A Head-to-head Comparison of MRI, CT, 18F-FDGal and 18F-choline in Patients With Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
18F-FDGal PET/CT versus 18F-choline PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- patients with hepatocellular carcinoma
- age above 18 years
Exclusion Criteria:
- the patient does not want to take part in the study
- the responsible investigator determines that the patient is not qualified for a PET scan
- a history of moderate or intense hypersensitivity to a gadolinium-based contrast agent
- renal insufficiency (estimated glomerular filtration rate [eGFR] <30 ml/min/1.73 m2 body surface area
- contraindications for MRI including claustrophobia
- pregnant or nursing patients.
Sites / Locations
- Aarhus University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Head-to-head comparison of two tracers: 18F-FDGal PET/CT, 18F-choline PET/CT
Arm Description
Diagnostic scan
Outcomes
Primary Outcome Measures
Hepatocellular carcinoma - sensitivity and specificity of two PET tracers
The ability of the scans 18F-FDGal PET/CT or PET/MRI and 18F-choline PET/CT or PET/MRI to correctly identify lesions representing intrahepatic and/or extrahepatic hepatocellular carcinoma.
Secondary Outcome Measures
Hepatocellular carcinoma - sensitivity and specificity of MRI and CT
The ability of MRI and CT to correctly identify lesions representing hepatocellular carcinoma.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05359939
Brief Title
A Head-to-head Comparison of MRI, CT, 18F-FDGal and 18F-choline in Patients With Hepatocellular Carcinoma
Official Title
A Head-to-head Comparison of MRI, CT, 18F-FDGal and 18F-choline in Patients With Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hepatocellular carcinoma (HCC) is the most common primary liver tumour and is the fourth leading cause of cancer-related death worldwide. In Denmark, the incidence of HCC is 5.2 per 100.000 population per year with a dismal prognosis as the median survival time is just 7.7 month. Extrahepatic spread of HCC is common at advanced stages.
The majority of patients who develop HCC has cirrhosis of the liver and in these patients, diagnosis can be made non-invasively with characteristic contrast-enhancement pattern on CT and/or MRI. Although contrast-enhanced CT and MRI are considered equal in current guidelines, MRI may have a better sensitivity especially for small lesions.
Positron emission tomography (PET) is a molecular imaging technique based on the injection of a very small dose of a tracer substance labelled with a positron emitting radioisotope. PET with the glucose tracer 18F-FDG is an important tool in the staging of many cancer forms, but it is not included in the international guidelines for management of HCC because of suboptimal sensitivity of only up to 50-60 % for HCC situated in the liver. Other PET tracers such as 11C- or 18F-choline have also been investigated in patients with HCC with detection rates of 84% in meta-analysis.
In Aarhus, the liver specific tracer 18F-FDGal has been developed. It is a fluorine-18 labelled galactose analogue which in the human body is trapped in hepatocytes by phosphorylation by galactokinase. The first study of the diagnostic use of 18F-FDGal PET/CT in patients suspected for having HCC was published in 2011. The study showed good clinical potential for 18F-FDGal as a tracer for detection of intra- as well as extrahepatic HCC.
Both 18F-choline and 18F-FDGal show potential to improve the detection of extrahepatic disease. Some centres use 18F-choline PET/CT in evaluation of patients with HCC, but the reported results for choline PET/CT do not appear superior to 18F-FDGal PET/CT. Furthermore, 18F-FDGal PET/CT also enables evaluation of regional metabolic liver. A head-to-head study of the two tracers is very much warranted.
The aim of the present project is to establish the clinical impact and utilization of 18F-FDGal PET in concert with state-of-the art radiological methods (CT and MRI) in patients with HCC.
Hypotheses:
i) 18F-FDGal PET performs better than 18F-choline for diagnosis and staging of patients with HCC.
ii) MRI is expected to perform better than contrast-enhanced CT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Head-to-head comparison of two tracers: 18F-FDGal PET/CT, 18F-choline PET/CT
Arm Type
Other
Arm Description
Diagnostic scan
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-FDGal PET/CT versus 18F-choline PET/CT
Intervention Description
Fifty patients with known HCC are investigated with two PET/CT-scans with 18F-FDGal and 18F-choline. In some of the cases one of the CT-scans will be altered to a contrast-enhanced MRI scan. A contrast-enhanced CT scan will be performed as part of the standard diagnostic work-up. We include patients with known HCC as the aim is to compare the diagnostic performance of the two tracers. Images will be analyzed for focal lesions and compared to other modalities by an experienced specialist in PET and an experienced radiologist.
Primary Outcome Measure Information:
Title
Hepatocellular carcinoma - sensitivity and specificity of two PET tracers
Description
The ability of the scans 18F-FDGal PET/CT or PET/MRI and 18F-choline PET/CT or PET/MRI to correctly identify lesions representing intrahepatic and/or extrahepatic hepatocellular carcinoma.
Time Frame
Three years
Secondary Outcome Measure Information:
Title
Hepatocellular carcinoma - sensitivity and specificity of MRI and CT
Description
The ability of MRI and CT to correctly identify lesions representing hepatocellular carcinoma.
Time Frame
Three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with hepatocellular carcinoma
age above 18 years
Exclusion Criteria:
the patient does not want to take part in the study
the responsible investigator determines that the patient is not qualified for a PET scan
a history of moderate or intense hypersensitivity to a gadolinium-based contrast agent
renal insufficiency (estimated glomerular filtration rate [eGFR] <30 ml/min/1.73 m2 body surface area
contraindications for MRI including claustrophobia
pregnant or nursing patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mona Kristiansen, MD
Phone
+4527491598
Email
mkk@clin.au.dk
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona Kristiansen, MD
Email
mkk@clin.au.dk
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
According to local rules and GDPR it is not possible for study data to leave the facility.
Learn more about this trial
A Head-to-head Comparison of MRI, CT, 18F-FDGal and 18F-choline in Patients With Hepatocellular Carcinoma
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