Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT06735560
Eligibility Criteria:
Inclusion Criteria:
1. Provided written informed consent.
2. Patients aged ≥ 18 years.
3. \- For basket 1 and 2: HCC or ICC histologically proven: newly diagnosed patients or patients with suspected refractory, residual, or recurrent disease.
\- For basket 3: GEP-NENs (2019 WHO classification), functioning or non-functioning, for the staging of patients with no, low or heterogeneous SSTR2 expression (who may be considered not eligible for PRRT with radiolabelled so- matostatin analogs).
4. Presence of at least one morphological evaluable lesion according to RECIST 1.1 using contrast CT/MRI.
5. Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2.
6. For cirrhotic patients: Child-Pugh ≤ B7.
7. Patient affiliated to or beneficiary of the National Health Service.
Exclusion Criteria:
1. Known hypersensitivity to zirconium-89, to any excipient or derivative or to radiographic contrast agents.
2. Chemotherapy, extensive external beam radiation, immunotherapy, targeted therapy, or angiogenesis inhibitors within 2 weeks prior to inclusion.
3. Radionucleide targeted therapy prior to inclusion within 6 months prior to inclusion.
4. Radioembolization within 3 months prior to inclusion.
5. Uncontrolled brain or spinal cord metastasis. Patients with a history of brain metastases must have a head CT or MRI with contrast to document stable brain disease 3 months prior to inclusion in the study.
6. Cardiac disease with New York Heart Association classification of III or IV.
7. Life expectancy shorter than 4 months.
8. Any major surgery within 4 weeks before enrollment.
9. Any uncontrolled significant medical, psychiatric or surgical condition (active infection (subjects with known human immunodeficiency virus (HIV) positive)), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus (glycated haemoglobin (HbA1c) ≥9%), uncontrolled congestive heart disease, etc.) 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.
10. 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.
11. Women who are pregnant or breastfeeding. A serum pregnancy test will be performed at the start of the study for all female subjects of childbearing potential.
12. Patient under guardianship or trusteeship.
13. Patient under judicial protection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06735560
Study Brief:
Protocol Section:
NCT06735560