Multiplexed PET imaging for detecting and staging liver and gastro‑entero‑pancreatic tumors

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

This study will try using multiple PET tracers to see if combined scans better detect and stage hepatocellular carcinoma and gastro‑entero‑pancreatic tumors in adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nantes University Hospital (Academic / other)
• Locations: 3 sites (Brest and 2 other locations)
• Trial ID: NCT07178587 on ClinicalTrials.gov

What this trial studies

This interventional basket trial compares standard single‑tracer PET/CT with multiplexed PET‑CT using several radiotracers to obtain complementary functional information. Adults with histologically proven hepatocellular carcinoma (HCC) or gastro‑entero‑pancreatic neuroendocrine tumors (GEP‑NETs) who have at least one RECIST‑evaluable lesion and ECOG ≤ 2 will be enrolled. Participants will undergo both single‑tracer and multiplexed PET‑CT scans alongside conventional contrast CT or MRI for staging and management planning. Imaging results will be analyzed by cohort and correlated with clinical and laboratory data, with specific inclusion criteria for cirrhotic HCC patients (Child‑Pugh A).

Who should consider this trial

Good fit: Adults (≥18) with histologically proven HCC (Child‑Pugh A if cirrhotic) or GEP‑NET with liver metastases and/or pancreatic involvement, ECOG ≤ 2, and at least one RECIST‑evaluable lesion are ideal candidates.

Not a fit: Patients with more advanced liver dysfunction (Child‑Pugh B or C), no evaluable lesion on recent CT/MRI, inability to undergo PET/CT, or lack of affiliation with the French social security system are unlikely to benefit.

Why it matters

Potential benefit: If successful, combining PET tracers could improve detection and staging accuracy and help doctors choose the most appropriate treatment.

How similar studies have performed: Previous small studies of dual‑ or multi‑tracer PET imaging have shown promising improvements in lesion detection for some tumor types, but large confirmatory trials remain limited.

Eligibility criteria

Inclusion Criteria:

* \- 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
* 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.

Exclusion Criteria:

* \- 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

Where this trial is running

Brest and 2 other locations

• CHU Brest — Brest, France (Not_yet_recruiting)
• Hopital Foch (AP-HP) — Clichy, France (Not_yet_recruiting)
• Chu Nantes — Nantes, France (Recruiting)

Conditions Hepatocellular Carcinoma; Gastro-Entero-Pancreatic Tumors; Multiplexed PET; basket study; hepatocellulaR carcinoma; gAstro-entero-pancreatic tumors