Actively Recruiting
Clinical Impact of 18F-FDGal PET/CT and PET/MRI in Patients Suspected of or Diagnosed With Hepatocellular Carcinoma
Led by University of Aarhus · Updated on 2024-12-20
125
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Hepatocellular carcinoma (HCC) is the most common primary liver tumor and a leading cause of cancer-related death worldwide, with poor median survival. In advanced stages, HCC often spreads beyond the liver to organs like lungs, bones, and lymph nodes. This research aims to assess the clinical impact of a new liver-specific PET tracer, 18F-FDGal, combined with PET/CT or PET/MRI scans, to improve diagnosis, staging, and evaluation of treatment response in patients suspected of or diagnosed with HCC. Participants suspected of or diagnosed with HCC will receive an initial diagnostic 18F-FDGal PET/CT or PET/MRI scan. Those undergoing loco-regional treatment such as surgery, ablation, or chemo-/radio-embolization will have follow-up scans at 1-2 months and 3-5 months after treatment. Experienced specialists will analyze these images to detect lesions and compare findings to other imaging methods. The study aims to enroll about 125 patients over five years. During the study, participants will undergo PET scans using the 18F-FDGal tracer to assess liver metabolic function and tumor characteristics. The main outcomes include measuring the sensitivity and specificity of 18F-FDGal PET imaging and evaluating liver function over five years. The study will monitor changes before and after treatment, helping to understand prognosis and treatment effects. Participation involves multiple imaging assessments and clinical evaluations throughout the study period.
CONDITIONS
Brief Title
18F-FDGal PET/CT and PET/MRI in Patients With Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly-referred patients suspected of or diagnosed with hepatocellular carcinoma
- Age above 18 years
You will not qualify if you...
- Patient does not want to take part in the study
- Investigator determines patient is not qualified for a PET scan
- Patients offered systemic chemotherapy or best supportive care
- Renal insufficiency with eGFR below 30 ml/min/1.73 m2 body surface area
- Pregnant or nursing patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants undergo an initial 18F-FDGal PET/CT or PET/MRI scan to evaluate hepatocellular carcinoma.
1 to 3 visits depending on treatment and follow-up schedule
Duration - Up to 5 years
Participants who receive loco-regional treatment are re-examined with follow-up 18F-FDGal PET/CT or PET/MRI scans 1-2 months and 3-5 months after treatment to monitor metabolic liver function and disease status.
Approximately 2 follow-up visits after loco-regional treatment
Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
Research Team
M
Mona Kristiansen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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