Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
NCT ID:
NCT02847468
Eligibility Criteria:
Inclusion Criteria:
* Patient older than 18 years
* Inoperable (advanced or metastatic) HCC histologically proven, or diagnosed according to the Barcelona criteria, determined to be candidate for Sorafenib therapy
* Lesion(s) able to be selected as targeted lesion(s) for modified RECIST criteria
* patient ineligible for curative treatment
* Child-Pugh liver function (platelet count superior or equal to 60X1 000 000 000per liter; haemoglobin superior or equal to 8,5g/dl
* Performance status more or equal to 2
* Able to lie still for 45min for PET/CT scanning
* Able to understand and willing to signa written informed consent document
* Affiliated to the French social security social or beneficiary to such a regimen
Exclusion Criteria:
* Uncontrolled intercurrent illness with short-term life-threatening
* Pregnant or nursing woman
* Patient candidate to local/curative therapy of HCC (surgery, radiofrequency, transarterial chemoembolization, other local therapy).
* History of myocardial infarction less than 6 months before inclusion, uncontrolled hypertension, symptomatic congestive heart failure, anti-arrhythmic therapy (other than beta-blockers or digoxine)
* History of digestive bleeding less than 30 days before inclusion
* history of liver transplantation
* Previous treatment including Sorafenib Uncontrolled diabetes History of allergic reactions attributed to compounds of similar chemical or biologic composition to Fluorocholine, 18F-Fluorodeoxyglucose or Sorafenib
* Psychiatric illness/social situations that would limit compliance with the study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02847468
Study Brief:
Protocol Section:
NCT02847468