Role PET Imaging in Response Assessment for Hepatocellular Carcinoma (HCC)
Primary Purpose
Primary Liver Cancer
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
MRI of the liver before start of treatment
MRI after treatment
PET-scan before treatment start
PET scan after treatment
Sponsored by
About this trial
This is an interventional diagnostic trial for Primary Liver Cancer focused on measuring Primary liver cancer
Eligibility Criteria
Inclusion Criteria :
Male and female are eligible
->18years of age.No upper age limit.
- not pregnant or breastfeeding
- capable of understanding the study goals and protocol and to sign the informed consent.
- Patients are diagnosed with primary liver cancer and referred for treatment with biologicals such as Sorafenib or treatment with radionuclides.
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
inoperable liver cancer patients
Arm Description
Outcomes
Primary Outcome Measures
To evaluate the efficacy of PET-imaging versus classic response assessment (MRI, CT-scam) in patients with inoperable liver cancer
Secondary Outcome Measures
Full Information
NCT ID
NCT01116804
First Posted
May 3, 2010
Last Updated
December 13, 2022
Sponsor
University Hospital, Ghent
Collaborators
University Ghent
1. Study Identification
Unique Protocol Identification Number
NCT01116804
Brief Title
Role PET Imaging in Response Assessment for Hepatocellular Carcinoma (HCC)
Official Title
Role PET Imaging in Response Assessment for Hepatocellular Carcinoma (HCC)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 16, 2010 (Actual)
Primary Completion Date
January 20, 2020 (Actual)
Study Completion Date
January 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
University Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Present imaging modalities for primary liver cancer (hepatocellular carcinoma or HCC) have several shortcomings. One important shortcoming is the time delay between successful treatment and radiological confirmation of this response. Often it takes several months for anatomical changes to occur and to be appreciated on morphological imaging such as CT or MRI (shrinkage of tumor, absence of contrast enhancement). Functional imaging by means of Fluor-18 deoxyglucose or Fluor-18 Choline (positron emitters, PET-scan) might be an early indicator of response. This "early" information might help to tailor treatment. For instance, if no response is induced, an early switch in therapy can be planned.
The present study investigates whether the routine PET-tracer (Fluor-18 deoxyglucose) and the experimental PET-tracer, Fluor-18 Choline help to predict response if a patient with inoperable primary liver cancer is treated (radionuclide therapy, biologicals).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Liver Cancer
Keywords
Primary liver cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
inoperable liver cancer patients
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
MRI of the liver before start of treatment
Intervention Description
MRI of the liver as classic work out of patients (CT-scan if MRI is contra-indicated)
Intervention Type
Procedure
Intervention Name(s)
MRI after treatment
Intervention Description
MRI of the liver after 3 - 6 months of treatment (CT-scan if MRI is contra-indicated)
Intervention Type
Procedure
Intervention Name(s)
PET-scan before treatment start
Intervention Description
PET-scan with 2 tracers is performed before treatment start
Intervention Type
Procedure
Intervention Name(s)
PET scan after treatment
Intervention Description
PET-scan with 2 tracers is repeated 4 weeks following start of treatment
Primary Outcome Measure Information:
Title
To evaluate the efficacy of PET-imaging versus classic response assessment (MRI, CT-scam) in patients with inoperable liver cancer
Time Frame
6 months after start of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria :
Male and female are eligible
->18years of age.No upper age limit.
not pregnant or breastfeeding
capable of understanding the study goals and protocol and to sign the informed consent.
Patients are diagnosed with primary liver cancer and referred for treatment with biologicals such as Sorafenib or treatment with radionuclides.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bieke Lambert, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
website University Hospital Ghent
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Role PET Imaging in Response Assessment for Hepatocellular Carcinoma (HCC)
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