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Completed

NCT Number: NCT01116804

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

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).

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Key information

Conditions

Primary Liver Cancer Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Ghent

Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI of the liver before start of treatment

Procedure

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

MRI after treatment

Procedure

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

PET-scan before treatment start

Procedure

PET-scan with 2 tracers is performed before treatment start

PET scan after treatment

Procedure

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
May 5, 2010
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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