Role PET Imaging in Response Assessment for Hepatocellular Carcinoma (HCC)
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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) |
- 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 |
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| Contact: Bieke Lambert, MD | bieke.lambert@ugent.be |
| 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 | |
| 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 Liver Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Adenocarcinoma |
ClinicalTrials.gov processed this record on May 22, 2013