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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Liver Metastases

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Kartik Jhaveri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto

Authority:

Canada: Ethics Review Committee

Study ID:

UHN100405CE2010

NCT ID:

NCT01255007

Start Date:

September 2010

Completion Date:

January 2012

Related Keywords:

  • Colorectal Liver Metastases
  • Colorectal
  • liver
  • metastases
  • Primovist
  • MRI
  • CT
  • cancer
  • resection
  • MDCT
  • Diffusion
  • Weighted
  • 3T
  • Body Weight
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms

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