Changes in Liver Function After Stereotactic Body Radiation Therapy Measured by PET/CT

Hepatocellular Carcinoma Clinical Trial

Official title:

Radiation Induced Change of Liver Function Measured by Uptake of the Galactose Analogue FDGal and PET/CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213758
• Other study ID #: AarhusLiverRadGal
• Status: Completed
• Phase: N/A
• First received: October 1, 2010
• Last updated: October 27, 2017
• Start date: June 2010
• Est. completion date: April 2016

Study information

• Verified date: October 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients treated with stereotactic radiotherapy for liver tumors undergo PET/CT using the galactose analogue 18-F-deoxy-galactose (FDGal) before and after radiotherapy. This technique provides volumetric mapping of liver function and it allows quantisation of liver function. The method may be used for selection of patients for stereotactic radiotherapy of liver tumors, for determination of radiation induced liver dysfunction and may be included into the treatment planning process of stereotactic radiotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• liver tumor

• referred for stereotactic radiation therapy

• age > 18 years

Exclusion Criteria:

• Impaired kidney function

• Pregnancy

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Hepatocellular Carcinoma
• Metastases
• Stereotactic Body Radiotherapy

Intervention

Other:
• Measuring liver function by PET/CT
Measuring liver function by use of FDGal and PET/CT before, 1 month and 3 months after stereotactic radiotherapy for liver tumors

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	Uptake of FDGal	Volumetric uptake of FDGal can be measured is measured by PET/CT	Before, 1 month and 3 months after stereotactic radiotherapy

External Links

•   The Lundbeck Foundation Centre for Interventional Research in Radiation Oncology