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Combination PET With 18F-fluorodeoxyglucose (18F-FDG) and 18 F-choline in Patient With HCC (PET-HCC01)

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PET-TDM with 18F-FDG + PET-TDM with 18F-fluorocholine
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring Positron Emission Tomography, 18F-FDG, 18 F-Fluorocholine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients> 18 years old
  • First diagnosis of HCC (no previous treatments received)
  • Diagnosis of HCC according to The European Association for the Study of the Liver (EASL) 2012 criteria by "non-invasive" imaging on cirrhosis or by histology on cirrhosis or non-cirrhotic liver
  • BCLC tumor stage A to C (excluding BCLC C with extrahepatic metastases) according to conventional imaging
  • Will be able to have a PET scanner within 4 weeks after the inclusion visit
  • Ability to stay 20 minutes longer for PET-CT scans
  • Need for oral, intra-uterine or mechanical contraception for women of childbearing age
  • Written consent for participation in the study
  • Having medical insurance coverage

Exclusion Criteria:

  • Patients classified BCLC stage 0 (single HCC less than 2 cm)
  • Patients classified as BCLC stage C with extrahepatic metastases
  • Decreased cirrhosis (Child Pugh C) and / or patients with Eastern Cooperative Oncology Group (ECOG) Performance Status 2 to 4 not candidates for liver transplantation
  • Uncontrolled diabetes (defined by blood glucose> 1.7 g / L at the time of inclusion)
  • Hypersensitivity to 18F Fluorocholine or 18F-FDG or any of the excipients
  • Creatinine clearance <40 mL / min
  • Contraindication to MRI: pacemaker or implantable cardiac defibrillator not compatible with MRI, neurostimulator, cochlear implant, intracerebral ferromagnetic vascular clip, intraocular or cerebral metallic foreign bodies, insulin pump
  • Pregnant or lactating woman
  • Patient under tutorship or curatorship or safeguard of justice
  • Known allergy to iodine
  • Patient deprived of liberty by judicial or administrative decision
  • Patients with care "State Medical Aid"

Sites / Locations

  • NAULTRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET-TDM

Arm Description

PET-TDM with 18F-FDG and PET-TDM with 18F-fluorocholine

Outcomes

Primary Outcome Measures

Demonstrate that the identification of new tumour lesions by an experimental procedure combining PET-TDMs with 18F-FDG and 18F-Fluorocholine in patients with HCC modifies the initially planned therapeutic strategy
The primary objective of the study will be evaluated by the proportion of patients with a first diagnosis of HCC whose treatment initially planned in a multidisciplinary consultation meeting is modified by the combined use of PET-TDMs at 18F-FDG and 18F-Fluorocholine in combination with conventional imaging compared to conventional imaging alone.

Secondary Outcome Measures

Number of patients for whom a curative treatment initially planned on the basis of conventional imaging has been modified, for a loco-regional or systemic palliative treatment by the experimental procedure (18F-FDG and 18F PET-CTs) -Fluorocholine)
The proportion of patients for whom curative treatment initially planned on the basis of conventional imaging has been modified for loco-regional or systemic palliative treatment by the experimental procedure (PET-TDMs at 18F-FDG and 18F-Fluorocholine).
Modification of the BCLC tumor stage initially evaluated by conventional imaging on the basis of each PET-TDM (18F-FDG alone, 18F-Fluorocholine alone) separately and then the combination of both (combination of PET-TDMs with 18F-FDG and 18F-Fluorocholine
The proportion of modification of the tumor status to a more advanced status in the BCLC classification using PET/CT using 18F-FDG alone, 18F-Fluorocholine alone and then the combination of both in association with conventional imaging compared to conventional imaging alone
Identification as a HCC of at least one additional tumour lesion using the experimental procedure (each PET-TDM separately and then the combination of both) compared to conventional imaging alone
The proportion of patients with an additional tumor lesion detected by 18F-FDG-PET alone, with 18F-Fluorocholine alone and then the combination of both, whose tumor nature is confirmed histologically or by imaging follow-up
Description of the differences in diagnostic performance of the experimental procedure compared to the diagnostic gold standard (non-invasive criteria and/or tumor histology)
The proportion of new intrahepatic and/or extrahepatic lesions detected by PET-TDMs at 18F-FDG and 18F-Fluorocholine and confirmed as HCC on histology or by imaging follow-up
Cost-effectiveness between PET-TDMs at 18F-FDG and 18F-Fluorocholine associated with conventional imaging versus conventional imaging alone
The (incremental) cost-effectiveness ratio of 18F-FDG and 18F-Fluorocholine PET-CTs associated with conventional imaging versus conventional imaging alone
Number of patients who had an additional examination proposed by the MCM (multidisciplinary consultation meeting) following the PET-TDMs performed
The number of patients who have had an additional complementary examination (biopsy or new imaging for example) proposed by the MCM following 18F-FDG and 18F-Fluorocholine PET-CT scans will be collected prospectively

Full Information

First Posted
May 4, 2020
Last Updated
June 27, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT04391348
Brief Title
Combination PET With 18F-fluorodeoxyglucose (18F-FDG) and 18 F-choline in Patient With HCC
Acronym
PET-HCC01
Official Title
Prospective Study Evaluating the Combination of Positron Emission Tomography (PET) With 18F-FDG and 18 F-Fluorocholine for Optimization of Staging and Treatment Modification in Patients With Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this protocol is to obtain a better match between the actual staging and the proposed treatment in order to avoid inadequate treatments at risk of complications. In patients with HCC classified as BCLC A to C, the combination of 18F-FDG and 18F-Fluorocholine PET- TomoDensitoMetry (TDM) with conventional imaging would clinically significantly modify the therapeutic strategy initially planned by conventional imaging alone. This change in therapeutic strategy would be from curative to palliative treatment or from loco-regional palliative to systemic palliative treatment. 18F-FDG and 18F-Fluorocholine PET-CT scans will be performed after inclusion of the patient in the study and prior to multidisciplinary consultation meeting for treatment discussion.
Detailed Description
Hepatocellular carcinoma (HCC) is one of the leading causes of death from cancer worldwide, developing on cirrhosis in 90% of cases. The prognosis of patients with HCC remains poor with an overall survival of around 10% at 5 years for all tumor stages combined. The diagnosis of HCC relies on non-invasive conventional imaging criteria (computed tomography [CT] and/or magnetic resonance imaging [MRI]) and/or histology. Conventional imaging (liver CT and/or MRI and lung CT) enables HCC staging according to the Barcelona Clinical Liver Cancer (BCLC) system, linking each stage to therapeutic modalities. Accurate staging with reliable imaging methods is therefore crucial to determine the best treatment strategy. The principal objective is to demonstrate that the identification of new tumor lesions by an experimental procedure combining 18F-FDG and 18F-Fluorocholine PET-CT scans in patients with HCC, modifies the initially planned therapeutic strategy of a curative treatment palliative treatment, from locoregional palliative treatment to systemic palliative treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Positron Emission Tomography, 18F-FDG, 18 F-Fluorocholine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PET-TDM
Arm Type
Experimental
Arm Description
PET-TDM with 18F-FDG and PET-TDM with 18F-fluorocholine
Intervention Type
Radiation
Intervention Name(s)
PET-TDM with 18F-FDG + PET-TDM with 18F-fluorocholine
Intervention Description
Experimental procedure combining PET-TDM with 18F-FDG and PET-TDM with 18F-Fluorocholine
Primary Outcome Measure Information:
Title
Demonstrate that the identification of new tumour lesions by an experimental procedure combining PET-TDMs with 18F-FDG and 18F-Fluorocholine in patients with HCC modifies the initially planned therapeutic strategy
Description
The primary objective of the study will be evaluated by the proportion of patients with a first diagnosis of HCC whose treatment initially planned in a multidisciplinary consultation meeting is modified by the combined use of PET-TDMs at 18F-FDG and 18F-Fluorocholine in combination with conventional imaging compared to conventional imaging alone.
Time Frame
through multidisciplinary concertation meeting an average of 3 days
Secondary Outcome Measure Information:
Title
Number of patients for whom a curative treatment initially planned on the basis of conventional imaging has been modified, for a loco-regional or systemic palliative treatment by the experimental procedure (18F-FDG and 18F PET-CTs) -Fluorocholine)
Description
The proportion of patients for whom curative treatment initially planned on the basis of conventional imaging has been modified for loco-regional or systemic palliative treatment by the experimental procedure (PET-TDMs at 18F-FDG and 18F-Fluorocholine).
Time Frame
through multidisciplinary concertation meeting an average of 3 days
Title
Modification of the BCLC tumor stage initially evaluated by conventional imaging on the basis of each PET-TDM (18F-FDG alone, 18F-Fluorocholine alone) separately and then the combination of both (combination of PET-TDMs with 18F-FDG and 18F-Fluorocholine
Description
The proportion of modification of the tumor status to a more advanced status in the BCLC classification using PET/CT using 18F-FDG alone, 18F-Fluorocholine alone and then the combination of both in association with conventional imaging compared to conventional imaging alone
Time Frame
through multidisciplinary concertation meeting an average of 3 days
Title
Identification as a HCC of at least one additional tumour lesion using the experimental procedure (each PET-TDM separately and then the combination of both) compared to conventional imaging alone
Description
The proportion of patients with an additional tumor lesion detected by 18F-FDG-PET alone, with 18F-Fluorocholine alone and then the combination of both, whose tumor nature is confirmed histologically or by imaging follow-up
Time Frame
through multidisciplinary concertation meeting an average of 3 days
Title
Description of the differences in diagnostic performance of the experimental procedure compared to the diagnostic gold standard (non-invasive criteria and/or tumor histology)
Description
The proportion of new intrahepatic and/or extrahepatic lesions detected by PET-TDMs at 18F-FDG and 18F-Fluorocholine and confirmed as HCC on histology or by imaging follow-up
Time Frame
through multidisciplinary concertation meeting an average of 3 days
Title
Cost-effectiveness between PET-TDMs at 18F-FDG and 18F-Fluorocholine associated with conventional imaging versus conventional imaging alone
Description
The (incremental) cost-effectiveness ratio of 18F-FDG and 18F-Fluorocholine PET-CTs associated with conventional imaging versus conventional imaging alone
Time Frame
through multidisciplinary concertation meeting an average of 3 days
Title
Number of patients who had an additional examination proposed by the MCM (multidisciplinary consultation meeting) following the PET-TDMs performed
Description
The number of patients who have had an additional complementary examination (biopsy or new imaging for example) proposed by the MCM following 18F-FDG and 18F-Fluorocholine PET-CT scans will be collected prospectively
Time Frame
through multidisciplinary concertation meeting an average of 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients> 18 years old First diagnosis of HCC (no previous treatments received) Diagnosis of HCC according to The European Association for the Study of the Liver (EASL) 2012 criteria by "non-invasive" imaging on cirrhosis or by histology on cirrhosis or non-cirrhotic liver BCLC tumor stage A to C (excluding BCLC C with extrahepatic metastases) according to conventional imaging Will be able to have a PET scanner within 4 weeks after the inclusion visit Ability to stay 20 minutes longer for PET-CT scans Need for oral, intra-uterine or mechanical contraception for women of childbearing age Written consent for participation in the study Having medical insurance coverage Exclusion Criteria: Patients classified BCLC stage 0 (single HCC less than 2 cm) Patients classified as BCLC stage C with extrahepatic metastases Decreased cirrhosis (Child Pugh C) and / or patients with Eastern Cooperative Oncology Group (ECOG) Performance Status 2 to 4 not candidates for liver transplantation Uncontrolled diabetes (defined by blood glucose> 1.7 g / L at the time of inclusion) Hypersensitivity to 18F Fluorocholine or 18F-FDG or any of the excipients Creatinine clearance <40 mL / min Contraindication to MRI: pacemaker or implantable cardiac defibrillator not compatible with MRI, neurostimulator, cochlear implant, intracerebral ferromagnetic vascular clip, intraocular or cerebral metallic foreign bodies, insulin pump Pregnant or lactating woman Patient under tutorship or curatorship or safeguard of justice Known allergy to iodine Patient deprived of liberty by judicial or administrative decision Patients with care "State Medical Aid"
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Charles NAULT, PhD
Phone
01 48 02 41 49
Email
jean-charles.nault@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed RAHAOUI
Phone
01 48 95 59 77
Email
mohammed.rahaoui@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Charles NAULT, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
NAULT
City
Bobigny
ZIP/Postal Code
93000
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
29031662
Citation
Nault JC, Sutter O, Nahon P, Ganne-Carrie N, Seror O. Percutaneous treatment of hepatocellular carcinoma: State of the art and innovations. J Hepatol. 2018 Apr;68(4):783-797. doi: 10.1016/j.jhep.2017.10.004. Epub 2017 Oct 13.
Results Reference
background
PubMed Identifier
28176349
Citation
Cadier B, Bulsei J, Nahon P, Seror O, Laurent A, Rosa I, Layese R, Costentin C, Cagnot C, Durand-Zaleski I, Chevreul K; ANRS CO12 CirVir and CHANGH groups. Early detection and curative treatment of hepatocellular carcinoma: A cost-effectiveness analysis in France and in the United States. Hepatology. 2017 Apr;65(4):1237-1248. doi: 10.1002/hep.28961. Epub 2017 Feb 8.
Results Reference
background
PubMed Identifier
26202754
Citation
Bertagna F, Bertoli M, Bosio G, Biasiotto G, Sadeghi R, Giubbini R, Treglia G. Diagnostic role of radiolabelled choline PET or PET/CT in hepatocellular carcinoma: a systematic review and meta-analysis. Hepatol Int. 2014 Oct;8(4):493-500. doi: 10.1007/s12072-014-9566-0. Epub 2014 Sep 3.
Results Reference
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Learn more about this trial

Combination PET With 18F-fluorodeoxyglucose (18F-FDG) and 18 F-choline in Patient With HCC

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