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

Colorectal Liver Metastases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255007
• Other study ID #: UHN100405CE2010
• Status: Completed
• Phase: N/A
• First received: December 3, 2010
• Last updated: January 6, 2015
• Start date: September 2010
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Other:
• MR imaging
Primovist enhanced MRI, Diffusion weighted MRI

Locations

Country	Name	City	State
Canada	University Health Network-Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Bayer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		18 months	No
Secondary	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.		18 months	No
Secondary	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.		18 months	No
Secondary	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.		18 months	No
Secondary	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.		18 months	No