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New treatment option for Hepatocellular Carcinoma (HCC)
Official title Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, BTC or NEN
ClinicalTrials.gov ID: NCT06735560
What this study is testing
- What it's testing
- Precision medicine represents a major goal in oncology. It has its underpinning in the identification of biomarkers with diagnostic, prognostic, or predictive values.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provided written informed consent.
- Patients aged ≥ 18 years.
- \- For basket 1 and 2: HCC or ICC histologically proven: newly diagnosed patients or patients with suspected refractory, residual, or recurrent...
- Presence of at least one morphological evaluable lesion according to RECIST 1.1 using contrast CT/MRI.
- Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2.
You likely can't join if
- Known hypersensitivity to zirconium-89, to any excipient or derivative or to radiographic contrast agents.
- Chemotherapy, extensive external beam radiation, immunotherapy, targeted therapy, or angiogenesis inhibitors within 2 weeks prior to 89Zr-TLX250...
- Radionucleide targeted therapy prior to inclusion within 3 months prior to inclusion.
- Radioembolization within 3 months prior to inclusion.
- Uncontrolled brain or spinal cord metastasis.
- Cardiac disease with New York Heart Association classification of III or IV.
See the full eligibility criteria
- Provided written informed consent.
- Patients aged ≥ 18 years.
- \- 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: Progressive GEP-NENs with low or heterogeneous...
- Presence of at least one morphological evaluable lesion according to RECIST 1.1 using contrast CT/MRI.
- Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2.
- For cirrhotic patients: Child-Pugh ≤ B7.
- Patient affiliated to or beneficiary of the National Health Service.
- Known hypersensitivity to zirconium-89, to any excipient or derivative or to radiographic contrast agents.
- Chemotherapy, extensive external beam radiation, immunotherapy, targeted therapy, or angiogenesis inhibitors within 2 weeks prior to 89Zr-TLX250 administration.
- Radionucleide targeted therapy prior to inclusion within 3 months prior to inclusion.
- Radioembolization within 3 months prior to inclusion.
- Uncontrolled brain or spinal cord metastasis.
- Cardiac disease with New York Heart Association classification of III or IV.
- Life expectancy shorter than 4 months.
- Any major surgery within 4 weeks before enrollment.
- Any uncontrolled significant medical, psychiatric or surgical condition (active infection (people with known human immunodeficiency virus (HIV) positive)), unstable angina pectoris, cardiac arrhythmia, poorly controlled...
- 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 for all female people of childbearing potential.
- Patient under guardianship or trusteeship.
- Patient under judicial protection.
The study team makes the final eligibility decision.
Where it's taking place
- Nantes, France
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantes, France; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.