Hepatocellular CarcinomaPERCAHECNCT03754192
Perfusion and Dual Energy Computer Tomography in Hepatocellular Carcinoma
A study testing perfusion Computed Tomography in people with Hepatocellular Carcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this study is to evaluate the hepatic perfusion computer tomography and dual energy computer tomography in the assessment of tumor characterization of Hepatocellular carcinoma in patients with resectable Hepatocellular carcinoma by comparing the quantitative parameters computer tomography obtained with the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- perfusion Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2019to 30 Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- A diagnosis of Hepatocellular carcinoma made according to the guidelines of the American Association for the study of the Liver
- Affiliation to a national health insurance
- An indication for hepatic resection during the decision-making stage
- A request for a pre-operative Computer Tomography in our radiology unit
- An affiliation to a social security
- Informed consent given by the patient
Who cannot join
- Previous treatments of Hepatocellular carcinoma (medicated or surgical)
- Patient under tutorship or curatorship
- Pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
DA-MOTA-FERREIRA Jean-Manuel, Radiologic contact
France1 site, 1 recruiting
- Recruiting
CHU Paul Brousse
Villejuif, 94800
LEWIN MAITE, MD, PhD, 00 (33) 6 11 15 06 17, maite.lewin@aphp.fr
About this study
Official title: Prediction Value of Perfusion and Dual Energy Computer Tomography for Microvascular Invasion in Hepatocellular Carcinoma
The aim of this study is to evaluate the hepatic perfusion computer tomography and dual energy computer tomography in the assessment of tumor characterization of Hepatocellular carcinoma in patients with resectable Hepatocellular carcinoma by comparing the quantitative parameters computer tomography obtained with the pathological data of the surgical specimens.
Read the detailed description
Dual-energy computer tomography and perfusion computer tomography (General Electric revolution Hight definition Gemstone™ Spectral Imaging) will be performed in all patients. Iodine concentration and quantitative perfusion parameters of the Hepatocellular carcinoma and surrounding liver parenchyma data will be compared with the pathological results.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- perfusion Computed Tomography
- Keywords
- Perfusion computer tomography, dual-energy computer tomography
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perfusion Computed TomographyRadiation
Also called Computed tomography
Will be carried before liver surgery
| Study group | Role | What they receive |
|---|---|---|
| perfusion computed tomography | Other | Will be realsed before liver surgery Receives: Radiation: perfusion Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pefusion parameters
correlation between pre-operative imaging data and histological data of Hepatocellular carcinoma
Measured: 5 minutes
Secondary outcomes (1)
Pathological examination
Compare data obtained in perfusion computer tomography to the imaging data and to the Histological differentiation grades
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start30 Jan 2019
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
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 Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dual-energy computed tomography and perfusion computed tomography
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LEWIN MAITE, MD, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754192
- Sponsor's protocol ID
- APHP180011
- Acronym
- PERCAHEC
- Status last verified
- Aug 2020
- First submitted
- 14 Nov 2018
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lewin M, Laurent-Bellue A, Desterke C, Radu A, Feghali JA, Farah J, Agostini H, Nault JC, Vibert E, Guettier C. Evaluation of perfusion CT and dual-energy CT for predicting microvascular invasion of hepatocellular carcinoma. Abdom Radiol (NY). 2022 Jun;47(6):2115-2127. doi: 10.1007/s00261-022-03511-7. Epub 2022 Apr 13.
PubMed 35419748
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Value of Perfusion and Dual Energy Computer Tomography for Microvascular Invasion in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03754192
- Acronym / sponsor ID
- PERCAHEC / APHP180011
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Perfusion computer tomography, dual-energy computer tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 27 Nov 2018 (actual)
- 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 aim of this study is to evaluate the hepatic perfusion computer tomography and dual energy computer tomography in the assessment of tumor characterization of Hepatocellular carcinoma in patients with resectable Hepatocellular carcinoma by comparing the quantitative parameters computer tomography obtained with the pathological data of the surgical specimens.
Detailed description
Dual-energy computer tomography and perfusion computer tomography (General Electric revolution Hight definition Gemstone™ Spectral Imaging) will be performed in all patients. Iodine concentration and quantitative perfusion parameters of the Hepatocellular carcinoma and surrounding liver parenchyma data will be compared with the pathological results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dual-energy computed tomography and perfusion computed tomography
| Arm | Type | Receives |
|---|---|---|
| perfusion computed tomography | Other | Radiation: perfusion Computed TomographyWill be realsed before liver surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A diagnosis of Hepatocellular carcinoma made according to the guidelines of the American Association for the study of the Liver
- Affiliation to a national health insurance
- An indication for hepatic resection during the decision-making stage
- A request for a pre-operative Computer Tomography in our radiology unit
- An affiliation to a social security
Key exclusion criteria (3 listed)
- Previous treatments of Hepatocellular carcinoma (medicated or surgical)
- Patient under tutorship or curatorship
- Pregnant or lactating woman
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 |
|---|---|---|
| perfusion Computed TomographyAlso: Computed tomographyWill be carried before liver surgery | Radiation | perfusion computed tomography |
Primary outcome
Pefusion parameters
Time frame: 5 minutes
correlation between pre-operative imaging data and histological data of Hepatocellular carcinoma
1 secondary outcome
Pathological examination
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Derived from this study: PubMed 35419748Lewin M, Laurent-Bellue A, Desterke C, Radu A, Feghali JA, Farah J, Agostini H, Nault JC, Vibert E, Guettier C. Evaluation of perfusion CT and dual-energy CT for predicting microvascular invasion of hepatocellular carcinoma. Abdom Radiol (NY). 2022 Jun;47(6):2115-2127. doi: 10.1007/s00261-022-03511-7. Epub 2022 Apr 13.
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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.
DA-MOTA-FERREIRA Jean-Manuel, Radiologic contact
LEWIN MAITE, MD, PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perfusion Computed Tomography in people with Hepatocellular Carcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 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: status not confirmed, as of the sponsor's last update on 1 Sep 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LEWIN MAITE, MD, Phd (00 (33) 6 11 15 06 17, maite.lewin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pefusion parameters (time frame: 5 minutes). 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 NCT03754192, 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 Sep 2020.