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

Trial details

Who runs it

Centre Hospitalier Universitaire De Nantes

Trial code

EU 2024-519505-35-00

Record updated

2025. augusztus 6.

Original description

The main objectives for each basket (HCC and GEP-NET) are: a. Safety of the staggered injection of two radiopharmaceuticals via a single route of administration b. Technical feasibility of the imaging reconstruction after a multiplexed PET scan c. Evaluation of the diagnostic efficacy of multiplexed PET imaging for the detection and staging of both types of tumors compared to single-radiopharmaceutical PET imagingRead full original descriptionShow less

The main objectives for each basket (HCC and GEP-NET) are: a. Safety of the staggered injection of two radiopharmaceuticals via a single route of administration b. Technical feasibility of the imaging reconstruction after a multiplexed PET scan c. 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

Inclusion: Men or women ≥ 18 years; 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 acceptable contraceptive measure (as they will not receive the trial drug) for a duration of 6 months after the multiplexed PET Scan; Male partners will be required to use male contraception (condoms) for a duration of 3 months after the multiplexed PET Scan; 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/MRI (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% (except if AOD). 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).

Exclusion: Any major surgery within 4 weeks before enrollment; Known hypersensitivity to gallium-68, fluor-18 to any excipient or derivative or to radiographic contrast agents; 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; 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; 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.

EU CTIS 2024-519505-35-00