Hepatocellular carcinoma, primary liver cancer liver cancer
Conditions
Interventions
Included patients will undergo intraprocedural assessment of 99mTc-MAA distribution using SPECT/CBCT imaging acquired by IXSI. When intrahepatic distribution is adequate, and no significant extrahepat
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with hepatocellular carcinoma with a clinical indication for radioembolization that requires a maximum of 2 injection positions as assessed on pre-interventional imaging by an interventional radiologist.The patient must be in adequate physical condition to undergo a procedure that may last up to 2.5 hours.Age = 18 years.Written informed consent.
Exclusion criteria
Exclusion criteria: Patients with aberrant hepatic arterial vascular anatomy that precludes safe microsphere administration in a single session.Any serious and/or chronic liver disease preventing the safe administration of radioembolization.Pregnancy or breastfeeding.Patients who are declared incompetent.Patient length over 1.90 meters (to fit IXSI geometry).Patient bust line over 1.35 meters (to fit IXSI geometry).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstrate the technical success of single session radioembolization procedures through intraprocedural 99mTc-MAA distribution assessment (intrahepatic, extrahepatic, and lung shunt fraction) using imaging acquired by IXSI. Technical success is defined as: 1. the successful intraprocedural evaluation of the 99mTc-MAA distribution, including the ability to assess intrahepatic distribution, identify clinical significant extrahepatic depositions, and calculate the lung shunt fraction; 2. the subsequent successful completion of single-session 90Y radioembolization in cases where 99mTc-MAA distribution was deemed adequate; and 3. there is clinical decision concordance between IXSI SPECT/CBCT and post-treatment conventional SPECT/CT to confirm that the treatment decision to proceed with single-session ?°Y radioembolization would have been performed if conventional SPECT/CT had been used for decision-making. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the safety (quantified as % of adverse events) of performing single session radioembolization procedures through intraprocedural 99mTc-MAA distribution assessment (intrahepatic, extrahepatic, and lung shunt fraction) using imaging acquired by IXSI Report on procedure-related characteristics: Time measurements (including total procedure time and additional required time using IXSI); Radiation dose (total clinical X-ray radiation dose and total additional X-ray radiation dose received from IXSI fluoroscopy and SPECT/CBCT); Number of catheter repositions. 99mTc-MAA distribution (hemo-)dynamics: Dynamic imaging of 99mTc-MAA distribution will be performed using 2D hybrid images acquired by IXSI during injection. This enables visualization of the (hemo-)dynamic processes affecting 99mTc-MAA distribution during administration. | — |
Countries
Netherlands
Contacts
Public ContactN Wijnen
Universitair Medisch Centrum Utrecht
Outcome results
None listed