hepatocellular carcinoma / liver metastases
Conditions
Interventions
Angiographic work-up will be identical to the standard procedure up to the point of 99mTc-MAA injection. Then, 2D imaging of the controlled injection of 99mTc-MAA using IXSI is performed, followed by
Sponsors
UMC Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: Participants will be recruited from patients, which are clinically selected to undergo a radioembolisation treatment at the UMC Utrecht. This will be adult men and women with liver tumour(s), that have no curative treatment options. The patient’s indication for hepatic radioembolisation will be discussed in a multidisciplinary tumour board. In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Participants must have given written informed consent and comply with the re-quirements of the study protocol. 2. Must be aged 18 years or over. 3. Must be selected to undergo a 99mTc-MAA procedure as part of their radioembolisa-tion treatment. 4. Sufficiently fit to undergo an additional examination time of 30-90 minutes. 5. Have a CT acquired less than 6 weeks before the pretreatment radioembolisation procedure.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Patients expected to require more than two injection positions for radioembolisa-tion treatment. 2. Pregnancy or nursing. 3. Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression. 4. Patients who are declared incompetent. 5. Previous enrollment in the present study 6. Claustrophobia 7. The last dose of prior chemotherapy has been received less than 4 weeks prior to the planned 99mTc-MAA pretreatment procedure. 8. Radiation therapy within the last 4 weeks before the planned 99mTc-MAA pretreat-ment procedure 9. Major surgery within the last 4 weeks prior to the planned 99mTc-MAA pretreatment procedure 10. Any unresolved toxicity greater than Common Terminology Criteria for Adverse Events (CTCAE version 5, see appendix A) grade 2 from previous anti-cancer treatment 11. Body weight over 250 kg (because of maximum table load) 12. Patient length over 1.90 m (to fit IXSI geometry) 13. Patient bust line over 135 cm (to fit IXSI geometry)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: •To establish the safety of acquiring 2D and 3D hybrid images using IXSI in an interventional setting. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: • To establish the clinical usability of dosimetry based on interventional SPECT/CBCT using IXSI compared to traditional SPECT/CT based dosimetry after the pretreatment procedure. • To image the (hemo-)dynamic processes influencing the microsphere distribution during the administration of 99mTc-MAA, using IXSI. | — |
Contacts
Public ContactHugo de Jong
UMC Utrecht
Outcome results
None listed