Gadofosveset Trisodium (Ablavar, Gdfos) in Distinguishing Hemangiomas and Metastases: A Prospective Trial
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| ClinicalTrials.gov Identifier: NCT02036008 |
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Recruitment Status : Unknown
Verified January 2014 by Sunnybrook Health Sciences Centre.
Recruitment status was: Recruiting
First Posted : January 14, 2014
Last Update Posted : January 14, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer Metastases Liver Neoplasms | Other: Liver MRI with Gdfos Other: Liver MRI with EcGd | Not Applicable |
The proposed study will be a single centre, prospective trial comparing the sensitivity and specificity of using Gadofosveset Trisodium (Gdfos, Ablavar) as the MRI contrast agent as compared to gadobutrol (EcGd, Gadovist).
The study population will include cancer patient's referred for an MRI study of the liver to rule out metastases. Those who meet the inclusion/exclusion criteria will their routine (clinical) MRI of the liver with EcGd. They will also receive an additional MRI with Gdfos within 4 weeks of the original study.
The patient data will be anonymized and the imaging will be read by radiologists and radiology residents and comparison will be made between the diagnostic accuracy of the EcGd-enhanced study and the Gdfos-enhanced study.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Diagnostic |
| Official Title: | Gadofosveset Trisodium (Ablavar, Gdfos) in Distinguishing Hemangiomas and Metastases: A Prospective Trial |
| Study Start Date : | August 2013 |
| Estimated Primary Completion Date : | December 2014 |
| Estimated Study Completion Date : | July 2015 |
| Arm | Intervention/treatment |
|---|---|
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Liver MRI with EcGd and with Gdfos
All participants will receive two contrast-enhanced MRI studies of the liver: one with gadofosveset trisodium (Gdfos) and one with gadobutrol (EcGd) at a dose of 0.1 mL/kg body mass up to 10 mL.
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Other: Liver MRI with Gdfos
Participants will receive Gdfos at a dose of 10 mL of 0.25mmol/mL. This will be administered automatically using an MRI-compatible power injector, as a bolus through an intravenous line placed in an antecubital vein at a rate of 1.5 mL/s followed by 25 mL of 0.9% saline flush. Participants will be imaged using a 3.0 T MRI scanner with an 8 channel body phased array coil utilized covering the entire liver. Images of the liver will be obtained including: axial precontrast phase, axial arterial phase, axial portovenous phase, axial 5 minute delayed phase, axial 10 minute delayed phase, axial 20 minute delayed phase. This study will be performed within 4 weeks of the MRI study with EcGd. Other Name: Gadofosveset trisodium (Gdfos) Other: Liver MRI with EcGd Participants will receive a liver MRI with EcGd as per clinical institutional protocol. Participants will receive EcGd at a dose of 0.1 mL/kg body mass up to 10 mL. This will be administered automatically using an MRI-compatible power injector, as a bolus through an intravenous line placed in an antecubital vein at a rate of 1.5 mL/s followed by 25 mL of 0.9% saline flush. Participants will be imaged using a 3.0 T MRI scanner with an 8 channel body phased array coil utilized covering the entire liver. Images of the liver will be obtained including: axial precontrast phase, axial arterial phase, axial portovenous phase, axial 5 minute delayed phase, axial 10 minute delayed phase, axial 20 minute delayed phase. Additional noncontrast images will be obtained as per institutional protocol, including diffusion weighted imaging, in/out of phase imaging, and T2 weighted imaging. Other Name: gadobutrol (Gadovist, EcGd) |
- Reader diagnostic accuracy using Gdfos vs. EcGd compared to gold standard [ Time Frame: Participants will receive both Gdfos and EcGd study within 4 weeks of each other. Radiologist reading for the study will be done up to 52 weeks after first MRI has been performed. ]Three blinded radiologists of different training levels will read the MRI liver studies done using Gdfos and EcGd and the results of this will be compared to a gold standard (either pathology from surgery or biopsy or long-term follow-up). The diagnostic accuracy of Gdfos vs. EcGd will be compared using area under receiver operating characteristic (ROC) curves (with correction for correlation and clustering).
- Inter-reader variability for EcGd-enhanced vs. Gdfos-enhanced imaging [ Time Frame: Participants will receive both Gdfos and EcGd study within 4 weeks of each other. Radiologist reading for the study will be done up to 52 weeks after first MRI has been performed. ]Three blinded radiologists of different training levels will read the MRI liver studies done using Gdfos and EcGd and the results of this will be compared to a gold standard (either pathology from surgery or biopsy or long-term follow-up). The difference in accuracy will be compared between readers using kappa statistics.
- Reader diagnostic accuracy of EcGd-enhanced imaging vs. Gdfos-enhanced imaging compared to gold standard (subgroup analysis for small lesions less than or equal to 1cm) [ Time Frame: Participants will receive both Gdfos and EcGd study within 4 weeks of each other. Radiologist reading for the study will be done up to 52 weeks after first MRI has been performed. ]Subgroup analysis for small lesions. The same analysis will be done with only a subgroup of small lesions.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- known cancer
- referred for MRI of liver to rule out metastases
- has focal liver lesions
- age > 18 yo
Exclusion Criteria:
- contraindication to MRI or MR contrast agents
- pregnancy
- unable to obtain all sequences and/or acceptable quality imaging
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036008
| Contact: Helen Cheung | 416-480-6100 ext 85463 | hecheung@sunnybrook.ca |
| Canada, Ontario | |
| Sunnybrook Health Sciences Centre | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Laurent Milot, MD laurent.milot@sunnybrook.ca | |
| Principal Investigator: Laurent Milot, MD | |
| Sub-Investigator: Helen Cheung, MD | |
| Sub-Investigator: Caitlin McGregor, MD | |
| Sub-Investigator: Calvin Law, MD | |
| Sub-Investigator: Paul Karanicolas, MD | |
| Principal Investigator: | Laurent Milot, MD | Sunnybrook Health Sciences Centre |
Publications:
| Responsible Party: | Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT02036008 History of Changes |
| Other Study ID Numbers: |
153-2013 |
| First Posted: | January 14, 2014 Key Record Dates |
| Last Update Posted: | January 14, 2014 |
| Last Verified: | January 2014 |
Keywords provided by Sunnybrook Health Sciences Centre:
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Liver metastases MRI Contrast Agents |
Additional relevant MeSH terms:
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Neoplasm Metastasis Neoplasms, Second Primary Hemangioma Liver Neoplasms Neoplastic Processes Neoplasms Pathologic Processes Neoplasms, Vascular Tissue |
Neoplasms by Histologic Type Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Liver Extracts Hematinics |