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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01116804

Enrollment

Registered

2010-05-05

Start date

2010-06-16

Completion date

2020-01-20

Last updated

2022-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Liver Cancer

Keywords

Primary liver cancer

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).

Interventions

PROCEDUREMRI of the liver before start of treatment

MRI of the liver as classic work out of patients (CT-scan if MRI is contra-indicated)

PROCEDUREMRI after treatment

MRI of the liver after 3 - 6 months of treatment (CT-scan if MRI is contra-indicated)

PROCEDUREPET-scan before treatment start

PET-scan with 2 tracers is performed before treatment start

PROCEDUREPET scan after treatment

PET-scan with 2 tracers is repeated 4 weeks following start of treatment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026