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

NCT ID: NCT01116804

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-16

Study Completion Date

2020-01-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Liver Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Primary liver cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

inoperable liver cancer patients

Group Type OTHER

MRI of the liver before start of treatment

Intervention Type PROCEDURE

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

MRI after treatment

Intervention Type PROCEDURE

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

PET-scan before treatment start

Intervention Type PROCEDURE

PET-scan with 2 tracers is performed before treatment start

PET scan after treatment

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type PROCEDURE

MRI after treatment

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

Intervention Type PROCEDURE

PET-scan before treatment start

PET-scan with 2 tracers is performed before treatment start

Intervention Type PROCEDURE

PET scan after treatment

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Ghent

OTHER

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bieke Lambert, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Related Links

Access external resources that provide additional context or updates about the study.

http://www.uzgent.be

website University Hospital Ghent

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010/115

Identifier Type: -

Identifier Source: org_study_id