liver lesions against histopathology or intra-operative ultrasound. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Post chemotherapy group
The first group consists of patients with colorectal liver metastases who have had treatment with chemotherapy and are now awaiting surgery. This group would have had Multidetector Liver CT (MDCT) imaging prior to the chemotherapy, and will now undergo post chemotherapy MDCT as part of standard clinical care in addition to Gd-EOB-DTPA enhanced liver MRI and Diffusion Weighted MRI (DW-MRI). The MRI will be performed as an additional imaging investigation after obtaining informed consent.
Other: MR imaging
Primovist enhanced MRI, Diffusion weighted MRI
Experimental: Pre and Post Chemotherapy Group
The second group consists of patients with colorectal liver metastases who are due to receive neoadjuvant chemotherapy. This group will be imaged prior to receiving and after receiving chemotherapy. This will all be done prior to surgical resection of their colorectal liver metastases.
Other: MR imaging
Primovist enhanced MRI, Diffusion weighted MRI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with colorectal liver metastases already treated by chemotherapy and scheduled for surgical resection
  • Patients with colorectal liver metastases scheduled to receive chemotherapy with possibility of future liver resection.

Exclusion Criteria:

  • Acute or Chronic Renal Disease with Estimated GFR (eGFR) <30 mL/min.
  • Hypersensitivity to MRI contrast or CT contrast or to any ingredient in the formulation or component of the container.
  • Patients with: acute or chronic severe renal impairment (glomerular filtration rate <30 mL/min/1.73 m2), or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
  • General contraindications to MRI such as pacemaker or ferromagnetic implants.
  • Severe cardiovascular problems
  • Pregnant or nursing women
  • Age <18 years
  • Liver Surgery is not a possibility.
  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: NCT01255007

Contacts
Contact: Kartik Jhaveri, MD kartik.jhaveri@uhn.on.ca

Locations
Canada, Ontario
University Health Network-Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2L7
Contact: Kartik Jhaveri, MD       kartik.jhaveri@uhn.on.ca   
Principal Investigator: Kartik Jhaveri, MD         
Sponsors and Collaborators
University Health Network, Toronto
Bayer
Investigators
Principal Investigator: Kartik Jhaveri, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Dr. Kartik Jhaveri, University Health Network
ClinicalTrials.gov Identifier: NCT01255007     History of Changes
Other Study ID Numbers: UHN100405CE2010
Study First Received: December 3, 2010
Last Updated: May 26, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Colorectal
liver
metastases
Primovist
MRI
CT
cancer
resection
MDCT
Diffusion
Weighted
3T

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 18, 2014