HCCNCT02977754
18F-FDG PET in HCC Patients Candidate to Treatment With Sorafenib
An observational study of HCC, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
The principal objective of this study is to explore the role of 18F-FDG PET in identifying sorafenib-induced metabolic shift in HCC, thus in predicting treatment response and disease outcome in advanced HCC patients candidate to systemic treatment with sorafenib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC
- What is being tested?
- This is an observational study
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a single-center, single-arm study, lasting 36 months including an estimated period of 24 months for the enrolment and max 12 months of follow-up. All patients affected by HCC and referred to our Institution for systemic treatment with sorafenib will be evaluated for enrolment. A minimum number of 10 patients will be considered for the analysis.
Who may be able to join
- patients with an histological diagnosis of HCC and scheduled to undergo systemic treatment with sorafenib;
- obtained informed consent
Who cannot join
- patients age <18 years
- pregnancy or breast-feeding;
- patients affected by other malignancies within the last 3 years, with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Prognostic Role of 18F-FDG PET/CT Imaging in Patients Affected by Hepatocellular Carcinoma (HCC) and Candidate to Treatment With Sorafenib
The principal objective of this study is to explore the role of 18F-FDG PET in identifying sorafenib-induced metabolic shift in HCC, thus in predicting treatment response and disease outcome in advanced HCC patients candidate to systemic treatment with sorafenib.
Read the detailed description
Aerobic glycolysis also called "Warburg effect", represents one of the distinctive hallmarks of the malignant cells. Although energetically less efficient than respiration, fermentative metabolism is advantageous for cell growth due to the increased availability of anabolic intermediates and the reduced cell dependence on oxygen. Moreover, by increasing intracellular reducing equivalents and decreasing mitochondria-derived ROS, glycolysis protects malignant cells from oxidant-induced senescence and apoptosis.
In diagnostic imaging, the "Warburg effect" is visualized thanks to the utilization of fluoro-2-deoxyglucose, a glucose analogue, labeled with the positron emitting nuclide fluoride-18 (18F). F-2-fluoro-2-deoxyglucose (18F-FDG) with positron emission tomography (PET) has emerged useful in many tumor types and in HCC can help ruling out extra-hepatic metastases or sites of recurrent disease, and giving prognostic information. Considering the abovementioned premises, the investigators hypothesize a potential use of 18F-FDG PET for the early assessment of sorafenib-induced metabolic shift in HCC, especially in well-differentiated subtypes usually showing an uptake of the tracer not different or at least not sufficiently increased compared to the normal liver.
For these reasons the investigators decided to conduct an explorative study for the assessment of predictive and prognostic role of 18F-FDG PET in patients affected by advanced HCC and candidate to systemic treatment with sorafenib.
The principal objective of this study is to explore the role of 18F-FDG PET in identifying sorafenib-induced metabolic shift in HCC, thus in predicting treatment response and disease outcome in advanced HCC patients candidate to systemic treatment with sorafenib.
More specifically the investigators will:
- compare 18F-FDG uptake in HCC lesions, identified as target lesions (diam. min. 2cm), at baseline, at 24 hours and 1 week after the first administration of sorafenib.
- correlate the patterns of 18F-FDG uptake in HCC lesions with objective tumor response assessed 8 weeks after the first administration of sorafenib according to mRECIST criteria.
- correlate the patterns of 18F-FDG uptake in HCC lesions with alpha-fetoprotein (AFP) variation at baseline, at 24 hours and 1 week after the first administration of sorafenib.
- correlate the patterns of 18F-FDG uptake in HCC lesions with progression-free survival (PFS) and overall survival (OS).
- Conditions
- HCC
- Being tested
- This is an observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational studyOther
Imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Early change of metabolic characteristics (i.e. SUVmax, SUVmean, MTV, TLG) of HCC lesions under Sorafenib
Baseline parameters
Measured: Compare 18F-FDG uptake in HCC lesions at baseline and at 24 hours after the first administration of sorafenib.
Secondary outcomes (3)
Change of metabolic characteristics (i.e. SUVmax, SUVmean, MTV, TLG) of HCC lesions under Sorafenib
Variation of parameters
Measured: Compare 18F-FDG uptake in HCC lesions at baseline and 1 week after the first administration of sorafenib.
Predictive role of metabolic characteristics of HCC (i.e. SUVmax, SUVmean, MTV, TLG) lesions under Sorafenib
PET scan parameters compared to response
Measured: Correlate the patterns of 18F-FDG uptake in HCC lesions with objective tumor response assessed 8 weeks after the first administration of sorafenib according to mRECIST criteria
Prognostic role of metabolic characteristics (i.e. SUVmax, SUVmean, MTV, TLG) of HCC lesions under Sorafenib
PET scan parameters compared to outcome
Measured: Correlate the patterns of 18F-FDG uptake in HCC lesions with progression-free survival (PFS) and overall survival (OS) assessed during a minimun of 12 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Egesta Lopci, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977754
- Sponsor's protocol ID
- 1458
- Status last verified
- Sep 2020
- First submitted
- 18 Nov 2016
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Castello A, Rimassa L, Personeni N, Pressiani T, Smiroldo V, Lopci E. Metabolic Switch in Hepatocellular Carcinoma Patients Treated with Sorafenib: a Proof-of-Concept Trial. Mol Imaging Biol. 2020 Oct;22(5):1446-1454. doi: 10.1007/s11307-020-01489-6.
PubMed 32206991
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Prognostic Role of 18F-FDG PET/CT Imaging in Patients Affected by Hepatocellular Carcinoma (HCC) and Candidate to Treatment With Sorafenib
- ClinicalTrials.gov ID
- NCT02977754
- Acronym / sponsor ID
- 1458
- Conditions
- HCC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The principal objective of this study is to explore the role of 18F-FDG PET in identifying sorafenib-induced metabolic shift in HCC, thus in predicting treatment response and disease outcome in advanced HCC patients candidate to systemic treatment with sorafenib.
Detailed description
Aerobic glycolysis also called "Warburg effect", represents one of the distinctive hallmarks of the malignant cells. Although energetically less efficient than respiration, fermentative metabolism is advantageous for cell growth due to the increased availability of anabolic intermediates and the reduced cell dependence on oxygen. Moreover, by increasing intracellular reducing equivalents and decreasing mitochondria-derived ROS, glycolysis protects malignant cells from oxidant-induced senescence and apoptosis.
In diagnostic imaging, the "Warburg effect" is visualized thanks to the utilization of fluoro-2-deoxyglucose, a glucose analogue, labeled with the positron emitting nuclide fluoride-18 (18F). F-2-fluoro-2-deoxyglucose (18F-FDG) with positron emission tomography (PET) has emerged useful in many tumor types and in HCC can help ruling out extra-hepatic metastases or sites of recurrent disease, and giving prognostic information. Considering the abovementioned premises, the investigators hypothesize a potential use of 18F-FDG PET for the early assessment of sorafenib-induced metabolic shift in HCC, especially in well-differentiated subtypes usually showing an uptake of the tracer not different or at least not sufficiently increased compared to the normal liver.
For these reasons the investigators decided to conduct an explorative study for the assessment of predictive and prognostic role of 18F-FDG PET in patients affected by advanced HCC and candidate to systemic treatment with sorafenib.
The principal objective of this study is to explore the role of 18F-FDG PET in identifying sorafenib-induced metabolic shift in HCC, thus in predicting treatment response and disease outcome in advanced HCC patients candidate to systemic treatment with sorafenib.
More specifically the investigators will:
- compare 18F-FDG uptake in HCC lesions, identified as target lesions (diam. min. 2cm), at baseline, at 24 hours and 1 week after the first administration of sorafenib.
- correlate the patterns of 18F-FDG uptake in HCC lesions with objective tumor response assessed 8 weeks after the first administration of sorafenib according to mRECIST criteria.
- correlate the patterns of 18F-FDG uptake in HCC lesions with alpha-fetoprotein (AFP) variation at baseline, at 24 hours and 1 week after the first administration of sorafenib.
- correlate the patterns of 18F-FDG uptake in HCC lesions with progression-free survival (PFS) and overall survival (OS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a single-center, single-arm study, lasting 36 months including an estimated period of 24 months for the enrolment and max 12 months of follow-up. All patients affected by HCC and referred to our Institution for systemic treatment with sorafenib will be evaluated for enrolment. A minimum number of 10 patients will be considered for the analysis.
Key inclusion criteria (2 listed)
- patients with an histological diagnosis of HCC and scheduled to undergo systemic treatment with sorafenib;
- obtained informed consent
Key exclusion criteria (3 listed)
- patients age <18 years
- pregnancy or breast-feeding;
- patients affected by other malignancies within the last 3 years, with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is an observational studyImaging | Other | – |
Primary outcome
Early change of metabolic characteristics (i.e. SUVmax, SUVmean, MTV, TLG) of HCC lesions under Sorafenib
Time frame: Compare 18F-FDG uptake in HCC lesions at baseline and at 24 hours after the first administration of sorafenib.
Baseline parameters
3 secondary outcomes
Change of metabolic characteristics (i.e. SUVmax, SUVmean, MTV, TLG) of HCC lesions under Sorafenib
Time frame: Compare 18F-FDG uptake in HCC lesions at baseline and 1 week after the first administration of sorafenib.
Predictive role of metabolic characteristics of HCC (i.e. SUVmax, SUVmean, MTV, TLG) lesions under Sorafenib
Time frame: Correlate the patterns of 18F-FDG uptake in HCC lesions with objective tumor response assessed 8 weeks after the first administration of sorafenib according to mRECIST criteria
Prognostic role of metabolic characteristics (i.e. SUVmax, SUVmean, MTV, TLG) of HCC lesions under Sorafenib
Time frame: Correlate the patterns of 18F-FDG uptake in HCC lesions with progression-free survival (PFS) and overall survival (OS) assessed during a minimun of 12 months of follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Background: PubMed 32206991Castello A, Rimassa L, Personeni N, Pressiani T, Smiroldo V, Lopci E. Metabolic Switch in Hepatocellular Carcinoma Patients Treated with Sorafenib: a Proof-of-Concept Trial. Mol Imaging Biol. 2020 Oct;22(5):1446-1454. doi: 10.1007/s11307-020-01489-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Egesta Lopci principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early change of metabolic characteristics (i.e. SUVmax, SUVmean, MTV, TLG) of HCC lesions under Sorafenib (time frame: Compare 18F-FDG uptake in HCC lesions at baseline and at 24 hours after the first administration of sorafenib.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02977754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.