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Hepatocellular Carcinoma (HCC)ELMIRANCT07178587

Evaluating the roLe of Multiplexed PET Imaging in the Detection and Staging of hepatocellulaR Carcinoma and gAstro-entero-pancreatic Tumors

A study testing Single tracer PET/CT and Multiplexed PET-CT in people with Hepatocellular Carcinoma (HCC) and Gastro-Entero-Pancreatic Tumors (GEPs), run by Nantes University Hospital at 3 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Precision medicine is a major goal in oncology. It aims to tailor treatments to the specific characteristics of each patient's tumor. This approach makes it possible to identify unique therapeutic targets and select the therapeutic alternative that specifically targets the abnormalities identified. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Single tracer PET/CT and Multiplexed PET-CT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
3 sitesFrance
Study dates
2 Feb 2026to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • - Men or women ≥ 18 years
  • Written informed consent
  • Affiliation with French social security system or beneficiary from such system
  • ECOG (Eastern Cooperative Oncology Group) performance ≤ 2
  • Presence of at least one morphological evaluable lesion according to RECIST 1.1 using contrast CT (computer tomography)/MRI (Magnetic Resonance Imaging) (must be performed within 6 months before inclusion)
  • Willing and able to follow scheduled visits and study procedure
Show all 16Show fewer
  • Cohort 1 and 3: Child-Pugh A for cirrhotic patients (initial diagnosis, suspected relapse or progression) with histologically proven diagnosis. Albumin > 28 g/L, total bilirubin < 35 µM/L, TP>50%. The biopsy may have been performed at any point, without time limitations before inclusion.
  • Cohort 2: GEP-NET (initial diagnosis, suspected relapse or progression) with histologically proven with liver metastases and/or pancreatic involvement. The biopsy may have been performed at any point, without time limitations before inclusion.
  • Women must meet one of the following criteria at the time of inclusion:
  • present a negative pregnancy test (blood test) before receiving the first dose of test drug and use highly1 effective contraceptive measures for a duration of 6 months after the multiplexed PET Scan
  • or be post-menopausal (aged over 50 with amenorrhea for at least 12 months after stopping all exogenous hormone treatments);
  • or (if under 50 years of age) have been in amenorrhea for at least 12 months after stopping exogenous hormone treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels corresponding to post-menopausal levels;
  • or have undergone irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented);
  • Male patients will be required to use male contraception (condoms) for a duration of 3 months after the multiplexed PET Scan ;
  • Women partners will be required to use an acceptable2 contraceptive measure (as they will not receive the trial drug) for a duration of 3 months after the multiplexed PET Scan ;
  • Male partners will be required to use male contraception (condoms) for a duration of 6 months after the multiplexed PET Scan.

Who cannot join

  • - Known hypersensitivity to gallium-68, fluor-18 to any excipient or derivative or to radiographic contrast agents.
  • Any major surgery within 4 weeks before enrollment.
  • Any uncontrolled significant medical, psychiatric or surgical condition or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or that would limit compliance with the objectives and assessments of the study.
  • Other known malignancies (except for fully-resected non-melanoma skin cancer or cervical cancer in situ) unless definitively treated and proven no evidence of recurrence for 2 years.
  • Women who are pregnant or breastfeeding. A serum pregnancy test will be performed at the start of the study and within 48 hours prior to multiplexed PET scan for all female subjects of childbearing potential.
  • Patient under guardianship or trusteeship.
  • Patient under judicial protection.
  • Patient unable to understand spoken or written French

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

France3 sites, 3 recruiting

  • CHU Brest

    Brest

    Ronan ABGRAL, MD, 02 98 22 33 27 ext. +33, ronan.abgral@chu-brest.fr

    Ronan ABGRAL, MD

    Not yet recruiting

  • Hopital Foch (AP-HP)

    Clichy

    Rachida LEBTAHI, 01 40 87 51 69 ext. +33, Rachida.lebtahi@aphp.fr

    Rachida LEBTAHI, MD

    Not yet recruiting

  • Chu Nantes

    Nantes

    Clément BAILLY, MD, 02 40 08 31 63 ext. +33, clement.bailly@chu-nantes.fr

    Clément BAILLY, MD

    Recruiting

Other trials in France

About this study

Official title: Evaluating the roLe of Multiplexed PET Imaging in the Detection and Staging of hepatocellulaR Carcinoma and gAstro-entero-pancreatic Tumors: a Basket Diagnostic Performance Study

Precision medicine is a major goal in oncology. It aims to tailor treatments to the specific characteristics of each patient's tumor. This approach makes it possible to identify unique therapeutic targets and select the therapeutic alternative that specifically targets the abnormalities identified. Positron emission tomography (PET) plays a key role in this approach by providing detailed functional imaging of tumors in a non-invasive way. Usually, one radio-tracer is used to perform PET. Depending on the type of tumor, each tracer is carefully selected for its specific behavior and characteristics. However, it may be useful to perform several PET scans with different tracers, each providing different information, for the initial staging and therapeutic management of patients. Hepatocellular carcinoma (HCC), the most common form of liver cancer and the third leading cause of cancer-related death, requires precise imaging for optimal treatment selection. [18F]F-choline PET is often preferred for the initial detection of well-differentiated HCC and local recurrence, while [18F]FDG (fluorodésoxyglucose) PET is more useful for aggressive forms of HCC and for assessing metastases. Similarly, gastro-entero-pancreatic tumors (GEP-NETs), a type of neuroendocrine tumor found in the gastrointestinal tract and pancreas, also benefit from tailored imaging approaches. GEP-NETs commonly express somatostatin receptors, which are effectively targeted by [68Ga]Ga-DOTATOC PET to enhance diagnostic accuracy and staging, particularly in well-differentiated lesions. Conversely, [18F]FDG PET is valuable for imaging GEP-NETs with high metabolic activity, providing insight into tumor aggressiveness and proliferation. The combined use of [18F]FDG PET and [18F]F-choline PET in HCC, as well as [68Ga]Ga-DOTATOC PET and [18F]FDG PET in GEP-NETs, provides complementary information that helps to comprehensively characterize the tumor, guide treatment decisions, and monitor therapeutic response.

In this context, a highly innovative way using multiplexed PET imaging offers potential for targeted therapy and precision medicine. The aim of this study is to evaluate the use of simultaneous dual-tracer PET imaging with a staggered injection (referred to here as multiplexed PET), combining [18F]FDG and [18F]F-choline in HCC, and [68Ga]Ga-DOTATOC and [18F]FDG in GEP-NETs as compared to both pairs of single PET.

Being tested
Single tracer PET/CT, Multiplexed PET-CT
Keywords
Multiplexed PET, basket study, hepatocellulaR carcinoma, gAstro-entero-pancreatic tumors
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single tracer PET/CTDiagnostic test

    Single tracer PET/CT for the HCC patients : one with [18F]FDG and one with [18F]F-choline Single tracer PET/CT for the GEP-NET patients : one with [68Ga]Ga-DOTATOC and one with [18F]FDG

  • Multiplexed PET-CTDiagnostic test

    Multiplexed PET-CT for HCC patients : [18F]FDG + [18F]F-choline. Multiplexed PET-CT for GEP-NET patients : [18F]FDG + [68Ga]Ga-DOTATOC. The PET scans must be performed in any order and at least 24 hours apart.

Study groups in NCT07178587
Study groupRoleWhat they receive
Basket HCCOtherFifteen patients with HCC will be enrolled in either cohort 1 (10 patients from the University Hospital of Nantes and Beaujon Hospital) or cohort 3 (2 patients from the University Hospital of Brest for the ancillary study).
Receives: Diagnostic Test: Single tracer PET/CT; Diagnostic Test: Multiplexed PET-CT
Basket GEP-NETOtherThirteen patients with GEP-NET will form cohort 2 (10 patients from the University Hospital of Nantes and Beaujon Hospital).
Receives: Diagnostic Test: Single tracer PET/CT; Diagnostic Test: Multiplexed PET-CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse reactions collection

    Safety of the staggered injection of two radiopharmaceuticals via a single route of administration will be monitored after multiplexed radiopharmaceuticals administration and until 30 minutes after the end of the image acquisition. Adverse reactions (ARs) will be collected during that period of time.

    Measured: until 30 minutes after first injection of the first radiophamaceutical

  2. Technical Feasibility of the imaging reconstruction

    Technical feasibility will be qualitatively assessed for each patient by the scientific committee at the time of reconstruction of each multiplex acquisition. An image free from artifacts interfering with visual interpretation will be considered as suitable for diagnostic evaluation.

    Measured: within 12 months

  3. Number of positive lesions

    Evaluation of the diagnostic efficacy of multiplexed PET imaging for the detection and staging of both types of tumors compared to single-radiopharmaceutical PET imaging. It will be assessed by the number positive lesions using the multiplexed approach compared to lesions detected with both single-tracer PET scans. The sensitivity of the multiplex imaging over both single-tracer PET will be calculated.

    Measured: within 12 months

  4. Location of positive lesions

    Evaluation of the diagnostic efficacy of multiplexed PET imaging for the detection and staging of both types of tumors compared to single-radiopharmaceutical PET imaging. It will be assessed by the location of positive lesions using the multiplexed approach compared to lesions detected with both single-tracer PET scans. The sensitivity of the multiplex imaging over both single-tracer PET will be calculated.

    Measured: within 12 months

  5. quantitative information of positive lesions

    Evaluation of the diagnostic efficacy of multiplexed PET imaging for the detection and staging of both types of tumors compared to single-radiopharmaceutical PET imaging. It will be assessed by the quantitative information of positive lesions using the multiplexed approach compared to lesions detected with both single-tracer PET scans. The sensitivity of the multiplex imaging over both single-tracer PET will be calculated.

    Measured: within 12 months

Secondary outcomes (5)

  1. Visual quality of multiplexed image for clinical use

    A global assessment will be given for each multiplex imaging for the use in clinical practice. This assessment will then be summarised and presented by basket.

    The following scoring system will be used:

    • Noise quantification : 0. No noise / 1. Moderately increased noise / 2 Highly increased noise
    • Artifact detection: 0. No artifact/ 1. Presence of non-invasive artifact / 2. Presence of invasive artifact A score of 3 or more indicates poor imaging quality.

    Measured: within 30 days after the first PET scan

  2. patients' satisfaction

    Acceptability will be assessed using an ordinal scale from 1 (very uncomfortable) to 5 (very comfortable) and a one-question survey asking participants to indicate their preference between undergoing two separate single-tracer PET scans or one multiplexed PET scan

    Measured: within 30 days after the first PET scan

  3. Ki computation on each of dynamic image acquisitions

    Exploratory analysis for patients who agreed to have dynamic whole body acquisition : Ki (capture kinetics min-1) computation on each of dynamic image acquisitions

    Measured: within 12 months

  4. Tumor normalized uptake values (SUV) (Exploratory analysis)

    Exploratory analysis for patients who agreed to have dynamic whole body acquisition : Tumor normalized uptake values (SUV) will be determined on each imaging PET to evaluate whether dynamic PET/CT (computing tomography) imaging (including multiplexed imaging) improves lesion detection compared with static PET/CT

    Measured: within 12 months

  5. Vd computation on each of dynamic image acquisitions

    Exploratory analysis for patients who agreed to have dynamic whole body acquisition : Vd (volume of distribution) computation on each of dynamic image acquisitions

    Measured: within 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2025
  2. Study start2 Feb 2026
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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
Non-randomised
Intervention model
Single group
Model description
No randomization but patients will be separated in two baskets regarding their pathologies (HCC or GEP-NET)
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07178587
Sponsor's protocol ID
RC24_0563
Acronym
ELMIRA
Status last verified
Feb 2026
First submitted
18 Aug 2025
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Single tracer PET/CT and Multiplexed PET-CT in people with Hepatocellular Carcinoma (HCC) and Gastro-Entero-Pancreatic Tumors (GEPs), run by Nantes University Hospital at 3 sites 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 16 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse reactions collection (time frame: until 30 minutes after first injection of the first radiophamaceutical). The study lists 5 primary outcomes in all. 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 NCT07178587.

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 3 Feb 2026.

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