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

NCT ID: NCT01861873

Last Updated: 2013-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-03-31

Brief Summary

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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

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Conditions

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Liver Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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liver metastases

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

Group Type OTHER

measuring liver function by 18-FDGal PET/CT

Intervention Type OTHER

Interventions

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measuring liver function by 18-FDGal PET/CT

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnancy
* claustrophobia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Cancer Society

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aarhus University Hospital

Aarhus C, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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210982

Identifier Type: -

Identifier Source: org_study_id

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