Liver Cancer
Conditions
Brief summary
To establish the safety and feasibility of interventional x-ray and scintigraphy imaging during the pre-treatment procedure of hepatic radioembolization
Interventions
DEVICEIXSI
Hybrid imaging with IXSI will be performed during the radioembolization pre-treatment procedure
Sponsors
UMC Utrecht
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants must have given written informed consent and comply with the requirements 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 radioembolisation 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 pre-treatment radioembolisation procedure.
Exclusion criteria
1. Patients expected to require more than two injection positions for radioembolisation 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 weeks prior to the planned 99mTc-MAA pre-treatment procedure. 8. Radiation therapy within the last 4 weeks before the planned 99mTc-MAA pre-treatment procedure 9. Major surgery within the last 4 weeks prior to the planned 99mTc-MAA pre-treatment procedure 10. Any unresolved toxicity greater than Common Terminology Criteria for Adverse Events (CTCAE version 5) 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 | Description |
|---|---|---|
| Device Feasibility | Immediately after surgery | The feasibility of IXSI will be assessed by questionnaires filled in by interventional radiology personnel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radioactivity distribution over time | Immediately after surgery | The radioactivity distribution in the liver segments will be measured over time to assess potential dynamic behavior |
| Radioactivity distribution in 3D | Immediately after surgery | The quality of IXSI scans will be assessed by measuring the radioactivity distribution in the liver segments in 3D |
Countries
Netherlands
Outcome results
None listed