Clinical trial · Interventional
Gadofosveset Trisodium (Ablavar, Gdfos) in Distinguishing Hemangiomas and Metastases: A Prospective Trial
NCT02036008CI-TRIAL-00013452unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if Gadofosveset Trisodium (Gdfos, Ablavar) is a useful magnetic resonance imaging (MRI) contrast agent in accurately diagnosing liver metastases compared to the standard agent gadobutrol (EcGd, Gadovist).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Metastases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liver MRI with EcGd | Other | — | UNRESOLVED |
| Liver MRI with Gdfos | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Liver MRI with EcGd and with Gdfos
- description
- 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.
- interventionNames
- Other: Liver MRI with Gdfos
- Other: Liver MRI with EcGd
Primary outcomes (1)
- measure
- Reader diagnostic accuracy using Gdfos vs. EcGd compared to gold standard
- timeFrame
- 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.
- description
- 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).
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDMilot L, Haider M, Foster L, McGregor C, Law C. Gadofosveset trisodium in the investigation of focal liver lesions in noncirrhotic liver: Early experience. J Magn Reson Imaging. 2012 Sep;36(3):738-42. doi: 10.1002/jmri.23650. Epub 2012 Apr 5. PMID 22488745