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

NCT07178587 | Recruiting

• 1 other identifier: RC24_0563
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Hepatocellular Carcinoma (HCC); Gastro-Entero-Pancreatic Tumors (GEPs)

Keywords

Multiplexed PET; basket study; hepatocellulaR carcinoma; gAstro-entero-pancreatic tumors

Outcome Measures

Primary Outcomes (5)

• 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.

  until 30 minutes after first injection of the first radiophamaceutical

• 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.

  within 12 months

• 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.

  within 12 months

• 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.

  within 12 months

• 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.

  within 12 months

Secondary Outcomes (5)

• Visual quality of multiplexed image for clinical use

  within 30 days after the first PET scan

• patients' satisfaction

  within 30 days after the first PET scan

• Ki computation on each of dynamic image acquisitions

  within 12 months

• Tumor normalized uptake values (SUV) (Exploratory analysis)

  within 12 months

• Vd computation on each of dynamic image acquisitions

  within 12 months

Study Arms (2)

Basket HCC

OTHER

Fifteen 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).

Diagnostic Test: Single tracer PET/CT; Diagnostic Test: Multiplexed PET-CT

Basket GEP-NET

OTHER

Thirteen patients with GEP-NET will form cohort 2 (10 patients from the University Hospital of Nantes and Beaujon Hospital).

Diagnostic Test: Single tracer PET/CT; Diagnostic Test: Multiplexed PET-CT

Interventions

Single tracer PET/CT DIAGNOSTIC_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

Basket GEP-NET; Basket HCC

Multiplexed PET-CT DIAGNOSTIC_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.

Basket GEP-NET; Basket HCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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
• Willing and able to follow scheduled visits and study procedure
• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (3)

CHU Brest

Brest, France

NOT YET RECRUITING

Hopital Foch (AP-HP)

Clichy, France

NOT YET RECRUITING

Chu Nantes

Nantes, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Thomas CARLIER, PhD

  Nantes University Hospital

  STUDY CHAIR

• Yann TOUCHEFEU, MD

  Nantes University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: No randomization but patients will be separated in two baskets regarding their pathologies (HCC or GEP-NET)

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: September 17, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)