Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07178587

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

Led by Nantes University Hospital · Updated on 2026-02-03

28

Participants Needed

3

Research Sites

56 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men or women aged 18 years or older
  • Written informed consent provided
  • Affiliated with or beneficiary of the French social security system
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • At least one tumor lesion visible on contrast CT or MRI within 6 months before inclusion, evaluable by RECIST 1.1
  • Willing and able to attend scheduled visits and follow study procedures
  • For cirrhotic patients in cohorts 1 and 3: Child-Pugh A classification with histologically confirmed diagnosis, albumin > 28 g/L, total bilirubin < 35 µM/L, prothrombin time > 50%
  • For cohort 2: Histologically confirmed GEP-NET with liver metastases and/or pancreatic involvement
  • Women must either have a negative pregnancy test before first dose and use highly effective contraception for 6 months after PET scan, be post-menopausal, have documented surgical sterilization, or have confirmed menopausal hormone levels if under 50
  • Male patients must use condoms for 3 months after PET scan
  • Female partners must use acceptable contraception for 3 months after PET scan
  • Male partners must use condoms for 6 months after PET scan
Not Eligible

You will not qualify if you...

  • Known allergy or hypersensitivity to gallium-68, fluor-18, related compounds, or contrast agents
  • Major surgery within 4 weeks before enrollment
  • Uncontrolled significant medical, psychiatric, or surgical conditions that could affect safety or study compliance
  • Other cancers unless fully treated and no recurrence for at least 2 years, except fully resected non-melanoma skin cancer or cervical cancer in situ
  • Pregnant or breastfeeding women
  • Patients under legal guardianship or judicial protection
  • Inability to understand spoken or written French

AI-Screening

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Trial Site Locations

Total: 3 locations

1

CHU Brest

Brest, France

Not Yet Recruiting

2

Hopital Foch (AP-HP)

Clichy, France

Not Yet Recruiting

3

Chu Nantes

Nantes, France

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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