Liver MetastasesPhase 2NCT01861873
Functional Treatment Planning Utilizing 18-FDGal PET/CT in SBRT for Liver Metastases
A Phase 2 study testing measuring liver function by 18-FDGal PET/CT in people with Liver Metastases, run by University of Aarhus at 1 site in Denmark.
Trial summary
Background: Anatomical (traditional) stereotactic body radio therapy(SBRT) treatment planning assumes homogenous distribution of function in the normal liver tissue. In functional treatment planning, additional information on distribution of the function derived from functional imaging of normal tissue is taken into… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases
- What is being tested?
- measuring liver function by 18-FDGal PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2013to Mar 2016
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Performance status >2
- liver metastases refereed for SBRT
Who cannot join
- pregnancy
- claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study: Functional Treatment Planning Utilizing 18-FDGal PET/CT in SBRT for Liver Metastases
Background: Anatomical (traditional) stereotactic body radio therapy(SBRT) treatment planning assumes homogenous distribution of function in the normal liver tissue. In functional treatment planning, additional information on distribution of the function derived from functional imaging of normal tissue is taken into account. by functional treatment planning it becomes possible to prioritize and spare the best functioning part of an organ.
Aim: To test whether functional treatment planning based on 18-FDGal PET/CT may spare the best functioning liver tissue.
Endpoints: Reduction in hepatic systemic clearance (K) in the dynamic 18-FDGal PET/CT scan one month after SBRT compared to the baseline status in sub-volumes recieving 15 Gy or higher. Secondly, the investigators will evaluate the toxicity to SBRT by a toxicity scoring system that includes biochemical measures as well as symptomatic scores.
- Conditions
- Liver Metastases
- Being tested
- measuring liver function by 18-FDGal PET/CT
- Keywords
- liver function, galactose, 18-F-deoxy-galactose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measuring liver function by 18-FDGal PET/CTOther
| Study group | Role | What they receive |
|---|---|---|
| liver metastases | Other | measuring liver function by PET/CT at patients where SBRT is planned for liver metastases Receives: Other: measuring liver function by 18-FDGal PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
volumetric uptake values of 18-FDGal will be measured and the 18-FDGal PET/CT one month after stereotactic body radioation therapy will be compared to the baseline status in sub-volumes receiving more than 15 Gy
Measured: up to 2 years
Secondary outcomes (1)
evaluate toxicity to SBRT by toxicity scoring system that includes biochemical measures as well as symptomatic scores.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2014 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861873
- Sponsor's protocol ID
- 210982
- Status last verified
- May 2013
- First submitted
- 15 May 2013
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study: Functional Treatment Planning Utilizing 18-FDGal PET/CT in SBRT for Liver Metastases
- ClinicalTrials.gov ID
- NCT01861873
- Acronym / sponsor ID
- 210982
- Conditions
- Liver Metastases
- Keywords
- liver function, galactose, 18-F-deoxy-galactose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 24 May 2013 (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.
Background: Anatomical (traditional) stereotactic body radio therapy(SBRT) treatment planning assumes homogenous distribution of function in the normal liver tissue. In functional treatment planning, additional information on distribution of the function derived from functional imaging of normal tissue is taken into account. by functional treatment planning it becomes possible to prioritize and spare the best functioning part of an organ.
Aim: To test whether functional treatment planning based on 18-FDGal PET/CT may spare the best functioning liver tissue.
Endpoints: Reduction in hepatic systemic clearance (K) in the dynamic 18-FDGal PET/CT scan one month after SBRT compared to the baseline status in sub-volumes recieving 15 Gy or higher. Secondly, the investigators will evaluate the toxicity to SBRT by a toxicity scoring system that includes biochemical measures as well as symptomatic scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver metastases | Other | Other: measuring liver function by 18-FDGal PET/CTmeasuring liver function by PET/CT at patients where SBRT is planned for liver metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Performance status >2
- liver metastases refereed for SBRT
Key exclusion criteria (2 listed)
- pregnancy
- claustrophobia
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 18-FDGal PET/CT | Other | liver metastases |
Primary outcome
volumetric uptake values of 18-FDGal will be measured and the 18-FDGal PET/CT one month after stereotactic body radioation therapy will be compared to the baseline status in sub-volumes receiving more than 15 Gy
Time frame: up to 2 years
1 secondary outcome
evaluate toxicity to SBRT by toxicity scoring system that includes biochemical measures as well as symptomatic scores.
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing measuring liver function by 18-FDGal PET/CT in people with Liver Metastases, 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 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: status not confirmed, as of the sponsor's last update on 24 May 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
volumetric uptake values of 18-FDGal will be measured and the 18-FDGal PET/CT one month after stereotactic body radioation therapy will be compared to the baseline status in sub-volumes receiving more than 15 Gy (time frame: up to 2 years). 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 24 May 2013.