search
Back to results

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

Primary Purpose

Liver Metastases

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
measuring liver function by 18-FDGal PET/CT
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Metastases focused on measuring liver function, galactose, 18-F-deoxy-galactose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Performance status >2
  • liver metastases refereed for SBRT

Exclusion Criteria:

  • pregnancy
  • claustrophobia

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

liver metastases

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 15, 2013
Last Updated
May 21, 2013
Sponsor
University of Aarhus
Collaborators
Danish Cancer Society
search

1. Study Identification

Unique Protocol Identification Number
NCT01861873
Brief Title
Functional Treatment Planning Utilizing 18-FDGal PET/CT in SBRT for Liver Metastases
Official Title
Phase 2 Study: Functional Treatment Planning Utilizing 18-FDGal PET/CT in SBRT for Liver Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Danish Cancer Society

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastases
Keywords
liver function, galactose, 18-F-deoxy-galactose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
liver metastases
Arm Type
Other
Arm Description
measuring liver function by PET/CT at patients where SBRT is planned for liver metastases
Intervention Type
Other
Intervention Name(s)
measuring liver function by 18-FDGal PET/CT
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
evaluate toxicity to SBRT by toxicity scoring system that includes biochemical measures as well as symptomatic scores.
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Performance status >2 liver metastases refereed for SBRT Exclusion Criteria: pregnancy claustrophobia
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mette Marie Fode, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs