GALLIUM (68GA) EDOTREOTIDE for Hepatocellular carcinoma | Gastroenteropancreatic neuroendocrine tumor (GEP-NET)

Inclusion criteria

• {"criterion_text":"- Men or women ≥ 18 years"}
• {"criterion_text":"- Male patients will be required to use male contraception (condoms) for a duration of 3 months after the multiplexed PET Scan"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Male partners will be required to use male contraception (condoms) for a duration of 3 months after the multiplexed PET Scan."}
• {"criterion_text":"- Written informed consent"}
• {"criterion_text":"- Affiliation with French social security system or beneficiary from such system"}
• {"criterion_text":"- ECOG (Eastern Cooperative Oncology Group) performance ≤ 2"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Willing and able to follow scheduled visits and study procedure"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Women must meet one of the following criteria at the time of inclusion: •\tpresent 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 •\tor be post-menopausal (aged over 50 with amenorrhea for at least 12 months after stopping all exogenous hormone treatments); •\tor (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; •\tor have undergone irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented);"}

Exclusion criteria

• {"criterion_text":"- Known hypersensitivity to gallium-68, fluor-18 to any excipient or derivative or to radiographic contrast agents."}
• {"criterion_text":"- Any major surgery within 4 weeks before enrollment."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patient under guardianship or trusteeship"}
• {"criterion_text":"- Patient under judicial protection"}
• {"criterion_text":"- patient unable to understand spoken or written French"}

Primary endpoints

• {"endpoint_text":"- Safety 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.","definition_or_measurement_approach":"Safety monitoring period defined as up to 30 minutes after end of image acquisition; collection of adverse reactions (ARs) during that period."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Qualitative assessment by the scientific committee at reconstruction time; images free from artifacts that interfere with visual interpretation considered suitable for diagnostic evaluation."}
• {"endpoint_text":"- The efficacy of multiplexed PET imaging will be assessed by the number, location and quantitative information of positive lesions using the multiplexed approach compared to lesions detected with each single-tracer PET scan. Two independent experts will evaluate both single- tracer PET scans, and the multiplexed scan in order to quantify and localize each detected lesion. All experts will be blinded to the results of the other imaging technique","definition_or_measurement_approach":"Comparison of number, location and quantitative metrics of positive lesions between multiplexed and single-tracer PET; two independent blinded experts evaluate scans to quantify and localize detected lesions."}

Secondary endpoints

• {"endpoint_text":"- Visual scale grading of multiplexed image for quality assessment (low, acceptable,","definition_or_measurement_approach":"Visual quality grading using a scale (low, acceptable, optimal) for multiplexed images."}
• {"endpoint_text":"- Acceptability will be assessed using an ordinal scale from 1 (very uncomfortable) to 5 (very comfortable) and a one-question survey asking participants to indicate their preference between undergoing two separate single-tracer PET scans or one multiplexed PET scan","definition_or_measurement_approach":"Participant acceptability measured by an ordinal scale (1–5) and a single-question preference survey comparing two separate single-tracer PET scans vs one multiplexed PET scan."}
• {"endpoint_text":"- Ki and Vd computation on each of dynamic image acquisitions (Exploratory analysis for patients who agreed to have dynamic whole body acquisition)","definition_or_measurement_approach":"Computation of pharmacokinetic parameters Ki and Vd from dynamic image acquisitions for participants who consent to dynamic whole-body acquisition (exploratory analysis)."}
• {"endpoint_text":"- Tumor normalized uptake values (SUV) will be determined on each imaging PET (Exploratory analysis for patients who agreed to have dynamic whole body acquisition)","definition_or_measurement_approach":"Determination of tumor standardized uptake values (SUV) on each PET imaging; analysis exploratory for participants undergoing dynamic whole-body acquisition."}

France

Earliest CTIS Part Ii Submission Date

10-06-2025

Latest Decision Or Authorization Date

06-08-2025

Processing Time Days

57

Number Of Sites

4

Number Of Participants

28

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nantes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Agence Nationale pour la Recherche","duties_or_roles":"Monetary support","organisation_type":""}