Hepatocellular CarcinomaNCT01213758
Changes in Liver Function After Stereotactic Body Radiation Therapy Measured by PET/CT
An observational study of Hepatocellular Carcinoma and Cholangiocarcinoma, run by University of Aarhus at 1 site in Denmark.
Trial summary
Patients treated with stereotactic radiotherapy for liver tumors undergo PET/CT using the galactose analogue 18-F-deoxy-galactose (FDGal) before and after radiotherapy. This technique provides volumetric mapping of liver function and it allows quantisation of liver function. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hepatocellular Carcinoma, Cholangiocarcinoma, Metastases
- What is being tested?
- Measuring liver function by PET/CT
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2010to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with liver tumors reffered for stereotactic body radiation therapy
Who may be able to join
- liver tumor
- referred for stereotactic radiation therapy
- age > 18 years
Who cannot join
- Impaired kidney function
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiation Induced Change of Liver Function Measured by Uptake of the Galactose Analogue FDGal and PET/CT
Patients treated with stereotactic radiotherapy for liver tumors undergo PET/CT using the galactose analogue 18-F-deoxy-galactose (FDGal) before and after radiotherapy. This technique provides volumetric mapping of liver function and it allows quantisation of liver function. The method may be used for selection of patients for stereotactic radiotherapy of liver tumors, for determination of radiation induced liver dysfunction and may be included into the treatment planning process of stereotactic radiotherapy.
- Being tested
- Measuring liver function by PET/CT
- Keywords
- liver function, galactose, 18-F-deoxy-galactose, PET/CT, stereotactic body radiation therapy, SBRT
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring liver function by PET/CTOther
Measuring liver function by use of FDGal and PET/CT before, 1 month and 3 months after stereotactic radiotherapy for liver tumors
| Study group | Role | What they receive |
|---|---|---|
| Liver tumors | Patients where stereotactic body radiation therapy is planned for primary or metastatic liver tumors. Receives: Other: Measuring liver function by PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of FDGal
Volumetric uptake of FDGal can be measured is measured by PET/CT
Measured: Before, 1 month and 3 months after stereotactic radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2016
- Study completionApr 2016
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Sponsor
- Investigators
- Morten Høyer, MD PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213758
- Sponsor's protocol ID
- AarhusLiverRadGal
- Status last verified
- Oct 2017
- First submitted
- 1 Oct 2010
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Induced Change of Liver Function Measured by Uptake of the Galactose Analogue FDGal and PET/CT
- ClinicalTrials.gov ID
- NCT01213758
- Acronym / sponsor ID
- AarhusLiverRadGal
- Keywords
- liver function, galactose, 18-F-deoxy-galactose, PET/CT, stereotactic body radiation therapy, SBRT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- Jun 2010
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 4 Oct 2010 (estimated)
- 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.
Patients treated with stereotactic radiotherapy for liver tumors undergo PET/CT using the galactose analogue 18-F-deoxy-galactose (FDGal) before and after radiotherapy. This technique provides volumetric mapping of liver function and it allows quantisation of liver function. The method may be used for selection of patients for stereotactic radiotherapy of liver tumors, for determination of radiation induced liver dysfunction and may be included into the treatment planning process of stereotactic radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver tumors | – | Other: Measuring liver function by PET/CTPatients where stereotactic body radiation therapy is planned for primary or metastatic liver tumors. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver tumors reffered for stereotactic body radiation therapy
Key inclusion criteria (3 listed)
- liver tumor
- referred for stereotactic radiation therapy
- age > 18 years
Key exclusion criteria (2 listed)
- Impaired kidney function
- Pregnancy
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 |
|---|---|---|
| Measuring liver function by PET/CTMeasuring liver function by use of FDGal and PET/CT before, 1 month and 3 months after stereotactic radiotherapy for liver tumors | Other | Liver tumors |
Primary outcome
Uptake of FDGal
Time frame: Before, 1 month and 3 months after stereotactic radiotherapy
Volumetric uptake of FDGal can be measured is measured by PET/CT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- The Lundbeck Foundation Centre for Interventional Research in Radiation OncologyLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Morten Høyer, MD PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Cholangiocarcinoma, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 30 Oct 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of FDGal (time frame: Before, 1 month and 3 months after stereotactic radiotherapy). 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 30 Oct 2017; AzTrials last refreshed its copy on 29 Oct 2026.