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

NCT01255007 | Completed

• 1 other identifier: UHN100405CE2010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Colorectal Liver Metastases

Keywords

Colorectal; liver; metastases; Primovist; MRI; CT; cancer; resection; MDCT; Diffusion; Weighted; 3T

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Post chemotherapy group

EXPERIMENTAL

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

Pre and Post Chemotherapy Group

EXPERIMENTAL

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

Interventions

MR imaging OTHER

Primovist enhanced MRI, Diffusion weighted MRI

Post chemotherapy group; Pre and Post Chemotherapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Bayer: collaborator

Study Sites (1)

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2L7, Canada

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms; Body Weight

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Kartik Jhaveri, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2010
• First Posted: December 7, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 7, 2015

Record last verified: 2015-01

Locations

CA (1)