An interventional study of Primovist MRI in Hepatocellular Carcinoma, sponsored by University Health Network, Toronto. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-19.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Diagnostic
Chronic liver disease including cirrhosis is one of the most important factors in the multi-step progression of hepatocarcinogenesis, from benign regenerative nodules to early hepatocellular carcinomas (HCCs) and finally to overt HCCs. Early diagnosis of HCC, differentiation from benign hepatocellular nodules, and surgical resection of the tumor or transplantation of the liver provide the best chance for long-term survival. Several studies have evaluated MRI enhanced with superparamagnetic iron oxide, gadolinium-based contrast material, or both, for the detection and differential diagnosis of focal hepatic lesions. However, the differentiation of HCC from benign and or borderline hepatocellular nodules remains difficult, particularly in patients with cirrhosis, because of the architectural distortion of liver parenchyma and the development of cirrhotic nodules, ranging from benign regenerative nodules to overt HCC, with overlapping imaging features. Recently, gadoxetic acid (gadoliniumethoxybezyl-diethylenetriamine pentaacetic acid; Primovist®, Bayer Health Care Pharmaceuticals), a gadolinium-based paramagnetic contrast agent that produces both dynamic and liver-specific hepatobiliary MRI studies has gained widespread use. Some studies have showed that gadoxetic acid-enhanced MRI allows the accurate detection and characterization of HCC. Investigators plan to assess this in particular as it is a question of great relevance. Execution of well conducted prospective studies will also clarify inclusion of Gd-EOB-DTPA enhanced MRI as the technique of choice in evaluation of patients at risk for HCC.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 80 is above the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
a. Patients with liver cirrhosis enlisted for liver transplantation with high probability of undergoing transplantation within the ensuing 12 months
b. Patients who are diagnosed or suspected with HCC and listed for liver transplant surgery with priority MELD (Model for End-Stage Liver Disease) points based on the cancer diagnosis, regardless of whether they have or have not received pre-transplant treatments (incl. RFA, TACE, and XRT)
c. Subjects must be able to undergo MRI
Exclusion Criteria:
a. \<30 mL/min/1.73 m2
b. Elevated (>3mg/dl)
c. Pregnant and/or nursing women
d. to MRI such as pacemaker or ferromagnetic implants
e. to Primovist or to any ingredient in the formulation or component of the container
f. Younger than 18 years of age
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this project, there is only one study group which comprises of patients with Hepatocellular Carcinoma (HCC) who will undergo Liver MRI with Primovist before hepatic transplantation.
Diagnostic Test: Primovist MRI
Utility of Gd-EOB-DTPA (Primovist) enhanced Liver MRI in HCC detection and characterization in cirrhotic patients will be studied.
Comparison of Gd-EOB-DTPA enhanced liver MRI and CT scan images in characterizing cirrhotic nodules and HCC in liver transplant candidates
Time frame: 26 months
Investigation of Gd-EOB-DTPA enhanced MRI efficacy in diagnosis and staging of HCC in cirrhotic patients and its potential impact on liver transplantation eligibility in patients who are liver transplant candidates
Time frame: 26 months
Started Nov 2017 (actual). Primary completion is estimated for Dec 2021, 49 months after the start.
Of 360 non-industry interventional studies with no phase under Carcinoma, Hepatocellular, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 76. This study's planned 49 months is close to that.
Counting every sponsor, half of 384 studies reached it within 47 months; a quarter within 23 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto →