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Functional Treatment Planning Utilizing 18-FDGal PET/CT in SBRT for Liver Metastases

Phase 2 Study: Functional Treatment Planning Utilizing 18-FDGal PET/CT in SBRT for Liver Metastases

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01861873
Enrollment
28
Registered
2013-05-24
Start date
2013-08-31
Completion date
2016-03-31
Last updated
2013-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Metastases

Keywords

liver function, galactose, 18-F-deoxy-galactose

Brief 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 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.

Interventions

OTHERmeasuring liver function by 18-FDGal PET/CT

Sponsors

Danish Cancer Society
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Performance status \>2 * liver metastases refereed for SBRT

Exclusion criteria

* pregnancy * claustrophobia

Design outcomes

Primary

MeasureTime frame
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 Gyup to 2 years

Secondary

MeasureTime frame
evaluate toxicity to SBRT by toxicity scoring system that includes biochemical measures as well as symptomatic scores.up to 2 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026