Role PET Imaging in Response Assessment for Hepatocellular Carcinoma (HCC)
1 other identifier
interventional
36
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2010
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2010
CompletedFirst Posted
Study publicly available on registry
May 5, 2010
CompletedStudy Start
First participant enrolled
June 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2020
CompletedDecember 15, 2022
December 1, 2022
9.6 years
May 3, 2010
December 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy of PET-imaging versus classic response assessment (MRI, CT-scam) in patients with inoperable liver cancer
6 months after start of treatment
Study Arms (1)
inoperable liver cancer patients
OTHERInterventions
MRI of the liver as classic work out of patients (CT-scan if MRI is contra-indicated)
MRI of the liver after 3 - 6 months of treatment (CT-scan if MRI is contra-indicated)
PET-scan with 2 tracers is performed before treatment start
PET-scan with 2 tracers is repeated 4 weeks following start of treatment
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- University Ghentcollaborator
Study Sites (1)
University Hospital Ghent
Ghent, Belgium
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bieke Lambert, MD
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2010
First Posted
May 5, 2010
Study Start
June 16, 2010
Primary Completion
January 20, 2020
Study Completion
January 20, 2020
Last Updated
December 15, 2022
Record last verified: 2022-12