NCT01861873

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 24, 2013

Status Verified

May 1, 2013

Enrollment Period

1.3 years

First QC Date

May 15, 2013

Last Update Submit

May 21, 2013

Conditions

Liver Metastases

Keywords

liver functiongalactose18-F-deoxy-galactose

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • evaluate toxicity to SBRT by toxicity scoring system that includes biochemical measures as well as symptomatic scores.

    up to 2 years

Study Arms (1)

liver metastases

OTHER

measuring liver function by PET/CT at patients where SBRT is planned for liver metastases

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

Interventions

measuring liver function by 18-FDGal PET/CTOTHER
liver metastases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnancy
  • claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2013

First Posted

May 24, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2014

Study Completion

March 1, 2016

Last Updated

May 24, 2013

Record last verified: 2013-05

Locations

DK(1)