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NCT01116804 Clinical Trial

Role PET Imaging in Response Assessment for Hepatocellular Carcinoma (HCC)

Primary Liver Cancer Clinical Trial

Official title:
Role PET Imaging in Response Assessment for Hepatocellular Carcinoma (HCC)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01116804
Other study ID # 2010/115
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 16, 2010
Est. completion date January 20, 2020

Study information
Verified date December 2022
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date January 20, 2020
Est. primary completion date January 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• MRI of the liver before start of treatment
MRI of the liver as classic work out of patients (CT-scan if MRI is contra-indicated)
• MRI after treatment
MRI of the liver after 3 - 6 months of treatment (CT-scan if MRI is contra-indicated)
• PET-scan before treatment start
PET-scan with 2 tracers is performed before treatment start
• PET scan after treatment
PET-scan with 2 tracers is repeated 4 weeks following start of treatment

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Ghent University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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