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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
University Ghent
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01116804
First received: May 3, 2010
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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).


Condition Intervention Phase
Primary Liver Cancer
Procedure: MRI of the liver before start of treatment
Procedure: MRI after treatment
Procedure: PET-scan before treatment start
Procedure: PET scan after treatment
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Role PET Imaging in Response Assessment for Hepatocellular Carcinoma (HCC)

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: May 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
inoperable liver cancer patients 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)
Procedure: MRI after treatment
MRI of the liver after 3 - 6 months of treatment (CT-scan if MRI is contra-indicated)
Procedure: PET-scan before treatment start
PET-scan with 2 tracers is performed before treatment start
Procedure: PET scan after treatment
PET-scan with 2 tracers is repeated 4 weeks following start of treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116804

Contacts
Contact: Bieke Lambert, MD bieke.lambert@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium
Principal Investigator: Bieke Lambert, MD         
Sub-Investigator: H. Van Vlierberghe, MD, PhD         
Sub-Investigator: R. Troisi, MD, PhD         
Sub-Investigator: L. Defreyne, MD, PhD         
Sub-Investigator: P. Smeets, MD         
Sponsors and Collaborators
University Hospital, Ghent
University Ghent
Investigators
Principal Investigator: Bieke Lambert, MD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01116804     History of Changes
Other Study ID Numbers: 2010/115
Study First Received: May 3, 2010
Last Updated: February 1, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Primary liver cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2014