Actively Recruiting
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
On this page
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
Eligibility Criteria
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
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
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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