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

Phase 2

• Conditions: Liver Metastases
• Interventions: Other: measuring liver function by 18-FDGal PET/CT

• Registration Number: NCT01861873
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2013-05
• Study First Submitted: 2013-05-15
• Study First Submitted QC: 2013-05-21
• Last Update Submitted: 2013-05-21
• Study First Posted: 2013-05-24
• Last Update Posted: 2013-05-24
• Study Start: 2013-08
• Primary Completion: 2014-12
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Performance status >2
• liver metastases refereed for SBRT

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Exclusion Criteria

• pregnancy
• claustrophobia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
liver metastases	measuring liver function by 18-FDGal PET/CT	measuring liver function by PET/CT at patients where SBRT is planned for liver metastases

Primary Outcome Measures

Name	Time	Method
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	up to 2 years

Secondary Outcome Measures

Name	Time	Method
evaluate toxicity to SBRT by toxicity scoring system that includes biochemical measures as well as symptomatic scores.	up to 2 years

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus C, Denmark