Hepatocellular CarcinomaNCT05871892
18F-FDGal PET/CT and PET/MRI in Patients With Hepatocellular Carcinoma
A study testing 18F-FDGal PET/CT or PET/MRI in people with Hepatocellular Carcinoma, run by University of Aarhus at 1 site in Denmark.
Trial summary
Hepatocellular carcinoma (HCC) is the most common primary liver tumor and 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 months. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- 18F-FDGal PET/CT or PET/MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Sep 2023to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly-referred patients suspected of or diagnosed with HCC
- Age above 18 years
Who cannot join
- 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.
- Patients who are offered systemic chemotherapy or best supportive care will be excluded.
- Renal insufficiency (estimated glomerular filtration rate [eGFR] <30 ml/min/1.73 m2 body surface area).
- Pregnant or nursing patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Mona Kristiansen, MD, mkk@clin.au.dk
About this study
Official title: Clinical Impact of 18F-FDGal PET/CT and PET/MRI in Patients Suspected of or Diagnosed With Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the most common primary liver tumor and 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 months.
Extrahepatic spread of HCC is common at advanced stages with haematogenous spread to lungs, bones and adrenal glands or lymphatic spread to regional lymph nodes.
Read more
The majority of patients who develop HCC have cirrhosis of the liver and in these patients, diagnosis can be made non-invasively with characteristic contrast-enhancement pattern on computed tomography (CT) and/or magnetic resonance imaging (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-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (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.
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 of 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.
The aim of the present project is to establish the clinical impact and utilization of 18F-FDGal PET/CT and PET/MRI in patients suspected of having HCC or diagnosed with HCC, for staging and evaluation of treatment response including effect of treatment on liver function.
Hypotheses:
- Adding 18F-FDGal PET/CT or PET/MRI to diagnostic work-up of patients suspected of or diagnosed with HCC will add to the establishment of a definitive diagnosis and improve staging and thus choice of treatment.
II. The uptake pattern of 18F-FDGal in HCC provides prognostic information and can be used to evaluate regional metabolic liver function before and after loco-regional treatment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- 18F-FDGal PET/CT or PET/MRI
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDGal PET/CT or PET/MRIDiagnostic test
All patients suspected of or diagnosed with HCC will be offered an initial 18F-FDGal PET/CT or PET/MRI scan. Moreover, patients who undergo loco-regional treatment (resection, ablation (radiation or microwave), chemo- or radio-embolization) are re-examined with 18F-FDGal. The scans will be performed 1-2 months and 3-5 months after the loco-regional treatment. The images will be analyzed by an experienced PET specialist and the CT or MR images by an experienced radiologist for focal lesions and compared to other imaging modalities. The investigators expect approximately 25 patients per year during a 5-year period and as such aim at a total of 125 patients
| Study group | Role | What they receive |
|---|---|---|
| 18F-FDGal PET/CT or PET/MRI | Other | Diagnostic scan. Receives: Diagnostic Test: 18F-FDGal PET/CT or PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the PET tracer 18F-FDGal
The ability of the scan 18F-FDGal PET/CT or PET/MRI to correctly identify lesions representing intrahepatic and/or extrahepatic hepatocellular carcinoma.
Measured: Five years
Metabolic function of the liver evaluated by the PET tracer 18F-FDGal
The ability of the scan 18F-FDGal PET/CT or PET/MRI to determine the loco-regional treatment effects on metabolic liver function in other regions of the liver.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start11 Sep 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871892
- Sponsor's protocol ID
- 1-10-72-71-22
- Status last verified
- Dec 2024
- First submitted
- 15 May 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of 18F-FDGal PET/CT and PET/MRI in Patients Suspected of or Diagnosed With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05871892
- Acronym / sponsor ID
- 1-10-72-71-22
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatocellular carcinoma (HCC) is the most common primary liver tumor and 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 months.
Extrahepatic spread of HCC is common at advanced stages with haematogenous spread to lungs, bones and adrenal glands or lymphatic spread to regional lymph nodes.
The majority of patients who develop HCC have cirrhosis of the liver and in these patients, diagnosis can be made non-invasively with characteristic contrast-enhancement pattern on computed tomography (CT) and/or magnetic resonance imaging (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-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (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.
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 of 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.
The aim of the present project is to establish the clinical impact and utilization of 18F-FDGal PET/CT and PET/MRI in patients suspected of having HCC or diagnosed with HCC, for staging and evaluation of treatment response including effect of treatment on liver function.
Hypotheses:
- Adding 18F-FDGal PET/CT or PET/MRI to diagnostic work-up of patients suspected of or diagnosed with HCC will add to the establishment of a definitive diagnosis and improve staging and thus choice of treatment.
II. The uptake pattern of 18F-FDGal in HCC provides prognostic information and can be used to evaluate regional metabolic liver function before and after loco-regional treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FDGal PET/CT or PET/MRI | Other | Diagnostic Test: 18F-FDGal PET/CT or PET/MRIDiagnostic scan. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly-referred patients suspected of or diagnosed with HCC
- Age above 18 years
Key exclusion criteria (5 listed)
- 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.
- Patients who are offered systemic chemotherapy or best supportive care will be excluded.
- Renal insufficiency (estimated glomerular filtration rate [eGFR] <30 ml/min/1.73 m2 body surface area).
- Pregnant or nursing patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDGal PET/CT or PET/MRIAll patients suspected of or diagnosed with HCC will be offered an initial 18F-FDGal PET/CT or PET/MRI scan. Moreover, patients who undergo loco-regional treatment (resection, ablation (radiation or microwave), chemo- or radio-embolization) are re-examined with 18F-FDGal. The scans will be performed 1-2 months and 3-5 months after the loco-regional treatment. The images will be analyzed by an experienced PET specialist and the CT or MR images by an experienced radiologist for focal lesions and compared to other imaging modalities. The investigators expect approximately 25 patients per year during a 5-year period and as such aim at a total of 125 patients | Diagnostic test | 18F-FDGal PET/CT or PET/MRI |
Primary outcome
Sensitivity and specificity of the PET tracer 18F-FDGal
Time frame: Five years
The ability of the scan 18F-FDGal PET/CT or PET/MRI to correctly identify lesions representing intrahepatic and/or extrahepatic hepatocellular carcinoma.
Metabolic function of the liver evaluated by the PET tracer 18F-FDGal
Time frame: Five years
The ability of the scan 18F-FDGal PET/CT or PET/MRI to determine the loco-regional treatment effects on metabolic liver function in other regions of the liver.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDGal PET/CT or PET/MRI in people with Hepatocellular Carcinoma, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mona Kristiansen, MD (+4527491598, mkk@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the PET tracer 18F-FDGal (time frame: Five years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.