Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bayer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR imaging | Other | Primovist enhanced MRI, Diffusion weighted MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kartik Jhaveri, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network-Princess Margaret Hospital | Toronto | Ontario | M5G 2L7 | Canada |
Not provided
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |