IXSI: Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA during the radioembolisation pretreatment procedure

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

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 4 weeks
prior to the planned 99mTc-MAA pretreatment procedure.
8. Radiation therapy within the last 4 weeks before the planned 99mTc-MAA
pretreatment 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 1) 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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety of the use of IXSI in an interventional setting. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Comparison of dosimetry (lung shunt fraction (LSF), tumour to non-tumour ratio<br /><br>(T/N ratio) and dose to liver segments) based on IXSI and conventional<br /><br>SPECT/CT.<br /><br>Visual inspection of 2D images of 99mTc-MAA administration.</p><br>