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NCT01861873 Clinical Trial

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

Liver Metastases Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01861873
Other study ID # 210982
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received May 15, 2013
Last updated May 21, 2013
Start date August 2013
Est. completion date March 2016

Study information
Verified date May 2013
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Interventional

Clinical 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 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 28
Est. completion date March 2016
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Performance status >2

- liver metastases refereed for SBRT

Exclusion Criteria:

- pregnancy

- claustrophobia

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• measuring liver function by 18-FDGal PET/CT

Locations
Country Name City State
Denmark Aarhus University Hospital Aarhus C

Sponsors (2)
Lead Sponsor Collaborator
University of Aarhus Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary evaluate toxicity to SBRT by toxicity scoring system that includes biochemical measures as well as symptomatic scores. up to 2 years No
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