NCT01157013

Brief Summary

Positron emission tomography (PET) with \[18F\]fluorodeoxyglucose (FDG-PET) evaluates cancer cell glycolysis(Warburg effect) as a surrogate for tumor response.The hypothesis of this study is that early changes in FDG-PET signal can predict sorafenib response in hepatocellular carcinoma (HCC).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Jan 2009

Shorter than P25 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2010

Completed
Last Updated

July 5, 2010

Status Verified

July 1, 2010

Enrollment Period

1.4 years

First QC Date

July 2, 2010

Last Update Submit

July 2, 2010

Conditions

Hepatocellular Carcinoma

Keywords

Positron Emission TomographyHepatocellular carcinomaLiver CancerSorafenibResponse Evaluation

Outcome Measures

Primary Outcomes (1)

  • Response to sorafenib therapy shown in PET Scans

    Changes in the SUVmax during treatment (SUVmax) were determined by the following equation: (post-treatment SUVmax - baseline SUVmax)/baseline SUVmax, expressed in percentage. The SUVmax for all target lesions were averaged(mSUVmax) and reported per the 1999 European Organisation for Research and Treatment of Cancer recommendations.

    Baseline and after three weeks on treatment

Secondary Outcomes (1)

  • Tumor response evaluated by CT and MRI

    Basal and every two months

Study Arms (1)

Advanced Hepatocellular Carcinoma

EXPERIMENTAL

Hepatocellular carcinoma patients not candidates to local and/or curative treatment and an expected overall survival of at least three months and who are susceptible of receiving sorafenib therapy.

Other: Positron emission tomography with fludeoxyglucose F 18

Interventions

Positron emission tomography with fludeoxyglucose F 18OTHER

Patients receive fludeoxyglucose F 18 (\^18FDG) IV. Beginning 1 hour later, patients undergo whole-body positron emission tomography (PET) scanning. Patients also undergo conventional radiographic staging of their disease.

Also known as: PET
Advanced Hepatocellular Carcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • advanced hepatocellular carcinoma: diagnostic assessment by biopsy/cytology; in cirrhotic patients conventional radiologic criteria are also accepted
  • more than 18 years of age.
  • life expectancy greater than three months
  • candidate to sorafenib therapy
  • informed consent required

You may not qualify if:

  • hepatocellular carcinoma patients candidate to local/curative therapies(surgery/radiofrequency/TACE/other local therapy
  • another active cancer than primary liver cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miguel Servet University Hospital

Zaragoza, Aragon, 50009, Spain

Location

Related Links

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Interventions

Magnetic Resonance SpectroscopyFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesDeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Roberto A. Pazo Cid, MD

    Aragon Health Institute. Hospital Miguel Servet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 2, 2010

First Posted

July 5, 2010

Study Start

January 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 5, 2010

Record last verified: 2010-07

Locations

ES(1)